General Surgery News (September 2020)

OP INION Is There a Magic Bullet for COVID-19? Page 22

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

September 2020 • Volume 47 • Number 9

Mesh-Free Hernia Repair Works Well In Selected Patients

Surgical Smoke: A Potential Risk Too Real to Ignore Any Longer

A Word of Warning About Nerve Injury

By CHRISTINA FRANGOU

cigarettes (J Plast Reconstr Aesthet Surg. 2012;65[7]:911916), and another showed that perioperative nurses reported twice as many respiratory issues as the general population (ORNAC J 2012;30[1]:14-16, 18-19, 35-37).

It’s not just exposure to carcinogens that has providers worried. Biological substances considered to be mutagenic and possibly infectious, including malignant cells and viruses, also have been detected in surgical smoke (J Cancer 2019;10[12]:

riting in the journal Hernia, surgeons have introduced a new minimally invasive, mesh-free repair for small, low-risk inguinal hernias.

They caution that patient selection is key for this repair, with only a small minority of inguinal hernia patients suited for this approach.

In 2015, Shirin Towfigh, MD, and her colleagues developed the robotic iliopubic tract repair—r-IPT for short—and tested it in a pilot study of 13 patients with 24 hernias. With a mean follow-up of 24.9 months (range, 2.7-55 months), one patient had

Continued on page 3

Continued on page 16

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By CHASE DOYLE

T

he price for saving lives in the OR could be the healthy lungs of surgical teams.

Mounting evidence indicates that surgical smoke, the byproduct of procedures using electrocautery and other heat-producing devices, may pose a serious risk to health care workers. One study to quantify exposure found that a single day in the OR is the equivalent of smoking up to 30 unfiltered IN MEMORIAM

Morris Franklin, MD Surgical Visionary, Teacher

OPINION

Practice Value: Top Breast Cancer Papers Reviewed

Are We the COVID-19 Surgeons?

By MONICA J. SMITH

By IOANA BAIU, MD, MPH

R

C

By CHRISTINA FRANGOU

D

r. Morris Emory Franklin Jr., a renowned surgeon and an educator whose innovative work in minimally invasive techniques shaped the history of modern surgery, died Aug. 2, 2020, after emergency surgery.

In interviews he gave to General Surgery News over the past two decades, he referred to himself as a private practice surgeon in Texas. But that description belies the enormity of Dr. Franklin’s influence

esearchers published nearly 25,000 articles related to breast cancer in 2019. As part of the American Society of Breast Surgeons Virtual Education Series, held in lieu of the traditional annual meeting, Helen Pass, MD, described the papers she considered the best.

“I selected landmark studies, papers that have significant practice value, and research that received a lot of media attention, prompting patients to ask about them; and that segues us into the first paper,” said Dr. Pass, the chief

Continued on page 8

IN THE NEWS

4 First Look: Updates From SAGES 6 First Look: Updates From MISS J OURNAL WATCH

14 Recently-Published Studies in Colorectal, Hernia Surgery . facebook.com/generalsurgerynews

@gensurgnews

Continued on page 18

hief year. The crème de la crème, the ultimate year and profoundly forming experience that every general surgery resident inevitably lives through. These final 12 months metamorphose residents into attendings, from using a needle driver to being slick with it, from following plans to leading a team and directing patient care. The knowledge and the skills are present, but chief year refines residents Continued on page 23

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IN THE NEWS

SEPTEMBER 2020 / GENERAL SURGERY NEWS

Surgical Smoke continued from page 1

2788-2799). Although the long-term consequences of exposure remain unclear, in the age of COVID-19, many health care workers are finally starting to heed the signal.

It is estimated that 90% of all endoscopic and surgical procedures produce plume, and approximately a half-million health care workers are exposed to laser or electrosurgical smoke each year (Am J Ind Med 2016;59[11]:1020-1031).

Despite the potential dangers, only two states—Colorado and Rhode Island— have laws requiring that hospitals and ambulatory surgery centers adopt policies to use a smoke evacuation system for surgical procedures that generate surgical smoke. Rhode Island’s law went into effect Jan. 1, 2019, and Colorado’s will take effect May 2021.

During the 2020 Association of periOperative Registered Nurses Virtual Global Surgical Conference, Jennifer Pennock, MS, the senior manager of governmental affairs for AORN, provided an update on surgical smoke evacuation legislation in the rest of the United States.

This year, legislation has been introduced in eight states: Connecticut, Georgia, Illinois, Iowa, Kentucky, Oregon, Tennessee and Utah. Unfortunately, Ms.

Pennock said, COVID-19 had a negative impact on many of these bills, including legislation in New Jersey that was not yet introduced this year but was anticipated.

The pandemic may have delayed legislative efforts in several states, but there are lessons to be learned from the few sessions that have taken place so far, said Ms. Pennock, who noted that the primary opposition to legislation has come from state hospital associations and state chapters of the American College of Surgeons.

become an even more pressing issue during the pandemic. Mark K. Soliman, MD, a consultant surgeon of the Florida Hospital Cancer Institute and the UF Health Cancer Center, in Gainesville, told General Surgery News that although aerosolized SARS-CoV-2 has not yet been isolated in cauterized tissue or surgical smoke, the virus has been detected in peritoneal fluid. Using appropriate protection therefore is imperative until proven otherwise.

One study to quantify exposure found that a single day in the OR is the equivalent of smoking up to 30 unfiltered cigarettes, and another showed that perioperative nurses reported twice as many respiratory issues as the general population.

“One misconception expressed by policymakers and others is that surgical smoke is not a problem because they were not aware of it before,” Ms. Pennock said. “It’s difficult to introduce a solution to a problem when it’s the first time that legislators are hearing that there even is a problem, and when no complaints have previously been made.”

Although COVID-19 may have impeded surgical smoke legislation, reducing exposure to surgical smoke has

“There’s no doubt that COVID-19 [virus] has been detected in ascites, which is a big deal,” Dr. Soliman said. “A lot of this remains speculative, but for minimally invasive surgery, you have to maintain a closed circuit with proper filtrations. If you don’t have proper filtration, then you are putting people theoretically at risk.”

That does not mean minimally invasive surgery is more hazardous than traditional surgery amid the current crisis. In fact, Dr. Soliman, because the operations

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are performed within a confined space, minimally invasive surgery may be the safer option if surgery cannot be delayed.

“When a closed circuit is maintained within the intraabdominal environment, there is a chamber in which all the smoke is contained, and there are only a few points of exit called the trocar sites,” Dr. Soliman explained. “If the surgical team controls smoke evacuation, minimally invasive surgery may be the way to go.”

Although it may have taken surgeons a long time to recognize and acknowledge the risks associated with surgical smoke, the pandemic is finally giving the issue the attention it deserves, according to Dr. Soliman.

“Surgical smoke is one of those things that surgeons, myself included, have been completely blind to,” he noted. “I didn’t even consider it, truthfully. It wasn’t until COVID-19 that we actually started doing more research, discussing the issue, and being more thoughtful about the problem.”

Now, Dr. Soliman and his colleagues are taking all the necessary precautions.

“The days of casually walking into an OR as a buddy of mine is operating and chatting with a mask on are gone,” he concluded. “Until we have better data and more robust clinical trials looking at this, I think we need to proceed with maximal caution as opposed to ignorance.”

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IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2020

First Look: SAGES 2020 Virtual Meeting All Articles by CHRISTINA FRANGOU

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) converted its annual meeting to a successful virtual meeting in August. Here, General Surgery News highlights three of the “Best Papers” as selected by SAGES.

Endoscopic Skills Test: Inequity Concerns in Surgical Technology and Training

A

n analysis of graduating residents’ scores on the Fundamentals of Endoscopic Surgery (FES) skills test showed men were 30% more likely to pass than women, with pass rates of 92% compared with 71%.

This gap does not reflect inherent differences in ability by sex but very likely results from systemic issues in the way flexible endoscopy is trained and performed, said lead author Matthew Lineberry, PhD, an associate professor at the Zamierowski Institute for Experiential Learning at the University of Kansas Medical Center, in Kansas City.

“It doesn’t seem likely to us that the test itself is biased but rather that it seems to be revealing bias in other aspects of training and surgery,” Dr. Lineberry said.

A contributing factor may be device design, he said. Many instruments are designed for larger hands. A person with a glove size 5.5 cannot wrap their ring and pinky fingers completely around the handle shaft of a colonoscope, leading to reduced grip security.

The full paper is published in Surgical Endoscopy (2020; 34[8]:3633-3643). It includes photos illustrating the effects of hand size on instrument control and a detailed discussion of potential explanations for the sex-related difference.

Investigators analyzed de-identified, first-attempt skills test scores and self-reported demographic characteristics of 2,023 general surgery residents who were required to pass the FES assessment.

Residents’ sex, glove size and height were closely correlated, but statistically controlling for glove size and height did not eliminate the sex difference in scores.

The overall pass rate was 83%. Results showed that the volume of a resident’s clinical experience correlated with passing, especially for colonoscopy and lower gastrointestinal tract procedures. But residents’ performance on each of the five tasks required skills only moderately related to their performance on the other four. Loop reduction was the most difficult of the subtasks, analysis showed.

A previous study suggested the FES simulator GI Mentor Express was associated with higher scores, so investigators applied a conversion factor to tests on this simulator to correct for perceived bias. However, examinees who tested on this simulator had lower total scores and a lower pass rate than those on the GI Mentor II, at 73% compared with 85%. When investigators removed the Express-specific scoring rule, the disparity was eliminated.

The Express simulator‒specific scoring penalty should be removed from the FES test, Dr. Lineberry said.

In an accompanying commentary published in Surgical Endoscopy, three noted SAGES members wrote that the study raises issues that the FES committee “can and should wrestle with,” especially sex-related differences in pass rates.

“The results add to the call for a critical assessment of the entire paradigm of surgical development in light of its male-dominated origins,” they wrote, adding that the field should “welcome, celebrate and benefit from the contributions of a much more diverse set of providers and trainers than we have historically enjoyed, and in some cases, allowed.”

All Barrett’s Esophagus Should Be Biopsied, Study Indicates

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biopsy should be performed for all cases of Barrett’s esophagus, regardless of length, according to researchers in the United Kingdom.

They called for changes in surveillance protocols after a study showed that a substantial proportion of dysplasia and adenocarcinoma occurs in ultra-short or short-segment Barrett’s, which is often diagnosed on index endoscopy but would not meet the standard for interval surveillance.

“We propose that all lengths of columnar-lined epithelium above the gastroesophageal junction when seen on endoscopy are recognized as Barrett’s esophagus [BE] and subjected to a thorough biopsy protocol,” said researcher Jenifer Barrie, MD, PhD, of the Sheffield Teaching Hospitals.

Both the American College of Gastroenterology and British Society of Gastroenterology guidelines ignore BE of shorter than 1 cm in their surveillance recommendations. They focus on longer segments but concede the evidence is poor quality.

Dr. Barrie and her colleagues looked at the length of BE and its relationship to dysplasia and esophageal adenocarcinoma (EAC) in three groups of patients.

In the first group, consisting of 160 patients with dysplastic BE over a five-year period, 20% with low-grade dysplasia had BE less than 1 cm and 48.5% had BE less than 3 cm; among those with high-grade dysplasia, 18% had BE less than 1 cm and 40.9% had BE less than 3 cm. Two-thirds of patients were diagnosed on index endoscopy.

The second group of patients included 100 consecutive cases of EAC over a one-year period. Of these, 22% of EAC was diagnosed within 1 cm of the gastroesophageal junction and 40% within 3 cm.

Barrett’s esophagus was visible above the tumor in only seven cases.

In the third group, 100 consecutive nondysplastic BE cases over a 15-month period were assessed from a cohort of 438 consecutive gastroscopies by a single endoscopist. Of these cases, 53% had BE less than 1 cm from the gastroesophageal junction.

“This would lead us to postulate that the current system of Barrett’s surveillance will not pick up a portion of adenocarcinoma and dysplasia, as columnar-lined epithelium less than 1 cm is disregarded from diagnosis and surveillance,” Dr. Barrie said.

Surveillance-detected cancers have a better prognosis but only 3% to 8% of EAC is currently diagnosed by surveillance.

No Benefit of ‘Cooling Off’ Period Before Ileocolic Resection for Complicated Crohn’s

D

elaying ileocolic resection (ICR) in patients with complicated Crohn’s ileitis does not reduce perioperative complications compared with early surgery, a new review suggests.

The finding comes from a retrospective review of 92 patients who underwent ICR for Crohn’s ileitis with intraabdominal abscess, phlegmon or contained perforation confirmed on diagnostic imaging. The study represents the largest contemporary cohort of surgical patients with this condition.

Between 2013 and 2019, 65 patients treated at Mount Sinai Hospital in New York City, underwent initial nonoperative management with antibiotics, bowel rest and/or percutaneous drainage followed by a “cooling off ” period before ICR, and 27 patients underwent surgical resection within 72 hours of imaging.

The mean time from diagnosis to surgery was two days in the immediate resection patients and 35 days for delayed resection, with a range of four to 307 days in the latter group.

All patients who had early surgery and 94% with delayed surgery were treated laparoscopically.

Conversion to open surgery occurred in 11% and 15%, respectively, which was not a statistically significant difference.

Comparing early with delayed resection, there were no significant differences in operating room time (140.1 vs. 151.7 minutes), estimated blood loss (106.5 vs. 130.5 mL), extended resection (7.4% vs. 10.8%), and intraoperative fecal diversion (3.7% vs. 3.1%). However, patients who had a delayed resection underwent more additional procedures at the time of surgery (69.2% vs. 44.4%). These procedures included small bowel resections, fistula takedowns and colonic resections.

There was no significant difference between the groups in surgical site or organ space infection within 30 days, transfusions, readmission, total hospital length of stay or days from operation to discharge.

“An early surgical resection can safely be performed laparoscopically without an increased rate of conversion or need for fecal diversion,” said study co-author Daniel Peyser, MD, a surgical resident at New York-Presbyterian Hospital, in New York City.

Patients in the two groups were similar, with no significant difference in age, sex, body mass index, preoperative lab results, or use of preoperative steroids or biologics.

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IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2020

First Look: Minimally Invasive Surgery Symposium 2020 (Virtual) 20thth ANNIVERSARY!

By COLLEEN HU TCHINSON

s COVID-19 first crept up on the world and then stormed it with the increase in cases and clusters across the nation, surgical and other health care associations and entities had difficult decisions to make. Philip Schauer, MD, the executive director of the Minimally Invasive Surgery Symposium (MISS), and staff carefully considered the best plan for the 20th annual MISS that was to be held in Las Vegas, in March—the tipping point of COVID-19.

The prospect of canceling the in-person

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anniversary event was disappointing, but staff quickly rallied, defying the odds to develop and execute a robust, full-agenda online virtual conference in just two months. Presenters and staff together worked to create a virtual conference that included panel presentations, live debates, continuing medical education and industry-sponsored educational events—all of which are available for online viewing at any time.

Always known for its dynamic and current coverage of the latest techniques and technologies in minimally invasive surgery, this year’s virtual MISS2020 did not disappoint. Coverage of

2020 Minimally Invasive Surgery Symposium MISS2020 will continue over the next few issues of General Surgery News, as we interview presenters and faculty of some of the most critical presentations from the meeting.

Visit www.globalacademycme.com/conferences/miss/register to register and access part or all of the virtual MISS2020.

My Experience with TAR: The Good, The Bad and The Ugly

The Concept of the Critical View w Of the Myopectineal Orifice

Presenter: Michael Rosen, MD, professor of surgery, Cleveland Clinic Foundation, Cleveland

Presenter: Jorge Daes, MD, FACS, academic director off the Minimally Invasive Surgery Department at ClÍnica Portoazul, in Barranquilla, Colombia; he is a recent past president of the Colombian Surgical Association

COLLEEN HUTCHINSON: Seeing as many complex hernia cases as you do in your hernia center, you are a great barometer for what we thought worked in hernia repair, what we think might work and what actually ends up working long term. Please share with us your experience historically with transversus abdominis muscle release (TAR).

DR. ROSEN: Here it is, broken down into the good, the bad and the ugly.

The good: This operation was originally intended to repair large complex ventral hernias in an open fashion while avoiding skin flaps, placing large prosthetic devices in an extraperitoneal position to allow less expensive larger pore material that is potentially more infection resistant. It was particularly suited for lateral defects closer to bony structures, loss of domain and contaminated cases by exploiting the retroperitoneum.

The bad: Many of us were extremely excited with our early results in high-volume centers with fellowship-trained surgeons seeing primarily complex hernias, and we began pushing this procedure as the best operation for all hernias. As a result, it has become a surgical dogma that any intraperitoneal mesh is bad, and we as surgeons should do everything we can to place mesh in an extraperitoneal position, even for small routine defects. Several innovative minimally invasive surgery (MIS) approaches have lowered the threshold even further to attempt these advanced procedures. This has unintentionally resulted in what appears to be overutilization of MIS retromuscular repairs for small defects in an attempt to get the mesh out of the peritoneal cavity at all costs.

The ugly: We are now seeing many devastating complications as a direct result of the overaggressive dissection of the abdominal wall, leading to lateral hernias, breakdowns in the posterior sheath closures and denervations of large segments of the abdominal wall. It is concerning that the cure for intraperitoneal mesh placement [IPOM] might be worse than the disease of IPOM mesh.

Expert Commentary GUY VOELLER, MD: We should pay close attention to what a world authority such as Dr.

Rosen is trying to tell us. He is in charge of one of the busiest hernia centers in the world for complex hernia repair, and he sees all of the disasters on which he speaks.

While TAR is a wonderful technique when done properly, it has been disseminated far and wide without adequate precautions, training and caveats. Many people have been hurt because of the overuse of this technique.

(Guy Voeller, MD is a professor of surgery, University of Tennessee Health Science Center, in Memphis.)

PHIL SCHAUER, MD: As happens with many new surgical procedures with remarkable

early results, we surgeons tend to overuse the procedure and apply it too broadly. It seems like what is needed now for TAR is sufficient outcomes data to determine clear indications and contraindications. Clinial trials or registry data may help.

(Phil Schauer, MD is a professor of metabolic surgery and the director of the Bariatric and Metabolic Initiative, Pennington Biomedical Research Institute, Louisiana State University in Baton Rouge. He is the executive director of MISS.)

COLLEEN HUTCHINSON: Dr. Daes, the concept of the critical view of safety for laparo-

scopic cholecystectomy is not new and is accepted by many as resulting in avoidance of bile duct injury. This concept extended to inguinal hernia repair is newer and intriguing. Please tell us about your MISS2020 presentation and what the most critical takeaways are to surgeons who perform MIS. DR. DAES: New techniques, technologies, material and equipment have been rap-

idly integrated into minimally invasive inguinal hernia repair. Standardization remains elusive despite many areas of consensus. Social media has allowed a firsthand look into this phenomenon, with many procedures being undertaken without following proven maneuvers that reduce complications and recurrence.

A group of surgeons who are members of the International Hernia Collaboration (IHC) Facebook group proposed a list of recommendations that must be followed to attain an appropriate exposure of the myopectineal orifice before placing a mesh, regardless of the minimally invasive approach. These recommendations have been taught individually for years, and are based on studies that have shown fewer recurrences and complications. We consolidated these recommendations under the concept of the critical view of the myopectineal orifice (CV of the MPO). The term “critical view of safety,” introduced by Strasberg in 1995, is accepted as standard practice for preventing biliary duct injury during laparoscopic cholecystectomy.

The objective of the CV of the MPO concept is to standardize the procedure, facilitate teaching and evaluation of videos, reduce recurrences, prevent complications, and ultimately improve patient care. Fulfillment of some of these objectives has been observed, especially in social media, but clinical studies are needed to measure the impact of CV implementation in minimally invasive inguinal hernia repair. The steps of the CV of the MPO common to all procedures—totally extraperitoneal [TEP], transabdominal preperitoneal [TAPP], extended TEP, robotic TAPP, Phillips or IPOM—are described in the article by Daes J et al (Ann Surg 2017;266[1]:p1e-p2e).

Expert Commentary GUY VOELLER, MD: Dr. Daes is a wonderful man and surgeon, and I admire his attempt to equate hernia repair to gallbladder removal. He gives a list of “steps” that one does to perform an adequate MIS inguinal hernia repair. I don’t know if they have to be done in the order he lists them since they are “steps.” Just like there is no high level of evidence that the critical view of safety prevents bile duct injuries, there is no proof that the CV for the MPO of Fruchaud will prevent complications, reduce recurrences and do the other things that Dr. Daes details.

PHIL SCHAUER, MD: The critical view concept for laparoscopic cholecystectomy has

been shown to reduce catastrophic bile duct injuries. This concept extended to inguinal hernia repair may likewise reduce complications and improve overall outcomes. Now it’s time to study the impact!

IN THE NEWS

SEPTEMBER 2020 / GENERAL SURGERY NEWS

Taking Surgery Further: Improving Colorectal Outcomes with Technology and Technique Pre Presenter: Pr Sang W. Lee, MD, Costello Chair of Colorectal Diseases, professor and chief of colon and rectal surgery, Keck School of Medicine, U Un University of Southern California, Los Angeles

(Dr. Lee’s presentation was sponsored by Medtronic.)

COLLEEN HUTCHINSON: Dr. Lee, how might the newer platforms of indocyanine green (ICG) fluorescence imaging improve colorectal surgery outcomes?

outcomes for our patients and reduce health care costs in the future.

(Bradley Davis, MD is the chief of colorectal surgery at Atrium Health in Charlotte, N.C.) PHIL SCHAUER, MD: Indocyanine green

Anastomotic leakage after colorectal resection is one of the most devastating complications. Recent studies show consistently high leak rates (3%-15%). Morbidity associated with major leakage is high, and only 40% of the patients who survive go on to have stomas reversed. The economic burden of anastomotic leakage after colorectal surgery is significant. According to a recent study, anastomotic leak increases the index hospitalization cost by an average of $31,000 per patient.

Ischemia at the anastomosis is one of the major contributing factors that leads to anastomotic leakage. Indocyanine green (ICG) fluorescence imaging has shown to be more effective than clinical evaluation of tissue blood perfusion. It appears to have significant impact on reducing anastomotic leakage and may decrease severity of leak when it does occur.

Newer ICG platforms allow real-time quantitative measurements of fluorescence intensity. Its application in patients undergoing mastectomy has shown to be useful in predicting flap viability. The use of the same technology in colorectal surgery patients may allow us to objectively assess tissue perfusion at the anastomosis and prevent anastomotic leakage.

DR. LEE:

Expert Commentary BRADLEY DAVIS, MD: Anastomotic leak

remains a devastating complication for patients, as Dr. Lee points out—mortality and morbidity remain too high despite the advances in management.

Assessment of perfusion is a critical component of performing a perfect anastomosis, and historically could be evaluated by demonstrating pulsatile blood flow in the marginal vessels. As more and more of our procedures are being done with no direct ability to palpate the bowel (ie, robotic and laparoscopic intracorporeal anastomosis), and with obesity and visceral fat obscuring a surgeon’s ability to visualize these structures, adjuncts such as ICG fluorescence offer an effective alternative.

We will need more data and experience to understand the technology’s impact on rates of anastomotic leak. But with more and more MIS platforms incorporating this technology, it could improve

fluorescence imaging for assessing

tissue blood perfusion is a promising technology that may help reduce rates of colorectal anastomotic leakage. What we need is a randomized controlled trial to prove or disprove it.

With leak rates in the 3% to 15% range, such a study is feasible and should not be excessive in cost. Until then, we can only say it is promising.

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In complex hernia repair, patient risk factors and postoperative wound complications can contribute to the peril of hernia recurrence

In a recent retrospective evaluation of biologic meshes,

S T R A T T I C E™ R T M,

A 100% BIOLOGIC MESH, IS A DURABLE SOLUTION for abdominal wall reconstruction based on the long-term outcomes of low hernia recurrence rates across multiple published clinical studies1-5

91.7%

of patients were

RECURRENCE-FREE AT

7 YEARS post-op1,*

*Includes porcine and bovine acellular dermal matrices (ADMs) (n = 157) 5 .

Bridged repair and human ADM were excluded from the study group.

TO LEARN MORE ABOUT STRATTICE™ RTM, SPEAK TO YOUR ALLERGAN REPRESENTATIVE INDICATIONS STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures.

These products are supplied sterile and are intended for single patient one-time use only.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient.

This increases risk of patient-to-patient contamination and subsequent infection.

For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/ benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.

Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize

contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.

For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.

For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.

STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.

For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

For more information, please call Allergan Customer Service at 1.800.367.5737, or visit www.StratticeTissueMatrix.com/hcp.

References: 1. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350. 2. Golla D, Russo CC. Outcomes following placement of non-cross-linked porcine-derived acellular dermal matrix in complex ventral hernia repair. Int Surg. 2014;99(3):235-240. 3. Liang MK, Berger RL, Nguyen MT, Hicks SC, Li LT, Leong M. Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture in complicated open ventral hernia repair. Surg Infect (Larchmt). 2014;15(5):506-512. 4. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J Am Coll Surg. 2013;217(6):999-1009. 5. Richmond B, Ubert A, Judhan R, et al. Component separation with porcine acellular dermal reinforcement is superior to traditional bridged mesh repairs in the open repair of significant midline ventral hernia defects. Am Surg. 2014;80(8):725-731.

Allergan® and its design are trademarks of Allergan, Inc. STRATTICE™ and its design are trademarks of LifeCell Corporation, an Allergan affiliate. © 2020 Allergan. All rights reserved. STM134734 03/20

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IN MEMORIAM

GENERAL SURGERY NEWS / SEPTEMBER 2020

Morris Franklin, MD: Surgical Visionary, Teacher continued from page 1

during a career that spanned more than a half-century.

He was an early proponent of laparoscopy, touting its advantages in journal club talks to residents in the late 1980s.

He was integral to the development and adoption of laparoscopic techniques over the next three decades, particularly for the treatment of cancer. During his career, the sixth-generation Texan coauthored more than 125 papers, including landmark publications on advanced laparoscopic techniques and surgical training.

“He had a vision of the future of surgery, and he changed surgery first in San Antonio, then in south Texas and then across the globe,” said Ronald M. Stewart, a professor of surgery at the University of Texas at San Antonio. He spoke during an online memorial hosted by the Society of American Gastrointestinal and Endoscopic Surgeons during its annual meeting.

A member of 21 surgical societies, Dr. Franklin taught courses around the world and delivered more than 420 scientific presentations since 1990, but never presented without his trademark jacket and tie. He trained hundreds of surgeons throughout his career, both in and outside the United States, and many as interns at his Texas Endosurgery Institute. Many of his former trainees now teach at medical schools around the world.

He earned a reputation as masterful in the operating room, intent on finding ways to perform surgery safely and minimally invasively.

“In surgery, he was one of the highest expressions of the miracle of the human hands at work,” said long-time friend Alessio Pigazzi, MD, PhD, a surgeon at the University of California, Irvine. “He taught us that it is indeed possible to do more, a lot more with less.”

Dr. Pigazzi, together with many of Dr. Franklin’s friends and family, spoke at the online memorial. More than 150 surgeons and representatives from industry joined in, sharing stories of a man who was humble, funny and generous with his time and knowledge.

The great-great-grandson of one of the earliest doctors in Texas’ Bexar County, Morris Franklin Jr. was born Aug. 10, 1942, in Fort Worth and grew up in the small town of Poteet, where he developed a lifelong love of mechanics and farming. In 1963, he entered UT Southwestern Medical School in Dallas. There, as a first-year student, he witnessed then-President John F. Kennedy brought into the emergency department, minutes after being shot at Dealey Plaza.

“When a doctor’s medical career starts with such a tragedy, it no doubt weakens one’s spirit or hardens one’s resolve. Morris took the latter path,” his son Morris Franklin III said in a video played during the service.

After finishing his general surgery training at Robert B. Green Hospital, now the University of Texas Medical School, Dr. Franklin served with the U.S. Army’s 67th Evac in Pleiku, Vietnam. On his first day, he repaired three

of the unit’s nonfunctioning jeeps so he could use them to visit nearby communities and tend to the injured.

After returning to the United States, Dr. Franklin worked in Fort Collins, Colo., before moving to a practice in San Antonio. His career as a surgeon transformed when he and his colleagues Dr. Bill Schussler and Dr. Joe Tippett attended an out-of-state seminar on laparoscopy. With them, he developed new minimally invasive techniques and,

working closely with surgical equipment companies, new devices.

“His fingerprints are all over this industry,” said Dan Volz, the vice president, Americas at Medtronic, who worked with Dr. Franklin for two decades.

Known as an innovator who looked for new solutions to old problems, in the late 1980s Dr. Franklin modified surgical instruments to try to optimize them for laparoscopic surgery.

“Imagination was a very important

S

8

L I

IN MEMORIAM

‘In surgery, he was one of the highest expressions of the miracle of the human hands at work.’

—Alessio Pigazzi, MD, PhD

Dr. Morris Franklin’s career spanned more than a half-century, during which time he earned a reputation as a master in the operating room, intent on finding ways to perform surgery safely and minimally invasively.

part of being a surgeon for him,” said Eduardo Parra-Davila, MD, a colorectal surgeon in West Palm Beach, Fla., who trained as a fellow with Dr. Franklin.

“I was really shocked when I started to watch him do surgery. What are you supposed to think when someone changes the surgery rules that you have been taught for the past seven years in residency and fellowship?” Dr. Parra-Davila said. “He really changed the paradigm.”

During his fellowship, Dr. ParraDavila’s funding was cut and he secretly began sleeping in surgical offices at night after losing his housing. Dr. Franklin discovered him there early one morning and set him up in an apartment that night, Dr. Parra-Davila told the memorial service.

In 1997, Dr. Franklin suffered a heart attack. One of his residents, Jorge Balli, MD, now a general surgeon in Monterrey, Mexico, recalled that as Dr. Franklin lay on a stretcher waiting for air transfer on the hospital helipad, the surgeon removed his own oxygen mask and gave orders for his patients to the residents around him. “As a novice surgeon, this event was etched on my mind deeply, giving me understanding of the great humanity and medical prowess that [he] possessed,” Dr. Balli said.

Over the decades, Dr. Franklin welcomed many colleagues to his ranch in Texas, where he kept his growing collection of older cars. His love for the Rolls Royce was such that he once convinced a surgical rep to meet him in Virginia at a Rolls Royce convention and lend him a flexible endoscope so Dr. Franklin could examine the pistons of an engine.

Dr. Franklin served as a clinical professor of surgery at the San Antonio University of Texas Medical School.

Dr. Franklin’s long-time partner, Cindy Seltzer, said he always believed people should work hard and play hard, but he tended to be drawn into the former. On his last working day, he operated at 7:30 in the morning and saw 16 to 18 patients that afternoon, she said.

He is survived by Ms. Seltzer; his son, daughter-in-law Dr. Anna Franklin, and their children; his former wife, Linda Franklin; as well as numerous relatives, friends and colleagues throughout the world.

Dr. Franklin often quoted Sir Henry Royce of Rolls Royce fame in his talks.

“Take the best that exists and make it better,” he liked to say. “When it doesn’t ■ exist, design it.”

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THE SURGICAL PAUSE

GENERAL SURGERY NEWS / SEPTEMBER 2020

The Final Chapter

By MELISSA RED HOFFMAN, MD

T

he first time I saw a death certificate, I was 19 years old. The cause of death was listed as “laceration of the trachea and esophagus, also laceration of heart and lungs with fractures and bleeding caused by two gun shots in the neck and chest.”

The death certificate belonged to my father, killed by a terrorist while on a business trip in Cairo. By the time I laid eyes on it, the certificate only served to confirm a very painful truth: My father’s story had come to a very tragic and bloody end.

It’s 26 years later and I’ve managed to use this tragedy to inspire a career focused on both trauma and hospice and palliative medicine. In the simplest terms, I spend half my time trying to save lives and the other half trying to ensure a good death. For me, it works. But there’s no denying that my father’s legacy is always lingering in the background, whether I am in the trauma bay or at a patient’s bedside. The cause of death imprinted on that death certificate, along with the fear, pain and suffering that I assume it caused my dad, and the grief, sadness and never-ending longing that it evoked within me and many members of my family, is never far from my mind.

And for reasons that I don’t fully understand, I have

reread that death certificate more times than I can count.

That being said, the first time I was actually handed a death certificate to complete, I was well into my yearlong hospice and palliative medicine fellowship, and my only response was, “What am I supposed to do with this?” Despite 10 years of training including medical school, general surgery residency and critical care fellowship, I had never seen this form in the hospital, much less received any guidance on how to complete it. My hospice attending provided some cursory instruction and assured me she was available if I had questions, and that was that.

Since then, I’ve filled out more than 100 of these forms; when I work as a hospice attending, it’s not unusual for me to fill out a half-dozen death certificates during an eight-hour shift. The CDC publishes a free guide ( www.cdc.gov/nchs/data/misc/hb_me.pdf ) that has proven to be helpful to me as I’ve attempted to correctly determine and report the cause of death. State medical boards stress that physicians should exercise their best clinical judgment when filling out the form and that lawsuits involving death certificates are exceedingly rare, but I still sometimes find it nerve-wracking to determine the exact steps that led to a patient’s ultimate demise. While completing a death certificate presents an intellectual challenge and demands a short, but not insignificant, time commitment, I have recently

A Surgeon and His Art

“Valley Green in Springtime,” a watercolor by Gerald Marks, MD The Inn and restaurant at Valley Green on the Wissahickon Creek with its forest setting, bridle paths and hiking trails has a rich several-century history. Beginning in Revolutionary times as an important industrial center with multipurpose mills, the Creek and Valley have become a favorite of Philadelphia hikers, equestrians, fishermen, birdwatchers and particularly photographers and painters. After a long-held yearning to paint the Inn, I finally yielded.

Issues in Surgical Palliative Care come to view the process as something more profound than another item on my to-do list. Because this form is required for both burial and cremation, I now regard it as both the final chapter of a patient’s life story and the first chapter of a family’s bereavement narrative.

As a surgeon trained in hospice and palliative medicine, my personal narrative has changed from ‘There’s nothing more I can do’ to ‘Let me walk with you.’ Taking the time to complete a death certificate is another way for me, and all surgeons, to follow a patient’s story to the very end.

I often think of my father when filling out these forms and it always gives me pause. When I open the medical record, I’m usually touched by the thought that I’m very likely the last physician who will ever study this information. Reading through the chart, I like to linger for a moment or two and think: Who was this patient?

What did he do for work? Who did she love, and, just as importantly, who loved her? I also find myself wondering what happened. What, if anything, could we have done differently or better? Could we have caused less suffering? Provided more comfort? Consulted palliative care earlier or at all?

Last week, while I was working at the local inpatient hospice facility, a female patient, five years younger than me and recently diagnosed with metastatic cancer, died before I had the opportunity to round on her. When I went to view her body, I was struck by the stark difference between the glowing, robust woman pictured in a photo hanging above her bed and the bald, gaunt corpse lying curled up on her side. “She truly had nothing left to give,” I commented to the nurse and the chaplain as they gathered her few belongings to return to her family. As I was getting ready to leave for the day, the funeral director arrived to collect her body and asked if I had a few minutes to complete her death certificate. I knew almost nothing about this woman—she had been under my care for only a few short hours—and yet I was tasked, and blessed, with signing off on the final chapter of her life. With this last act of patient care, I was able to support her family in the first steps along their grief journey.

As a surgeon trained in hospice and palliative medicine, my personal narrative has changed from “There’s nothing more I can do” to “Let me walk with you.” Taking the time to complete a death certificate is another way for me, and all surgeons, to follow a patient’s story ■ to the very end.

—Dr. Hoffman is an acute care surgeon and a hospice attending in Asheville, N.C. To listen to the latest installment of her podcast on surgical palliative care, go to https://apple.co/33H6s5w.

IN THE NEWS

SEPTEMBER 2020 / GENERAL SURGERY NEWS

Novel Technique Could Minimize COVID-19 Risk During Tracheostomy

By NAVEED SALEH, MD, MS

S

urgeons at Berkshire Medical Center developed a novel barrier to potentially decrease the risk for COVID-19 transmission during tracheostomy. Details were published in a recent issue of the Journal of American College of Surgeons (2020; 230[6]:1102-1104).

“In addition to all the PPE gear, we wanted to create a means to contain COVID-19 as much as possible to minimize exposure,” said Michael DiSiena, DO, the lead author and a surgeon at Berkshire Medical Center, in Pittsfield, Mass.

Dr. DiSiena said the technique is functional and easy to assemble, and it could be useful for other operations that entail aerosolization risk or droplet exposure to OR personnel.

“We used a table retractor, a device called the Omni-Tract [Integra Lifesciences],” he said. “It allowed us to create a frame, … a plastic barrier similar to a tent, that allowed us to minimize respiratory secretions from being expelled from the trachea when you perform the tracheostomy.

“If the patient has COVID-19 and you perform a tracheostomy, a gush of air is released, and that air can obviously contain respiratory droplets and viruses,” Dr. DiSiena said. “So, we developed almost a sterile tent that allowed us to see through the clear plastic drape, which is sterile. We could put our hands underneath this tent and work in an operative field.”

To further minimize the risk for contamination due to aerosolization, the team used a novel filtration system.

“We then used a suction apparatus that allowed us to evacuate the air so it would be filtered almost like an N95 mask filter system,” Dr. DiSiena added.

The team also used a simple, yet novel method for testing this filtration system.

While testing the air to detect respiratory droplets was outside the capabilities of their institution, the team lit a cigarette and had a smoker on staff take a puff in the field to test whether the smoke cleared. “We could not detect the cigarette smoke,” Dr. DiSiena said.

Nevertheless, Dr. DiSiena readily acknowledges that the technique lacks experimental validation. “We do not have any experimental data to prove the efficacy of it, but intuitively it seems to work out well,” he said. “Whether it ultimately translates into decreased exposure, I am unsure.”

To date, the staff at Berkshire Medical Center has employed the novel tracheostomy technique on two COVID-19 patients with positive outcomes. Dr.

DiSiena also explained that the intervention requires approximately five to eight minutes of setup, and it did not render surgery unsafe in any way.

Looking forward, Dr. DiSiena anticipates that other surgeons and anesthesiologists could adopt the technique for improved safety. “We felt we came up with a great idea. We wanted to promote this technique as soon as possible given the crisis, and allow others to adapt to the technique, modify or improve upon

it.” He also hopes that industry could use the idea to develop a commercial product with greater applicability.

In a separate interview, Jingping Wang, MD, PhD, an associate professor in the Department of Anesthesia, Critical Care and Pain Medicine at Massachusetts General Hospital, in Boston, provided his perspective.

“This instrument can be used as a physical shield, like wearing a mask. But we don’t know whether it functions like

a surgical mask or N95 mask,” he said.

“It may or may not be a source of control for aerosols, unless supported by a validation test. Ideally, a device should be developed to function as not only a physical barrier but also a source of control for aerosol transmission, without interrupting surgery,” Dr. Wang said. We need better-designed devices to meet our clinical demands, not only in the OR but also in the ICU, ED, on the floor and ■ during patient transportation.”

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IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2020

Pandemic Fuels Explosion in PPE and Tech Innovation

By ALISON McCOOK

S

omething was happening.

Nearly 20 years ago, David Bray, PhD, was working as the information technology chief for the CDC’s Bioterrorism Preparedness and Response Program, when he noticed a strange anomaly: In China, the price of garlic had risen nearly 10-fold. Since garlic is considered medicinal by many people in China, Dr. Bray and his team knew

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Limitation of Use: Safety and efficacy has not been established in other nerve blocks.

CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death.

WARNINGS AND PRECAUTIONS Warnings and Precautions Specific for EXPAREL As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity.

Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products.

Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration.

• epidural • intrathecal • regional nerve blocks other than interscalene brachial plexus nerve block • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups.

• patients younger than 18 years old • pregnant patients The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days as seen in clinical trials.

ADVERSE REACTIONS Clinical Trial Experience Adverse Reactions Reported in Local Infiltration Clinical Studies The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

Adverse Reactions Reported in Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebocontrolled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, post-procedural hematoma.

Postmarketing Experience These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest).

DRUG INTERACTIONS The toxic effects of local anesthetics are additive and their co-administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic cyclophosphamide, flutamide, hydroxyurea, ifosfamide, agents rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Bupivacaine Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

Non-bupivacaine Local Anesthetics EXPAREL should not be admixed with local anesthetics other than bupivacaine.

Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL.

something had to be amiss. Working with people on the ground, they learned the country was experiencing a wave of an atypical febrile illness. Months later, China revealed it had been struck by a new coronavirus, SARS-CoV-1, also known as severe acute respiratory syndrome (SARS). “We knew about it five and a half months before the Chinese government said anything,” Dr. Bray said.

Today, as the world reels from the

Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration.

Water and Hypotonic Agents Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia.

While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death.

Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.

Data Animal Data Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate).

Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/kg/day (equivalent to 0.1, 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight). No embryo-fetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity.

Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) from implantation through weaning (during pregnancy and lactation).

Lactation Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Of the total number of patients in the EXPAREL local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. Of the total number of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients were greater than or equal to 65 years of age and 60 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver.

Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider increased monitoring for local anesthetic systemic toxicity in subjects with moderate to severe hepatic disease.

Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing dose selection of EXPAREL. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution.

Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, dizziness, dysarthria, confusion, mental obtundation, sensory and visual disturbances and eventually convulsions) and cardiovascular effects (that range from hypertension and tachycardia to myocardial depression, hypotension, bradycardia and asystole).

Plasma levels of bupivacaine associated with toxicity can vary. Although concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have been reported at levels as low as 800 ng/mL. Management of Local Anesthetic Overdose At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of anesthetics, with these anticonvulsant drugs. Supportive treatment of

effects of another novel coronavirus, SARS-CoV-2 (COVID-19), Dr. Bray has been tracking innovations that rely on more than just garlic prices to quickly spot outbreaks, such as low-cost tools that analyze viral levels in wastewater.

Other exciting developments that could help protect from and prevent future pandemics include medical devices that use artificial intelligence to guide treatment decisions and “smart” personal protective

circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, maybe indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

DOSAGE AND ADMINISTRATION Important Dosage and Administration Information • EXPAREL is intended for single-dose administration only.

• Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL. • DO NOT dilute EXPAREL with water for injection or other hypotonic agents, as it will result in disruption of the liposomal particles.

• Use suspensions of EXPAREL diluted with preservative-free normal (0.9%) saline for injection or lactated Ringer’s solution within 4 hours of preparation in a syringe.

• Do not administer EXPAREL if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period.

• Inspect EXPAREL visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer EXPAREL if the product is discolored.

Recommended Dosing in Adults Local Analgesia via Infiltration The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266mg (20 mL), and is based on the following factors: • Size of the surgical site • Volume required to cover the area • Individual patient factors that may impact the safety of an amide local anesthetic As general guidance in selecting the proper dosing, two examples of infiltration dosing are provided: • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL was administered with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue.

• In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block.

Regional Analgesia via Interscalene Brachial Plexus Nerve Block The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair.

Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended.

• Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more.

• Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

• When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy.

PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA Patent Numbers: 6,132,766 5,891,467 5,766,627 8,182,835 Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only November 2018

There is no end to what computer learning can do to help during a pandemic. equipment (PPE). The possibilties are endless, said Dr. Bray, now the director of the Atlantic Council GeoTech Center, a think tank based in Washington, D.C. The pandemic is forcing innovators to work hard—and quickly, Dr. Bray said.

Most of the new ideas he encounters are one to three years away, “if not already here,” he told General Surgery News.

“Things will change. We won’t go back to ‘normal.’”

New Ideas for a New World To get a sense of what’s happening, the Atlantic Council recently surveyed more than 100 technology experts regarding their predictions of the effect of COVID-19 on innovation. Not surprisingly, respondents agreed that the pandemic will significantly accelerate innovation in data and AI, as well as the medical and bioengineering fields.

Examples already abound. Recently, M-Sparc, a science park in Wales, held a “Hack COVID-19” event, in which it challenged innovators to find new ways to help patients; one winner developed a microphone that lets surgeons and other health care workers hear better when wearing FFP3 masks. Another creation was a hands-free door opener for hospital settings, which the designer has made free to anyone with a 3D printer.

And when it comes to PPE, the future is smart—smart garments specifically, which transmit information about the environment or the clothing itself. Such clothing may adjust the temperature in response to outward conditions, emit light in the dark, or even alert wearers of environmental dangers. Further, smart shoes could alert workers when someone is approaching, so they can don a mask.

Other innovators are focusing on improving the materials themselves, such as Canadian company Texavie, which is developing PPE with interwoven antiviral and antibacterial biocides for superior

IN THE NEWS

SEPTEMBER 2020 / GENERAL SURGERY NEWS

protection. Protection works best when it has a personalized fit, said Dr. Bray, so future garments may scan or use photos to produce something on demand that’s tailored to the specific wearer.

Some COVID-19– inspired innovations involve tweaks to existing tools to fit the needs of a new world. For instance, the “smart mirror” Miaza Mirror—meant to display email and news—now plays an animated video about proper handwashing. Makers of the Ava bracelet are claiming it can both track ovulation and alert users to the early signs of COVID-19 via changes in breathing rate, pulse rate and skin temperature. Drones are being used to broadcast public health messages about social distancing, as well as monitor fevers and spray streets with sanitizers.

One company that Atlantic has partnered with, Valence Medical, is tackling supply chain logjams, such as when pandemic-hit nations scramble for PPE and other supplies. The technology would create a virtual middleman that links reliable suppliers to reliable buyers, sorts out fair pricing, and facilitates the monetary transaction. Another Atlantic partner is applying computer vision to the manufacturing process, to ensure that items produced from different manufacturers have similar quality. The technology was originally expected in 10 to 15 years, but the pandemic has significantly accelerated the time line, Dr. Bray noted.

AI to the Rescue There is no end to what computer learning can do to help during a pandemic: AI can sift through the mass of research pouring in about COVID19 and identify promising areas to pursue, accelerate the discovery of therapies that block the virus, identify early warning signs of new outbreaks, and provide insight about when it’s safe to return to work and school. Other benefits include identifying new risk factors for severe disease, such as genetic markers or blood types, which can guide resource distribution, said Stewart Scott, a program assistant with Atlantic.

One such device that uses AI to monitor patients—including, most recently, those diagnosed with COVID-19—is Emerald, a wireless system developed by a team led by Dina Katabi, PhD, the Andrew and Erna Viterbi Professor of Electrical Engineering and Computer Science at Massachusetts Institute of Technology, in Cambridge. The device passively monitors patients’ vital signs, activity, sleep quality/stages and respiration, and then transmits that information

to their health care providers. It does so by analyzing the wireless signals in the room without any physical contact with the patient’s body. Since it’s already been tested in a variety of diseases such as Alzheimer’s and Parkinson’s (Digit Biomark 2019;3:22-30), “when COVID-19 became the problem, the Emerald was just a natural fit,” Dr. Katabi told General Surgery News.

The company Dr. Katabi co-founded is now collaborating with Mayo Clinic, McLean Hospital and Washington University School of Medicine in St. Louis.

“By having these records of the evolution

of symptoms of different patients, one could develop machine learning models to predict the risk that a particular patient may experience a difficult recovery journey,” she said. “Retrospective analysis of this data along with patients’ medical history could be useful in guiding hospital admission and discharge decisions.”

Necessity is the mother of invention, and right now, COVID-19 has created the need for tools to treat the current pandemic and mitigate the effects of future outbreaks, Dr. Bray said. The situation reminds him of how the risk from house fires prompted innovators

to design a system to warn occupants before it was too late. “Can we instrument the planet in such a way that we’ll have earlier warning signs about new viruses and infections, analogous to ■ smoke detectors?”

Disclosures: Dr. Katabi co-founded the company behind the Emerald device; the Atlantic Council GeoTech Center is partnered with two companies in the medical industry; one is Nanotronics and another is SICPA, a Swiss company involved with the economy of trust in medical supply chains.

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Impact Factor: Recent Studies in Colorectal, Hernia Surgery Determining Timing of Safe Discharge for Colorectal Surgery Patients ournal Watch, a regularly occurring column in General Surgery News, hopes to provide readers with a quick review of recent journal articles that may be relevant to the scope of a general surgeon’s practice, a discussion of the salient limitations, and pertinent related articles that may be worthwhile on the same topic. How do you decide whether a surgical journal is worth your while to read? How do you decide whether the evidence and article are reliable or not?

With a plethora of surgical journals available to readers, it can sometimes be overwhelming to find useful, reliable articles to help guide changes in practice.

Journal Impact Factor indexed in the Journal Citation Reports is not a perfect metric, but often is used as a surrogate for the influence a journal has on the scientific community. It is calculated by dividing the number of citations from the current year by the total number of articles published in that journal during the prior two years. With the most recent journal impact factors, JAMA Surgery (13.625), Annals of Surgery (10.130), and the British Journal of Surgery (5.676) have the three highest impact factors in the field of general surgery. For this installment of Journal Watch, we review an article from each of these journals.

J

—Arielle Perez, MD, MPH, MS Director of UNC Health Hernia Center and Assistant Professor of Surgery in the Division of General, Acute Care, and Trauma at The University of North Carolina at Chapel Hill School of Medicine

Column Editor

Article Title

Journal

Study Design

Safety of hospital discharge before return of bowel function after elective colorectal surgery

Br Surg.

2020;107(5): 552-559

Prospective multicenter cohort study

In the British Journal of Surgery, The EuroSurg Collaborative published an analysis of its prospective multicenter cohort study evaluating discharge criteria for elective colorectal surgery patients (Br J Surg 2020;107[5]:552-559). It should be noted that this was a planned additional study using the same patient population from the IMAGINE study, evaluating the safety and efficacy of nonsteroidal antiinflammatory drugs (NSAIDs) to reduce ileus after colorectal surgery (Table; Related Articles).

The authors included any patients undergoing transabdominal elective colorectal surgery (open and minimally invasive) at secondary and tertiary care hospitals in Europe, Australasia and South Africa. Patients with a hospital length of stay or no return of bowel function (ROBF) for more than 10 days were excluded, as the authors assumed they had an atypical hospital course. In total, 3,288 patients from 385 hospitals in 27 countries were analyzed with 301 patients (9.2%) discharged before they had full ROBF, defined as tolerating solid food and passing stool, and 2,987 (90.8%) discharged only after full ROBF. Patients discharged prior to ROBF were: • less likely to have had prior abdominal surgery (33.6% vs. 40.2%; P=0.026) or have a preexisting stoma (2.7% vs. 6.1%; P=0.041); • more likely to be treated at a hospital with higher enhanced recovery after surgery (ERAS) compliance (38.4% vs. 27.4%; P>0.001); • more likely to have had minimally invasive surgery (68.8% vs. 63.8%; P=0.005) or a right colon resection (51.8% vs. 37.9%; P<0.001); Key Takeaways

• Discharge before full return of bowel function (tolerating a solid diet and having bowel movements) can be done safely in appropriately chosen patients.

• Open surgery, a new ileostomy and diabetes increase the likelihood of readmission after elective colon surgery.

Colorectal surgical site infection prevention kits prior to elective colectomy improve outcomes

Ann Surg.

2020;271(6): 1110-1115

Robotic inguinal vs transabdominal laparoscopic inguinal hernia repair: the RIVAL randomized clinical trial

JAMA Surg.

2020;155(5): 380-387

Retrospective review with propensitymatched analysis

• Patient compliance with preoperative antibiotics and bowel preparation were significantly increased with receipt of the free kit.

Randomized controlled trial

• No difference in patient-reported outcomes of mobility, postoperative pain and quality of life

• Reduction in postoperative ileus, any SSI, anastomotic leak, unplanned reintubation, hospital length of stay and unplanned readmission in patients who had received the free prevention kit

• Overall cost using the robotic platform was higher than laparoscopic.

• Surgeon levels of frustration, ergonomics and effort were all worse with the robotic platform.

• less likely to have had a new stoma created (10.3% vs. 26%; P<0.001); • less likely to have an epidural placed (10.3% vs.

17.3%; P=0.001) or require a blood transfusion (2.3% vs. 6.4%; P=0.003); • and more likely to have had a wound catheter for analgesia (7.6% vs. 4.3%; P=0.014).

The median hospital length of stay for patients discharged prior to ROBF was five days (range, four to seven days), compared with seven days (range. six to eight) for patients discharged only after full ROBF (P<0.001). The rate of readmission within 30 days was similar in both groups (6.6% vs.

8.0%; P=0.499), but readmission was more likely in patients who were diabetic, having an open operation or receiving a new ileostomy, or receiving IV patient-controlled analgesia. There were no statistically significant differences in postoperative complications, including anastomotic leak and acute kidney injury, in patients discharged before or after ROBF. The authors provide very useful information to assist in determining timing of safe discharge.

This study adds to evidence by Ellis (Table; Related Articles) that discharge before full ROBF is safe in elective colorectal surgery patients, and provides additional information on risk factors, such as diabetes, an open surgery or a new ileostomy, of patients who are more likely to be readmitted and may benefit from closer monitoring and/or increased education before discharge. Discharges before ROBF were seen more commonly with the use of a robust ERAS pathway and a minimally invasive surgical approach, an observation in line with evidence published by Lawrence et al demonstrating safe discharge for colorectal surgery patients using an enhanced recovery pathway in conjunction with a laparoscopic approach (Table;

Study Limitations • Study design does not allow for enhanced recovery after surgery (ERAS) pathway and postoperative management factors to be assessed.

• Potential selection bias, with discharge based on clinician judgment instead of studydefined criteria • Unable to determine which intervention(s) in the bundle have a positive effect

Useful Related Articles EuroSurg Collaborative. Br J Surg.

2020;107(2):e161-e169.

Ellis CN. Am J Surg. 2017;213(3):544-547.

Fiore JF Jr, Bialocerkowski A, Browning L, et al. Dis Colon Rectum. 2012;55(4):416-423.

Lawrence JK, Keller DS, Samia H, et al.

J Am Coll Surg. 2013;216(3):390-394.

Carmichael JC, Keller DS, Baldini G, et al.

Dis Colon Rectum. 2017;60(8):761-784.

• As a quality improvement study over time, there are possible confounding factors that could contribute to improved outcomes.

• Study design was limited to unilateral inguinal hernias in the setting of no prior intraabdominal surgery.

• Baseline surgeon proficiency on the robotic platform is unknown.

HerniaSurge Group. Hernia. 2018;22(1):1-165.

Charles EJ, Mehaffey JH, Tache-Leon CA, et al. Surg Endosc. 2018;32(4):2131-2136.

Abdelmoaty WF, Dunst CM, Neighorn C, et al. Surg Endosc. 2019;33(10):3436-3443.

Trevisonno M, Kaneva P, Watanabe Y, et al.

Hernia. 2015;19(5):719-724.

JOURNAL WATCH

SEPTEMBER 2020 / GENERAL SURGERY NEWS

Related Articles). With a large study population across multiple hospitals and countries, there is wide variation in ERAS pathways and postoperative patient management that are potential confounding factors unaccounted for in this study. No defined discharge criteria were outlined in this study. Instead, discharge was based on clinical judgment, leading to potential selection bias and may skew observed readmission rates and characteristics of early discharge.

Lastly, it should be noted this patient population from the IMAGINE study had no added intervention from normal perioperative care for elective colorectal surgery, but rather it was an assessment of the safety and efficacy of NSAIDs, in which the authors concluded NSAID use did not reduce ileus but did reduce postoperative opioid requirements. With ileus occurring in up to 20% of all patients undergoing elective colon resection, this study helps to define patient and surgical characteristics that are associated with a safe discharge prior to ROBF.

Inexpensive Kit Increases Post-op Compliance in Colectomy Patients In Annals of Surgery, Deery et al published results of a quality improvement project at Massachusetts General Hospital (Ann Surg 2020;271[6]:1110-1115). In an effort to standardize preoperative practices among surgeons and to increase patient compliance, a surgical site infection prevention kit (SSIPK)—costing the institution approximately $34, but supplied free of charge to all patients undergoing elective colectomy—included an educational handout, chlorhexidine body wash, oral antibiotics, mechanical bowel preparation and a carbohydrate-rich nutritional supplement. Links to informational videos, in a variety of languages, were also provided.

In the study, American College of Surgeons National Surgical Quality Improvement Program institutional data on elective colectomy patients from January 2013 through March 2017 were stratified into two groups: 221 patients (11.2%) who received the SSIPK (SSIPK+) and 1,760 patients (88.8%) who did not (SSIPK‒). To create comparable groups in which preoperative characteristics were not statistically different, the authors used statistical techniques to match the SSIPK+ and SSIPK‒ patients, 1:1, by their propensity score. After matching, there was a significantly higher rate of documented preoperative mechanical bowel preparation (95% vs. 71%; P<0.001) and oral antibiotic use (94% vs. 27%; P<0.001) in the SSIPK+ group along with a shorter operating time. The wound classifications and case type (open vs. laparoscopic vs. robotic vs. hybrid) were similar in the two groups. Outcomes at 30 days between the two groups showed no difference in postoperative death, but in the SSIPK+ group there were lower rates of postoperative ileus (5.9% vs. 14.2%; P<0.01), any surgical site infection (5.9% vs. 11.4%; P=0.04), anastomotic leak (2.7% vs. 6.8%; P=0.04), and unplanned reintubation (0% vs. 2.3%; P=0.02), as well as a shorter hospital length of stay (3.8 vs. 5.2 days; P<0.01) and fewer unplanned readmissions (5.9% vs.

14.6%; P<0.01).

In this article, the authors described an easy solution to increase patient compliance and reduce patient complications. By using guidelines from both the American Society of Colon and Rectal Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons (Table; Related Articles), the multidisciplinary team employed best practices to enhance an already adopted ERAS pathway. Recommendations for preoperative

mechanical bowel preparation with oral antibiotics, preoperative nutritional enhancement and a perioperative surgical site infection (SSI) bundle, such as a preoperative chlorhexidine shower, were implemented with the SSIPK in hopes of reducing complications. The institution should be lauded for creating this quality improvement project.

Although there is an up-front cost to making and distributing the kits, it can be assumed to be offset by the reduction in costs that otherwise would arise from complications and longer hospital stays. As a bundle, it is difficult to determine if there is one intervention that is more critical than another—the educational handout, additional instructional videos, ease of the patient in obtaining all items, etc. As a quality improvement project over time, with ever-continuing changes to ERAS protocols and varying methods of postoperative patient management, there are many confounding factors, such as new pain control regimens or differing postoperative management styles by clinicians, that also can contribute to some of the noted improved outcomes. Ideally, this would have been conducted as a randomized controlled trial to evaluate whether the kit increases patient compliance and reduces complications. However, as a quality improvement project, the outcomes are compelling, and this simple intervention should be considered by other institutions and surgeons.

Laparoscopy Versus RobotAssisted for Inguinal Hernia: The RIVAL Trial In JAMA Surgery, Prabhu et al published their results of the RIVAL trial, the first-ever randomized controlled trial comparing laparoscopic and robotic inguinal hernia repair techniques using a transabdominal preperitoneal (TAPP) approach (JAMA Surg 2020;155[5]:380-387). This multicenter trial took place between 2016 and 2019, with surgeons at six academic and academic-affiliated centers. Baseline practice preferences of each surgeon were not known, but all participating surgeons were fellowship-trained in minimally invasive surgery with a high-volume practice in hernia repair and had completed at least 25 laparoscopic and 25 robotic-assisted procedures prior to the study.

Inclusion criteria were patients aged 21 years and older with a primary or recurring unilateral inguinal hernia, who had no prior intraabdominal surgery at or below the umbilicus, no prior preperitoneal mesh in the ipsilateral groin, and a body mass index (BMI) of 40 kg/ m2 or lower. Of the 102 patients included in the study, hernia characteristics and baseline characteristics, other than mean BMI, were evenly distributed. Outcomes

evaluated included postoperative pain; patient mobility; wound morbidity and cosmesis; patient quality of life; cost; and surgeon ergonomics, effort and intraoperative frustration. Patient follow-up occurred at one week and one month postoperatively, with future analysis planned for one and two-year follow-up.

The laparoscopic repair was performed with a flat piece of heavy-weight polypropylene mesh fixed with a permanent tacking device, and the peritoneal flap was closed with the same device. The robotic repair, using both the Si and Xi robotic platforms (Intuitive), was carried out with the same type of mesh fixed with a permanent suture, and the peritoneum was closed with a surgeon-chosen running suture. There was no difference between the groups in postoperative mobility, pain scores, quality of life, and wound morbidity and cosmesis. The median duration of the procedure from skin incision to closure was significantly longer in the robotic-assisted group (75.5 vs. 40.5 minutes). Even when omitting docking time for the robot, discrete procedural steps including hernia dissection, mesh fixation and peritoneal flap closure, all took a longer time with the robotic-assisted repair. Surgeon ergonomics, effort and frustration were significantly worse with the robotic platform.

The RIVAL trial is the first randomized controlled trial to evaluate the utility of the robotic platform against laparoscopy for inguinal hernia repair. Like most randomized controlled trials, this undoubtedly took painstaking effort to conduct, and the authors should be commended on their efforts. The narrow patient population group of “straightforward unilateral inguinal hernias” with a mean BMI of 26.9 (laparoscopic) and 24.9 (robotic) kg/m2 excludes many patients who require further evaluation. Minimally invasive surgery in patients with a high BMI has been shown to be beneficial secondary to its lower wound morbidity and physical strain on the surgeon.

It is unclear what effect use of the robotic platform may have on obese and morbidly obese patients when compared with laparoscopy. It should be noted that one robotic case was converted to laparoscopic secondary to bleeding, suggesting the surgeon’s comfort level and skills leaned toward laparoscopy. In 2009, the European Hernia Society suggested that 50 to 100 laparoscopic inguinal hernia repairs are required to gain proficiency in the technique, and it may be that the minimum 25 robotic-assisted cases used to assume proficiency in this study may not have been sufficient. With any surgery, the operating team plays a critical role in required effort and frustration. Theoretically, robotic surgery benefits from a knowledgeable OR team for docking and exchanging instruments, whereas laparoscopic repair continued on the following page

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Mesh-Free Hernia Technique Works Well in Selected Patients continued from page 1

chronic pain and none experienced a recurrence.

“It is safe with acceptable outcomes in a very select group of low-risk patients, especially those with bilateral hernias or those who are at risk for mesh-related complications,” Dr. Towfigh said.

R-IPT is a modern adaptation of an open posterior approach tissue repair, first developed in the late 1950s by Drs. Lloyd Nyhus and Robert Condon, and later made obsolete by mesh-based totally extraperitoneal and transabdominal preperitoneal (TAPP) repairs. Dr. Towfigh studied the original repair and revised it for a robotic TAPP approach to the iliopubic tract. This repair would be very difficult to perform safely using standard laparoscopic equipment, but is feasible with the articulating instruments of the robot, she said.

A minimally invasive, suture-based technique, the r-ITP repair could address the growing demand for nonmesh repairs without the disadvantages of open surgery, according to Dr. Towfigh.

However, she and other surgeons familiar with this technique warn that it should be used in a very limited patient population and performed by experienced hernia surgeons alert to nerve anatomy. This repair may increase the risks for recurrence and/or chronic pain if performed in patients with large hernias or without meticulous attention to the nerves, said Edward Felix, MD, a private practice hernia surgeon who trained with Dr. Nyhus as he was developing the original procedure.

“The most important things that need to be discussed are who is this repair for and who’s going to do it because [of ] the risk of injuring the nerves,” Dr. Felix noted. “By putting your stitches inferiorly too deeply and superiorly too deeply, you can injure nerves.”

For the r-IPT procedure, the surgeon places the ports similarly to those used

Before and after: Figure A shows a defect through the right indirect space.

With the nerves of the triangle of pain carefully dissected, this defect is ready for suture closure. Figure B shows the same defect after suture closure of the transversalis arch to the iliopubic tract without entrapping the nerves.

for any r-TAPP repair for inguinal hernia. After the abdomen is accessed, a standard TAPP dissection is performed.

The r-IPT repair of an indirect hernia requires suturing of the transversalis arch to the iliopubic tract using nonabsorbable running sutures. Identification of the genital and femoral branches of

Journal Watch continued from page 15

requires a much more skilled first assistant to manage the laparoscopic camera. The level and consistency of the OR staff used during these cases are unclear and may play a role in affecting not only the surgical times, but the surgeon as well.

Preperitoneal dissection can be complicated by prior pelvic operations such as prostatectomy, cesarean delivery, lymph node dissections and prior preperitoneal mesh placement, and often this history is a reason for preferentially performing an open inguinal hernia repair. It is unclear whether the robotic platform demonstrates advantages in preperitoneal dissection in cases of difficult anatomy. The 2018 international guidelines for groin hernia repair published by the HerniaSurge

the genitofemoral nerve and the lateral femorocutaneous nerve is critical, the authors said, because these nerves run under or through the iliopubic tract and are at risk for injury or entrapment.

For direct inguinal hernia repair, the r-IPT involves suturing the transversalis arch to the iliopubic tract using

Group recommends “surgeons/surgical services provide both anterior and posterior approach options” and that a posterior technique (i.e., laparoscopic and robotic repair) be used for recurring inguinal hernia repairs in cases involving prior open approach, femoral hernias, female patients and bilateral inguinal hernia repairs, provided that expertise and resources are available (Table; Related Articles).

As of 2015, 46% of surgeons provide only an open approach to inguinal hernia repair. It is unclear whether gaining proficiency in a posterior approach to inguinal hernia repair may be more easily facilitated with either a laparoscopic or robotic platform. Findings showed that robotic repair costs were higher in all categories— total cost, OR cost and variable material cost—echoing studies by Charles et al and Abdelmoaty et al that have found higher overall costs with robotic repair (Table;

nonabsorbable stitches, after identifying the tract separate from Cooper’s ligament. Suturing to Cooper’s ligament will place the repair under too much tension, the authors noted.

In female patients, the surgeons recommend routine transection of the round ligament followed by closure of the internal ring.

The report in Hernia details the full operative steps to avoid injury to the nerves (doi: 10.1007/s10029-020-02259-7).

Dr. Towfigh recommends this approach for patients who cannot tolerate or do not want a mesh repair, and who have a body mass index below 30 kg/m2 and an inguinal hernia that is not bulging, or for patients with bilateral small hernias. She also performs the repair in patients who come to her to have mesh removed robotically because they’re reacting to the mesh or it’s folded, and patients with collagen disorders such as Ehlers-Danlos syndrome.

“I really don’t want this technique to fail by encouraging everyone to use it, but it’s the only minimally invasive option for a nonmesh inguinal hernia repair,” she said.

Since the results of the pilot study were submitted, Dr. Towfigh has performed the repair on more than 40 patients. A morbidly obese patient with a mediumsized inguinal hernia experienced postoperative chronic pain, likely due to the tightness of the repair.

“If it’s a larger hernia, a patient could end up tearing through the repair or they risk chronic pain because it’s too tight,” Dr. Towfigh said.

The original open repair had a 9% recurrence rate, which was why Dr. Nyhus replaced it with a mesh-based repair. Dr. Towfigh said she believes larger and recurrent inguinal hernias repaired with the r-IPT approach will have a similar fate if it is broadly applied.

A video of the repair is available online at https://youtu.be/QUGPw15vJwY. ■

Related Articles). However, it can be expected that over time, with increased surgeon proficiency, surgical team competence and strategic use of instruments on the robotic platform, OR costs and variable material costs will decrease, and may become similar to a laparoscopic case.

Based on the results of this study, using a robotic platform does not show any benefit over laparoscopy, and in fact costs more, in a very specific subset of straightforward case patients. With the increasing adoption of robotics in general surgery and hernia repair, the benefits, or lack thereof, of the robotic platform for more complicated patients, in specific settings with inadequate first assistants, for proficient robotic surgeons with short case times and precise instrument use, or for surgeons not familiar with a laparoscopic repair, still require evaluation.

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IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2020

Practice Value: Top Breast Cancer Papers Reviewed continued from page 1

of breast surgery and co-director of the Stamford Hospital Breast Center, in Connecticut.

Hair dye and chemical straightener use and breast cancer risk in a large U.S. population of black and white women Int J Cancer 2020;147(2):383-391 https://pubmed.ncbi.nlm.nih.gov/31797377/

To examine the association between the use of hair dyes and chemical straighteners and breast cancer risk, investigators evaluated findings on 46,709 of 50,884 women enrolled in the Sister Study (women with no personal history of breast cancer but at least one sister with a history of the disease). At a median follow-up of 8.3 years, 2,794 women had developed breast cancer.

Permanent hair dye use was associated with an increased risk of 9% overall to 60% in Black women who dyed their hair frequently, every five to eight weeks.

Straightener use was associated with an 18% increase in risk that rose to 31% with greater use, but did not vary by race.

“When asked directly if women should stop dyeing and straightening their hair, the authors basically said it’s up to each woman to decide her risk– benefit threshold, but if they’re really trying to do everything they can to reduce risk, avoiding hair dye and straightener is something to consider,” Dr. Pass said.

Supplemental MRI screening for women with extremely dense breast tissue N Engl J Med 2019;381(22):2091-2102 https://pubmed.ncbi.nlm.nih.gov/31774954/

To assess the effect of MRI screening on the reduction of interval breast cancers, researchers assigned 40,373

women with dense breasts to supplemental MRI screening or mammogram screening alone; 8,061 underwent MRI and 32,312 did not. The MRI-screened group had 2.5 cancers per 1,000 screenings and the mammogram-only group had five per 1,000.

“The authors concluded that supplemental MRI surveillance in this patient population reduces their risk of an interval cancer by half, but is a reduction in interval cancers an appropriate surrogate for overall survival? Also, DCIS [ductal carcinoma in situ] was 10 times more common in the MRI-screened group, making concern for overdiagnosis real, and the cost is not trivial,” Dr. Pass said.

“By itself, I’m not sure density alone warrants MRI screening, but density plus family history plus a difficult mammogram plus patient’s concern all factor in.”

MRI does not predict pathologic complete response after neoadjuvant chemotherapy for breast cancer J Surg Oncol 2019;120(6):903-910 https://pubmed.ncbi.nlm.nih.gov/31400007/

To assess whether radiological complete response (rCR), defined as the absence of any suspicious MRI findings in the ipsilateral breast or lymph nodes, can predict pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC), researchers conducted a retrospective review of 102 patients. Of the 44 patients with pCR, 12 (27%) still had some disease at the time of surgery.

“The flip side is that 27% of the 41 patients who had a pCR also had a rCR, so it seems you can’t predict it ether way.

The authors’ conclusion is the same as mine: rCR on MRI is not accurate enough to serve as a surrogate marker for pCR after NAC,” Dr. Pass said.

Is breast-conserving therapy appropriate for male breast cancer patients? A national cancer database analysis Ann Surg Oncol 2019;26(7):2144-2153 https://pubmed.ncbi.nlm.nih.gov/30761438/

To evaluate the impact of breastconserving therapy (BCT) in men, researchers conducted a retrospective analysis of 8,445 stage I and II patients.

Of those patients, 5,165 (61%) underwent total mastectomy, 1,539 (18%) received BCT plus radiation, 1,046 (12.4%) underwent total mastectomy plus radiation, and 695 (8.3%) were treated with partial mastectomy alone.

The 10-year survival rate was 74% in the BCT plus radiation group compared with 56% to 58% in the other groups.

“The patients’ clinical characteristics were the same, but BCT patients were more likely to have received chemotherapy, which may explain their improved overall survival. My takeaway from this is that BCT is at least equivalent to total mastectomy in male patients, and that radiation therapy remains an important component, just as it does in women,” Dr. Pass said.

Prognostic impact of breast conserving therapy versus mastectomy of BRCA1/2 mutation carriers compared with noncarriers in a consecutive series of young breast cancer patients Ann Surg 2019;270(2):364-372 https://pubmed.ncbi.nlm.nih.gov/29727326/

To assess whether BCT is appropriate in BRCA1/2 mutation carriers, researchers evaluated survival outcomes in 5,820 non-carriers, 191 BRCA1 carriers and 70 BRCA2 carriers. About half of the patients in all three groups underwent

‘Breast-conserving therapy is at least equivalent to total mastectomy in male patients, and ... radiation therapy remains an important component, just as it does in women.’

—Helen Pass, MD

BCT. After adjusting for pathologic factors, there was no difference in overall survival and local recurrence at 10 years between non-carriers and BRCA1 carriers; the numbers were too small to draw conclusions for BRCA2 carriers.

“This shows us that BCT is at least equivalent to total mastectomy in BRCA1 patients. We have a knee-jerk reaction that patients with a BRCA mutation will want a bilateral mastectomy, but perhaps this is a prejudiced bias we shouldn’t be having. We need to be able to offer these patients BCT and reassure them that their outcome from the existing tumor will be exactly the same,” Dr. Pass said.

Local recurrence of breast cancer: salvage lumpectomy as an option for local treatment Breast J 2019;25(4):619-624 https://pubmed.ncbi.nlm.nih.gov/31087430/

To identify the role of salvage lumpectomy (SL) in patients with a local recurrence, researchers conducted a retrospective review of 121 patients with solitary, unifocal, in-breast tumor recurrence (IBTR). Of the patients, 47 underwent SL and 74 were treated with salvage mastectomy. Eight SL patients (17%) and 10 salvage mastectomy patients (13%) developed a third local recurrence, but overall survival at 10 years was about 97% in both groups.

“This suggests that SL is an acceptable option for select patients with unifocal IBTR after BCT,” Dr. Pass said.

“Many women are more than willing to have multiple procedures on their breast to save their breast as long as it will not affect their survival. At a median followup of 14 years, 85% of the SL patients were mastectomy free.”

Effectiveness of breast conserving surgery and 3-dimensional conformal partial breast irradiation for recurrence of breast cancer in the ipsilateral breast JAMA Oncol 2020;6(1):75-82 https://pubmed.ncbi.nlm.nih.gov/31750868/

To explore whether partial breast irradiation is an acceptable alternative to mastectomy in women with a recurrence after prior BCT with whole breast irradiation, researchers prospectively enrolled 65 patients, 58 of whom were evaluable. At a median follow-up of five years, four patients had a third ipsilateral breast cancer event (all DCIS). Overall survival was 98% and distant metastasis‒ free survival was 95%.

“Historically, we’ve treated IBTR with

IN THE NEWS

SEPTEMBER 2020 / GENERAL SURGERY NEWS

mastectomy. These two studies show that in selected patients, repeat BCT with or without radiation may be feasible. Follow-up was relatively short in this trial, but more than 14 years in the other one.

If we have to wait for 20-year maturation from every trial to change what we’re doing, we’ll never advance. I think it’s time to offer select patients with IBTR after BCT the option of a second attempt at BCT,” Dr. Pass said.

Oncotype DX recurrence score as a predictor of response to neoadjuvant chemotherapy

of toxicity data may be limited since many of these women were much younger than those in other studies,” Dr. Pass said.

Seven-year follow-up analysis of adjuvant paclitaxel and trastuzumab trial for nodenegative, human epidermal growth factor receptor 2-positive breast cancer (AKA, the APT trial) J Clin Oncol 2019:37(22):1868-1875 https://pubmed.ncbi.nlm.nih.gov/30939096/

In this secondary analysis, researchers reported longer follow-up data on

research that had demonstrated a threeyear DFS rate of 98.7% among women with small HER2-positive cancers who took paclitaxel plus trastuzumab weekly for 12 weeks followed by trastuzumab alone for nine months. At seven years, overall survival was 95% and cancer-specific survival were 95% and 99%, respectively.

“This is great, but the data does not support the use of trastuzumab for all patients with small tumors. The NCCN [National Comprehensive Cancer Network] guidelines say to consider trastuzumab in patients with node-negative

tumors less than 5 mm; they recommend it in node-positive patients; and in patients with tumors 6 mm to 1 cm, they suggest endocrine therapy or chemotherapy with trastuzumab,” Dr. Pass said.

“This was not a randomized trial, so we are lacking the highest class of data. But I think more and more, medical oncologists are looking at deescalating the chemotherapy, and they believe trastuzumab is a very important actor in this group of patients.”

■ Disclosures: Dr. Pass is on the speaker’s bureau for Genentech and Genomic Health.

Ann Surg Oncol 2019;26(2):366-371 https://pubmed.ncbi.nlm.nih.gov/30542840/

To evaluate the role of the Oncotype DX (Genomic Health) assay in NAC, researchers used the National Cancer Database to identify 989 patients with Oncotype DX recurrence scores who underwent NAC. Of these patients, 42 achieved a pCR, and there was a significant association between a high recurrence score and pCR. The authors suggested that Oncotype DX recurrence score be used in clinical decision making.

“During the COVID-19 crisis, as we’re trying to classify our patients, we are also using Oncotype DX to figure out whom to offer NAC and whom to offer neoadjuvant endocrine therapy. Again, the sequencing of chemotherapy continues to evolve, and this data may be helpful,” Dr. Pass said. “But it’s also important to recognize that using Oncotype DX on core samples to guide treatment decisions is not consistent with current guidelines.”

Randomized placebo-controlled trial of low-dose tamoxifen to prevent local and contralateral recurrence in breast intraepithelial neoplasia J Clin Oncol 2019;37(19):1629-1637

To test their hypothesis that 5 mg of tamoxifen per day for three years would be as effective as the same dose taken daily for five years but with lower toxicity, researchers randomized 500 breast cancer patients aged 75 years or younger (mean age, 54 years) to the low dose/ duration drug or placebo, with a primary end point of DCIS or invasive breast cancer. At a median follow-up of five years, tamoxifen recipients had 14 new invasive cancers or DCIS and the placebo group had 28. There were no differences in serious adverse events and quality-of-life score between the groups, although the tamoxifen group reported more frequent hot flashes.

“We know chemoprevention is effective, and anything that improves the toxicity profile may increase patient acceptance. We have also learned to wait for longer follow-up. Also, extrapolation

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20

IN THE NEWS

GENERAL SURGERY NEWS / SEPTEMBER 2020

Calculator Helps Predict Ductal Hyperplasia-to-Cancer Progression

By MONICA J. SMITH

A

simple risk calculator may help predict low-risk patients with atypical ductal hyerplasia for whom observation is a safe alternative to surgery, according to new research.

“Some studies have begun to challenge the current paradigm in an attempt to avoid unnecessary surgery in low-risk patients; however, it’s quite difficult to predict which patients will have benign disease and which will upstage to cancer,” Daniel Lustig, MD, a surgical resident at the University of British Columbia, in Vancouver, said.

“We set out to identify risk factors associated with ADH [atypical ductal hyperplasia] upstaging to cancer on core needle biopsy [CNB], and then to develop a risk calculator capable of stratifying women into low- and high-risk categories.”

Using a prospectively designed database, Dr. Lustig and his colleagues looked at the association between 10 clinical, radiological and pathologic variables and the likelihood of ADH upstaging to cancer in 290 women between 2013 and 2017.

After univariate regression analysis,

the researchers identified five variables associated with progression to cancer: • suspicion for ductal carcinoma in situ (DCIS); • more than one high-risk lesion; • size on mammogram; • size on ultrasound; and • whether all calcifications had been removed after CNB. “The variables most significantly associated with upstaging to cancer were suspicious for DCIS and one or more high-risk lesion, with odds ratios of 9.5 and 3.6, respectively,” Dr. Lustig said.

Using those five variables, Dr. Lustig and his colleagues developed a calculator, assigning a score of 1 for every metric present, with a scoring system ranging 0 to 5. Patients with a score of 0 are low risk, with only 2% likely to develop cancer; those with a score of 1 or higher are high risk, with 17% to 100% likely to upstage depending on the number of metrics present.

“As the risk score increases, so does the risk of finding a malignancy after the final surgical excision,” Dr. Lustig said.

To prospectively validate the calculator, they examined a cohort of patients who had undergone surgery for ADH.

They found that the calculator’s predictions aligned closely with the actual patients’ progression rates.

“In our study, 50 women (17%) may have been able to avoid unnecessary surgery,” Dr. Lustig said.

In the study, 17% of patients may have been able to avoid unnecessary surgery.

“The current recommendation for BIRADS [Breast Imaging-Reporting and Data System] category 3 lesions, which have a 2% or less risk of being cancer, is not a tissue diagnosis by surgery but short-term follow-up. We propose offering observation and six months to patients with a score of 0, and recommend operations for those with a risk score of 1 or more.”

Dr. Lustig and his team are working on refining the calculator by applying different score weightings to the various metrics. He presented the research at the American Society of Breast Surgeons’ Virtual Education Series, and received recognition for Best Scientific Presentations.

Carla S. Fisher, MD, an assistant professor of surgery at Perelman School of Medicine of the University of Pennsylvania, in Philadelphia, called the calculator “a brilliant tool” for a diagnosis that breast surgeons see commonly.

“While we don’t want to miss a cancer diagnosis, we know we are doing a lot of unnecessary surgery. Unfortunately, we’ve really struggled to find a bestprediction model. One of the nice things about this study is that they retrospectively identified risk factors and then prospectively validated their prediction tool, which makes it more robust.”

Dr. Fisher, who is the program director of the breast fellowship at the Hospital of the University of Pennsylvania, in Philadelphia, looks forward to further refinement of the calculator, but said it would be useful as is.

“I think most breast surgeons would agree that these variables are things we already use to discuss with our patients; for instance, in patients with ADH, I always review whether all calcifications have been removed after CNB. But this is a simple tool, easy to use, and you can share it with patients to support a decision for or against surgery.”

■

IN THE NEWS

SEPTEMBER 2020 / GENERAL SURGERY NEWS

21

Most Lumpectomy Patients Can Do Without Opioids Study Shows Few Require Narcotics to Control Pain

By MONICA J. SMITH

S

urgeons routinely prescribe opioids to breast cancer patients undergoing lumpectomy, but most patients, including those whose surgery also involves sentinel lymph node biopsy, can control pain with nonnarcotic medication, according to new research.

In 2018, Memorial Sloan Kettering Cancer Center (MSKCC) eliminated routine opioid prescriptions for patients undergoing lumpectomy with no axillary procedure, replacing the narcotic medications with over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen.

“As only 1% of our patients required an opioid for pain control with this regimen, we hypothesized that patients having lumpectomy with sentinel lymph node [SLN] biopsy could also be routinely discharged without opioids with a low failure rate,” said Tracy-Ann Moo, MD, a breast surgical oncologist at MSKCC in New York City.

To test their hypothesis, Dr. Moo and her colleagues studied 663 patients over a six-month period. In the first three months, most patients (92%) were discharged with prescriptions for opioid medications. In the following threemonth period, patients were sent home with NSAIDs and instructions to use acetaminophen as needed; only 14% of patients were prescribed opioid medications, mostly due to a contraindication to NSAIDs. In a post-discharge survey, patients reported daily pain on a scale of 0 to 10 for five days after surgery, and on day 5 reported the number of opioids or nonnarcotic medications they had taken to that point.

During the opioid prescribing period, 61% of patients reported taking no pills; among those who used the medications, the median number of pills taken by postoperative day 5 was four. During the nonnarcotic medication period, only five patients sent home with NSAIDs required opioids, for a failure rate of 2%.

“Comparing the maximum reported pain scores of postoperative days 1 to 5 in both study periods, we found no difference between patients treated during the first three months and those treated in the second three months,” Dr. Moo said. “Furthermore, the pain scores were comparable between the two time periods, with most patients reporting 0 or mild pain.”

The shift to prescribing narcotic medications as needed rather than routinely

after lumpectomy with SLN biopsy resulted in a plunge of 78% in opioid prescriptions between the two time periods.

“At MSKCC, where surgeons treat approximately 2,500 breast cancer patients annually with these procedures, this translates into 19,500 fewer opioid pills being dispensed annually, a dramatic reduction in the number of pills that could potentially be misused,” Dr. Moo said. She presented her research at the American Society of Breast Surgeons’

Virtual Education Series, held in lieu of the society’s 2020 annual meeting.

Theresa Schwartz, MD, a professor of surgery at Saint Louis University School of Medicine, in St. Louis, stopped prescribing narcotic medications for all patients not undergoing reconstruction after reading the book “Dopesick: Dealers, Doctors, and the Drug Company That Addicted America,” by Beth Macy (Little, Brown and Co.; 2018), which describes the marketing tactics of the

manufacturers of oxycodone and the vulnerability of everyday people to narcotic medications.

“It really doesn’t take much. You don’t have to be on narcotics for an extended period to become addicted. For some people, withdrawal symptoms are felt after only a few days of use,” she said.

In the 18 months since she stopped routinely prescribing narcotics, Dr. Schwartz hasn’t had one patient call continued on page 26

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22

OPINION

GENERAL SURGERY NEWS / SEPTEMBER 2020

Is There a Magic Bullet for COVID-19?

How the Science of Netflix’s Algorithms Could Be Applied to Health Care

By BRUCE RAMSHAW, MD

WĂƟĞŶƚ ĂŶĚ ŶǀŝƌŽŶŵĞŶƚĂů &ĂĐƚŽƌƐ

/ŶƚƌŽĚƵĐƟŽŶ ŽĨ sŝƌƵƐ

KƵƚĐŽŵĞƐ

/ŶƚĞƌǀĞŶƟŽŶͬdƌĞĂƚŵĞŶƚ

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DŝŶŝŵĂů Žƌ ŶŽ ƐLJŵƉƚŽŵƐ

T

hirty-one years ago, I did my first night of call as a new surgery intern in Atlanta. It was intimidating. We were often evaluated in medical school by how well we could identify the one right answer on a multiple-choice test. I remember I would try to have a single solution for whatever the nurse called me for: one antihypertensive for a patient with high blood pressure, one sliding scale of insulin for a patient with a high glucose level, and so on.

I’ll never forget the very first call from a nurse, probably 10 minutes into my night. The nurse said she had a post-op patient with constipation and asked if I could give her an order for a suppository. I froze. (I hadn’t yet learned how valuable nurses are in helping residents on call, especially in their first year.) I said to wait just a minute and I would call back. I went to the senior resident call room where the chief resident on call and another senior resident were talking. I interrupted them to ask if it was OK to order a suppository for a patient with constipation. They looked at each other, and one said, “Uh, yeah.” I’m sure they had a good laugh after I left and thought, “That intern won’t last long.”

Having one primary treatment for any medical disease or symptom makes sense on the surface, until you realize that all disease—and everything in our biological world—is complex. That means there will never be one right treatment or a “magic bullet” for any disease. As much as we would like reductionist science to be true— that we can identify a single cause leading to an effect; that things are black and white; that a drug or device is good or bad; that there is one right answer—it’s not how our real, biological world works.

More than 100 years ago, Dr. Paul Ehrlich, a German physician and scientist, promoted the concept of a magic bullet cure for any infectious disease. He won a Nobel Prize in 1908, which led to the growth of antibiotics. The drug that Dr. Ehrlich and his team eventually discovered was called Salvarsan, a treatment for syphilis. It was tolerated better than the previous mercury-based treatment, but it didn’t work for everyone. It also had some severe side effects, including fever, rash, liver damage, limb loss and even death. Salvarsan was clearly an improvement in the treatment of syphilis, but it was no magic bullet.

In a recent article published by FDA researchers in the journal Frontiers in Immunology, they presented lessons learned about COVID-19. In their conclusion, they noted, “We are learning day after day, that patients may be affected by SARS-CoV-2 differently and that many factors influence the outcomes of the disease.” This is true for any disease, whether it’s obesity, cancer, addiction or depression; all are complex and the result of many factors, and will affect subpopulations differently. In the same way, any potential treatment for COVID-19, such as hydroxychloroquine, will have different outcomes for different subpopulations.

There may be benefit for some, and it may contribute to unintended harm for others. If there is no harm or benefit, then giving the drug would be wasteful.

The following illustrations are intended to help demonstrate the principles of systems science applied to the COVID-19 virus (Figure 1) and for one proposed treatment, hydroxychloroquine (Figure 2).

WĂƟĞŶƚ ĂŶĚ dƌĞĂƚŵĞŶƚ &ĂĐƚŽƌƐ

ĞŶĞĮƚ

DŽĚĞƌĂƚĞ ƐLJŵƉƚŽŵƐ

Ks/ Ͳϭϵ

hŶŝŶƚĞŶĚĞĚ ,Ăƌŵ

^ĞǀĞƌĞ ŝůůŶĞƐƐ ĂŶĚ ƉŽƚĞŶƟĂů ĚĞĂƚŚ

/ĚĞŶƟĨLJ ƉĂƟĞŶƚ ƐƵďƉŽƉƵůĂƟŽŶƐ ĨŽƌ ĂŶLJ ƚƌĞĂƚŵĞŶƚ ĨŽƌ Ks/ Ͳϭϵ

/ĚĞŶƟĨLJ WĂƟĞŶƚ ^ƵďƉŽƉƵůĂƟŽŶƐ ĨŽƌ ŶLJ ŝƐĞĂƐĞ WĂƟĞŶƚ ĂŶĚ ŶǀŝƌŽŶŵĞŶƚĂů &ĂĐƚŽƌƐ

/ŶƚƌŽĚƵĐƟŽŶ ŽĨ sŝƌƵƐ

KƵƚĐŽŵĞƐ

WĂƟĞŶƚ ĂŶĚ dƌĞĂƚŵĞŶƚ &ĂĐƚŽƌƐ

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DŝŶŝŵĂů Žƌ ŶŽ ƐLJŵƉƚŽŵƐ

Hydroxychloroquine

Factor Highly Correlated with Minimal Symptoms /ŶƚƌŽĚƵĐƟŽŶ ŽĨ sŝƌƵƐ

&ĂĐƚŽƌƐ ,ŝŐŚůLJ ŽƌƌĞůĂƚĞĚ ǁŝƚŚ ĞŶĞĮƚ

KƵƚĐŽŵĞƐ

Factor Highly Correlated with Moderate Symptoms /ŶƚƌŽĚƵĐƟŽŶ ŽĨ sŝƌƵƐ

WĂƟĞŶƚ ĂŶĚ dƌĞĂƚŵĞŶƚ &ĂĐƚŽƌƐ

DŽĚĞƌĂƚĞ ƐLJŵƉƚŽŵƐ

COVID-19

WĂƟĞŶƚ ĂŶĚ ŶǀŝƌŽŶŵĞŶƚĂů &ĂĐƚŽƌƐ

KƵƚĐŽŵĞƐ

ĞŶĞĮƚ

COVID-19

WĂƟĞŶƚ ĂŶĚ ŶǀŝƌŽŶŵĞŶƚĂů &ĂĐƚŽƌƐ

tĂƐƚĞ

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KƵƚĐŽŵĞƐ

tĂƐƚĞ

Hydroxychloroquine

Factors Highly Correlated with Waste

KƵƚĐŽŵĞƐ

Ks/ Ͳϭϵ

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Hydroxychloroquine ^ĞǀĞƌĞ ŝůůŶĞƐƐ ĂŶĚ ƉŽƚĞŶƟĂů ĚĞĂƚŚ

Factor Highly Correlated with ^ĞǀĞƌĞ /ůůŶĞƐƐ ĂŶĚ WŽƚĞŶƟĂů ĞĂƚŚ

Figure 1. Principles of systems science applied to the COVID-19 virus.

These figures demonstrate the same principles of systems science that Netflix uses to identify subpopulations of viewers—what they call “taste groups.” Using data from viewers, data from each show, and data from each local environment (language and cultural variables), the algorithms can provide show recommendations for each subpopulation to drive customer retention and satisfaction.

The same scientific principles could be applied in health care by first defining the whole patient process (COVID-19 infection in this example). Then working with clinical teams in each local environment, patient and treatment data that matter the most could be collected, and outcomes could be measured and collected. As more and more data are collected, algorithms could be generated, and their accuracy would improve over time.

I wish I had been able to use systems science tools when I was in training. With the appropriate systems

hŶŝŶƚĞŶĚĞĚ ,Ăƌŵ

Factors Highly Correlated with Harm

Figure 2. Systems science applied to hydroxychloroquine as a treatement for COVID-19.

and data science infrastructure in place, my response to my first call from a nurse could have been very different.

Based on several factors specific to the patient with constipation, an algorithm may have suggested that magnesium citrate by mouth would be more likely to have the best value for this patient rather than a suppository.

Instead of asking the chief resident if it was OK to order it, I would ask the nurse and the patient to make sure we all agreed—a data-informed, shared decision process.

But without an appropriate data infrastructure in place in health care, we will continue to wait for that magic ■ bullet. How long do we have to keep waiting?

—Dr. Ramshaw is a general surgeon and data scientist in Knoxville, Tenn., and a managing partner at CQ Insights. He is an editorial advisory board member of General Surgery News. You can read more from him on his blog: www.bruceramshaw.com/blog.

OPINION

SEPTEMBER 2020 / GENERAL SURGERY NEWS

Are We the COVID-19 Patients? continued from page 1

and perfects them, like a diamond that is cut and then polished.

As I enter my final year of training, I pause. I trepidate. And I worry. This culminating year of promised richness of learning is now dauntingly desolate and uncertain. While this is an exceptional time in modern medicine that has universally forced the world to reinvent itself, the reality is that we will inevitably have to make excuses for lost experience.

As the number of COVID-19 patients increases, the number of elective operations predictably decreases, and the complexity and difficulty of acute care operations increases. The first change leads to a gap that is palpable at all levels of training. The elective inguinal hernia repair, a fundamental milestone in every surgery internâ&#x20AC;&#x2122;s experience, is canceled. The elective cholecystectomy that junior residents learn to perform safely and smoothly is postponed. The complex paraesophageal hernia that the chief prepared for is now put off.

These may seem like minor lapses in experience, but the truth is that every moment of every day shapes us into the surgeons we become. Surgical residency is fast, intense, and pushes one to unimaginable limits. One step behind in the training of a surgical resident becomes one full block behind. A few missed elective cases may seem insignificant to an attending, but can be truly disheartening to a trainee.

At the other extreme, the pandemic has led patients to delay care for acute problems that they would otherwise have addressed right away. A minor skin break progresses to a monstruous necrotizing soft tissue infection. Abdominal pain is now endured for days at home by patients who are fearful of exposing themselves to the dangers of a busy ER. What would typically be a bread-andbutter junior-level acute appendicitis is now a senior-level open ileocecectomy. The routine cholecystitis becomes a gangrenous subtotal open cholecystectomy. I loved taking my juniors through cases and cherished these moments as an invaluable bidirectional learning experience. Lately, I found myself taking over the case with the attending, as it was too difficult for a junior to navigate. And while I missed the chief-level complex elective cases, I continued to expand my operative numbers of appendectomies and cholecystectomies into the hundreds.

No case is too small. Yet I cannot help wonder if the training my generation of surgery residents is undergoing will be forever chipped by the stark reality that has engulfed the world. Will I have to make excuses later in life that my proficiency in certain areas has suffered? Will my

Will my future patients know that I trained during the COVID-19 era, and that, undoubtedly, there will be gaps in my skill level? future patients know that I trained during the COVID-19 era, and that, undoubtedly, there will be gaps in my skill level? Do we all remain perfectly cut yet unpolished diamonds by the time we graduate?

Books and videos and simulation lab will never replace intraoperative experience. The learning that occurs in a busy

workroom where different years of trainees mix together and learn from each other is encumbered by social distancing rules.

Surely, the knowledge I gained from caring for COVID-19 patients, the hypersensitivity that I now foster of evaluating for medical and surgical complications secondary to the virus, and the arduous

task of operating for an entire day in an N95 will not make me a polished surgeon.

I feel more confident than ever in my ability to manage complex acute care surgical problems, but ultimately uncertain about the wholeness of my generationâ&#x20AC;&#x2122;s training.

Are we the COVID-19 surgeons? And if â&#x2013; so, how do we catch up? â&#x20AC;&#x201D;Dr. Baiu is a chief resident in general surgery at Stanford University, in California.

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3. Based on internal report #US170824, Global value dossier for LigaSureâ&#x201E;˘ technology. Oct. 26, 2017. 4. Based on internal test report #RE00065374 Rev A, LF18XX product claims report for reprocessed jaws. Sept. 22 and Sept. 29, 2016. 5. Based on internal test report #RE00065124, Lig-40 LF4418 product claims report for reprocessed jaws: benchtop testing conducted with reprocessed device jaws using porcine tissue, porcine blood, and average (lb) tissue sticking force. Oct. 4â&#x20AC;&#x201C;7, 2016. 6. Based on internal report #RE00045785, LF19XX Waiver of Sticking Testing Post-reprocessing. Jan. 19, 2017.

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OPINION

GENERAL SURGERY NEWS / SEPTEMBER 2020

There Are No Superheroes

By SAMUEL P. CARMICHAEL II

I

am a trauma surgeon, and this past year, before the COVID-19 pandemic, I lost my voice. Fortunately, it returned a couple of weeks later, but the meantime was filled with broken messages. Speaking over the telephone was especially challenging, and conversations on rounds were largely conducted via resident proxy.

I specifically recall entering an elderly patient’s room the morning after she was admitted with rib fractures from a fall. I introduced myself in raspy tones, and she quickly commented sympathetically, “Oh, no; doctors can’t get sick.”

Most of the time, we would agree, although not as a physiologic impossibility. The medical community is a profession comprised of many who see

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

themselves as beyond simply durable or resilient. Training itself is a marathon that, not uncommonly, dispels the faint

Management News The Independent Source of News for Operating Room Managers, Supply Chain Professionals & C Suite

of heart. Although duty hours are regulated, often real-life circumstances disrespect time, and one day bleeds into the next. We battle the villains of death and disease, often to victory, conceding loss more than we would prefer. Our powers are modern medical and surgical therapies, vanquishing all but the foulest of adversaries. Personal illness is no more than an inconvenience that many of us throw across our shoulders to do the right thing.

The funny thing about superheroes is that they appear ordinary. They walk among crowds, even holding down normal jobs, without anyone being the wiser.

They are entirely unremarkable, until called upon to provide a miraculous service. In such times, their capabilities unbind them from the laws of physics and nature. Feet lift off the ground; energy is dispatched through the hands or eyes, and weapons are wielded with superhuman perfection. At once, or without prolonged difficulty, the fight is won and evil is defeated. To the spectator, victory was a foregone conclusion.

The elderly woman’s comments on rounds reiterated to me that the hospital is a place of vulnerability. No one plans to be a sick patient. It only serves to remind us of our own frailty and limitation. Although we may not consider ourselves finite in the midst of the day-to-day, eventually life is interrupted, often despite our best-laid plans. In such circumstances, specters of doubt, fear and desperation come over us as we ponder thoughtfully over our own humanity.

Therefore, in such positions of compromise, it is no great stretch to wish for rescue or a rescuer. How wholly disconcerting it must be to consider that person subject to the same weaknesses that suddenly intruded upon our lives.

There is something in each of us that wishes superheroes were real. Someone, otherwise ordinary in appearance, who could don a cape and protect us from evil would be immeasurably comforting. In reality, no number of force fields or white coats can stand invincibly in the way of suffering. The world is cold at times, and doctors really can get sick. During such times when the quest for healing is compromised and the fight appears to be jeopardy, it is our capacity to suffer alongside one another that makes us truly super. While it would be an invaluable luxury to call upon someone with the power to fly us away from our circumstances, a true hero’s feet may ■ never have to leave the ground.

—Dr. Carmichael is a trauma surgeon in Winston-Salem, N.C.

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25

26

GENERAL SURGERY NEWS / SEPTEMBER 2020

response

Where Have All the Medical Journals Gone?

Only Read the Yellow

then why should I bother to read the results section?

Soon after, I would just read the table of contents and

By LINDA WONG, MD pick out the interesting stuff. Articles that had SpragueDawley rats or knock-out mice were ignored, because, received my first medical jour- well, that was not going to help me practice medicine nal shortly before starting med- tomorrow if the latest medicine or operation had not ical school. It was a freebie even been tried on humans yet. journal that I acquired at a sumAnother 10 years passed and more of this informamer research program when one tion began showing up online. Journal publishers had of the physicians was clean- started to realize that printing all this stuff on nice ing his desk. Giving it to some glossy paper with thick covers and mailing them all eager beaver summer student was over the country was expensive and not environmentally the next best option before the trash can. I carried it conscious. Instead, journals started online subscriptions. around proudly for a few weeks and felt smarter just They charged a fee, gave me a password and allowed holding it. I had to look up every third word in a medi- access to all the articles, any time of the day or night. cal dictionary, but that did not deter me.

I could even get them on my phone.

In medical school, I managed to get my hands on After a massive office cleanup, I realized there were a few medical journals during my clinical rotations. not many printed journals these days. It was pleasing to Again, these were freebies that were about to be dis- my guests who commented on this newly decluttered carded. I could understand them better with two years office and their newfound ability to actually sit on the of medical school under my belt. At least I could pro- chairs. But without glossy journal piles sitting on the nounce the words and only needed the medical diction- floor, there was no way to know if I was keeping up with ary for every 15th word. I watched the residents tote the medical literature. It used to be that I was 25 incharound medical journals and I envied that they could es behind in medical journal reading and the stack was take in all of the information. They referred to them as a constant reminder of the need to read, catch up, stay “the blue journal” or “the yellow journal.” current, stay smart. I think I am smart, but the dwindled In surgical residency, I figured out which colored stacks of reading say otherwise. journals were more important. I also experienced jourI now have mostly online journals. My paper journal club. I thought this would be some fun club event nal floor stack never exceeds three inches. I can barewhere we all sat around reading, but it turned out we ly remember the online passwords to get access to the had to read a lot before even going to the club. We online articles. No password, no reading. My daily inbox did not carry around the journals but just had reprints now contains a flurry of emails from medical journals. stuffed in our lab coat pockets because the actual jour- Some are legitimate journals, but others are obscure nal was just too big. We sometimes went journals, open-access It used to be that I was 25 journals, internationthrough packets of “Selected Readings in Surgery,” which came to be known affecand journals inches behind in medical journal althatjournals, tionately as “Neglected Readings.” seem a bit sketchy. reading and the stack was a Some of them land in By the time I became an attending, I was no longer fascinated with the medispam folder along constant reminder of the need my cal journal. While I was happy to receive with the ads for nutrito read, catch up, stay current, tional supplements, Tarmail, these journals were stacked up in my office as a constant reminder of the need to gummy vitamins, stay smart. I think I am smart, get, keep up with the current literature. UnforCBD oil and home but the dwindled stacks of warranties. However, I tunately, there was no wayy to read all of ime to actualthese journals and have time not feel less smart reading say otherwise. ddo n the shelves oor guilty hitting the ly practice surgery. When filled up, I started stacking journals on delete button. It’s easier d the floor and chairs. I read ad about tto delete than it was to erved aactually toss the glossies half of them, and the rest served iin the trash. as a door stop or perhaps even furniture.

Do we actually read racth About 10 years into practhe online versions as m tice, I realized if I read the much as the printed sion abstract and the discussion ones? It’s tough to read of any paper, I could get on the phone. There he the gist of the article. The are two options: 1) ebl methods section was someblow up the font so you d ca thing I skimmed over, and can read it one sentence s, at a time, or 2) keep the if I looked at the tables,

I

Opioids continued from page 21

with uncontrolled pain. “That’s anecdotal information, and it helps me make appropriate decisions for my patients

specifically, but this paper presents real data that demonstrates patients have adequate pain control without the use of narcotic medication.”

But the culture that evolved around narcotics is complicated, and may be

font small so you can scan the whole page, but then you need a microscope to even see the section headings. While the computer monitor is better visually, it is tough to concentrate on e-journal reading when we are so distracted by other things—emails, texts, news, EMR, advertisements, internet shopping, and random thoughts that need to be Googled. When I get irritated, I press “select all” and “delete.” That is how I get caught up now—virtual trash.

There are simply too many articles and journals. Gone are the days when we can all gather and discuss that one seminal paper, that randomized prospective clinical trial that changed everything. Oh, those still exist, but they are buried in paper after paper on the same subject, and if there are 10 papers on the topic, then you will find five meta-analyses of various groups of these 10 papers.

It would take a meta-analysis of all the meta-analyses to try to answer the question and still there would be limitations on that paper. There are now apps that try to keep us up-to-date, but these apps look at what they think is the important latest information. Is it what I think is important? We are drowning in papers, articles and electronic journals, but are we any smarter? And how will we sift through all of these data and find the most important papers?

With all of the mountains of words and supposed facts, findings and conclusions bombarding us each day, I think there is a lot of flat-out wrong and possibly dangerous information floating around. Hydroxychloroquine? You get the point.

We need a better system, a Dewey Decimal relevance system. Or we can take lessons from the old days and color-code each journal, each article. Perhaps journals with the highest impact factor can be labeled yellow, and those that come from obscure places with low impact factor can be gray or black, and the in-between journals can have different ratings and colors. This way, I can just read the yellow articles and take all those emails from black and gray journals and hit delete. But give me the yellow journal. Would it be prestigious if I sat on the editorial board of the yellow journal?

In the words of Dr. Thomas Brittingham, the brilliant teacher-physician at Vanderbilt University Medical School in the 1970s: “I don’t mind if a day goes by in which I do not learn something new. But I hate each day when I learn something that is wrong.” Dr. Brittingham was a genius. He did not need any color coding. But, for the rest of us, we need a yellow medical ■ journal world. Everything else—delete.

—Dr. Wong is a professor of surgery at the University of Hawaii Cancer Center, in Honolulu.

Column editor: Gary H. Hoffman, MD, is the surgical director at Los Angeles Colon and Rectal Surgical Associates (www.lacolon.com), an attending surgeon at Cedars-Sinai Medical Center, and an instructor in the Cedars-Sinai colon and rectal surgical fellowship, in Los Angeles.

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