General Surgery News - April 2021 by McMahon Group

The EEA™ Circular Stapler With Tri-Staple™ Technology......Page 8

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

April 2021 • Volume 48 • Number 4

Court Ruling Alters Informed Consent Process

Overnight Telemedicine Services Reduce Mortality In ICU Patients

Physicians and Researchers React to Pennsylvania Ruling, Hoping to Avoid Litigation

By CHRISTINA FRANGOU

atients in the ICU who received telemedicine services overnight were less likely to die, and were more likely to be discharged quicker than patients receiving traditional ICU care with no on-site intensivist overnight, according to a study presented at the 2021 Critical Care Congress Virtual Event. The retrospective study ended just before the COVID19 pandemic began, but the results underscore the value of ICU telemedicine at a time when critical care specialists are in short supply, according to the investigators. “In an ideal world, patients would have an intensivist at the bedside 24/7, but the reality is that even if we had all of the money in the world, we don’t have enough trained professionals to do the job,” said Chiedozie I. Udeh, MD, a critical care anesthesiologist at the Cleveland Clinic

By CHRISTINA FRANGOU

four-year-old ruling by the Pennsylvania Supreme Court is making doctors and researchers across the country change the way they obtain patients’ informed consent, according to a panel of experts who spoke at the 2020 virtual Clinical Congress of the American College of Surgeons. Many physicians, researchers and administrators are concerned that the landmark decision, Shinal v. Toms, leaves them vulnerable to legal Continued on page 22

Continued on page 13

The Post-Bariatric Patient With Complications

Short or Long Course Of Antibiotics for Intraabdominal Infections?

Tips on Diagnosis and Management For the Nonbariatric Surgeon

Evidence Leans Toward Shorter Duration, But Uncertainty Remains

By MONICA J. SMITH

By VICTORIA STERN

any general surgeons have only six weeks or so of training in bariatric surgery during residency, but they are likely to encounter post-bariatric surgery patients who will need their help. At the American College of Surgeons 2020 virtual Clinical Congress, surgeons discussed their approaches for treating these patients, who should see them, and when surgical intervention is urgent.

ow long should patients with intraabdominal infections receive antibiotics? Guidelines issued by the Surgical Infection Society and the Infectious Diseases Society of America in 2010 recommend limiting antimicrobial therapy from four to seven days in patients with adequate source control. However, in clinical practice, treatment for these patients typically lasts much longer—10 to 14 days, according to several reports (Surg Infect

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PRODUCT ANNOUNCEMENT

IN THE NEWS

3 Dexmedetomidine, Propofol Have Similar Outcomes in Ventilated Septic Patients J OURNAL WATCH

4 Anal Fistula; Cerebrovascular Injury; Opioids T H E GREAT DEBATES

14 Mandating Intraopertive Cholangiography

Arthrex Launches SynergyID™ Multispecialty Surgical Video System PAGE 16

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OPINION

Traumatic Brain Injury By HENRY BUCHWALD, MD, PhD

pproximately half of all Americans have sustained at least one traumaticc brain injury (TBI) due to major accidents, assault, military trauma and sports injuries. It is estimated that each year there are 2.8 million TBIs in the United States and 69 million worldwide, at a financial cost of $4 billion in the United States and $400 billion globally. Recent national focus on TBIs has been the result of the press coverage given to the longterm significance of frequently sustained concussions in the game of football. Continued on page 24

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IN THE NEWS

APRIL 2021 / GENERAL SURGERY NEWS

Dexmedetomidine, Propofol Have Similar Outcomes in Ventilated Septic Patients By CHRISTINA FRANGOU

echanically ventilated adults with sepsis who received light sedation had similar outcomes whether they received dexmedetomidine or propofol, according to results from a multicenter, randomized trial. The findings from the MENDS2 (Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure) trial were presented at the 2021 virtual Clinical Congress of the Society of Critical Care Medicine and published simultaneously in The New England Journal of Medicine (2021, Feb 2; [Epub ahead of print]). Dexmedetomidine, an alpha-2 receptor agonist, did not improve days alive without acute brain dysfunction, ventilator-free days, deaths at 90 days or global cognition at six months in patients with sepsis, compared with propofol. Previous trials indicated that dexmedetomidine may be superior to benzodiazepines in improving outcomes such as delirium, coma and time receiving mechanical ventilation. The findings from MENDS2 reinforce current guidelines recommending the use of dexmedetomidine or propofol for light sedation when continuous sedation is needed. “The choice between dexmedetomidine and propofol alone does not appear to substantially affect patient

Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC

outcomes in the complex milieu of critical illness with sepsis,” lead investigator Christopher Hughes, MD, a professor of anesthesiology at Vanderbilt University Medical Center, in Nashville, Tenn., and his colleagues wrote in their journal publication. Safety end points were similar in the two groups. At 13 centers across the United States, researchers randomly assigned mechanically ventilated adults with sepsis to receive dexmedetomidine (0.2-1.5 mcg/kg per hour) or propofol (5-50 mcg/kg per minute), with doses adjusted by bedside nurses to achieve the target sedation goals set by clinicians About 25% of patients had clinically important according to the Richmond Agitation Sedation Scale (RASS). The IV fluid bags and cognitive dysfunction after sepsis, with no tubing were hidden under opaque coverdifference between dexmedetomidine and ings to conceal the sedative medication, and unblinded bedside nurses administered the propofol regarding long-term impairment. sedation to meet clinical targets. Of the 422 patients included in the analysis, 214 patients received dexmedetomidine at a median interventions of trial awakening and breathing, nondrug dose of 0.27 mcg/kg per hour, and 208 received propo- delirium interventions and early mobilization. fol at a median dose of 10.21 mcg/kg per minute. The Six months after randomization, researchers assessed median duration of treatment with the trial drugs was patients’ cognition with the Telephone Interview for Cognitive Status questionnaire and other validated tests for three days and the median RASS score was ‒2.0. For more than 90% of patients, the care team cognition, functional status and quality of life. adhered to the ABCDE bundle, performing regular continued on page 11 MISSION STATEMENT OF GSN It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Peter K. Kim, MD Bronx, NY

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GENERAL SURGERY NEWS / APRIL 2021

n this installment of Journal Watch, we look at two recently published articles in the trauma population evaluating institutional policy changes— one on universal screening of blunt trauma patients for cerebrovascular injury and the other on multimodal analgesia protocols to reduce opioid use. We also review findings from the FIAT trial evaluating anal fistula plug use for the management of fistula-in-ano, and long-term results from the SCANDIV trial assessing complications from laparoscopic lavage for purulent diverticulitis. The hope is that readers will find these topics worthwhile and relevant, and be able to use the findings to change and/or reinforce current practice.

Efficacy, Safety and Costs of Fistula-inAno Treatment: Plug Versus Surgery In the Annals of Surgery, Jayne and colleagues from the United Kingdom, on behalf of the Fistula-in-ano trial (FIAT) Collaborative Group, published their results evaluating the efficacy, safety and costs of using a fistula plug for the treatment of cryptoglandular transphincteric fistula-in-ano (Ann Surg 2021;273[3]:433441). This was a multicenter randomized controlled trial comparing the Biodesign Surgisis Anal Fistula Plug (Cook Medical) and surgical treatment of the surgeon’s preference. Treatments in the surgeon preference group included fistulotomy, cutting seton, advancement flaps and ligation of intersphincteric fistula tract (LIFT) procedures. The primary outcome was fecal incontinence quality of life (FIQoL), measured using a 29-question multiple-choice survey, administered before intervention and then six weeks, six months and 12 months after intervention. Secondary outcomes included incontinence, clinical and radiographic healing, reinterventions, complications, generic quality of life, and cost-effectiveness. In the study, 304 patients with cryptoglandular transphincteric fistula, involving one-third or more of the external anal sphincter, with a fistula tract of at least 2 cm, only one internal opening, and previously treated with a draining seton for at least six weeks, were randomized. There was no blinding of surgeon or patient to the intervention. All surgeons attended a surgical workshop on fistula plug insertion and had to have inserted at least three plugs before trial participation. There was a marginal improvement in FIQoL scores at 12 months after surgery in both groups, but the difference between the groups was not significant. At six weeks post intervention, there was a significantly higher rate of complications in patients with an anal fistula plug than the surgeon preference group (35% vs. 18%; P=0.002), mainly attributed to unexplained pain, as well as reinterventions (21% vs. 12%; P=0.03). At six weeks post-intervention, one-third of patients in both groups were clinically healed. At six months post-intervention, although not statistically significant, only 39% of the fistula plug group was healed, compared with 48% of the surgeon preference group. At 12 months, the clinical difference was negligible (54% for the plug vs. 55% for surgeon preference) and the radiological difference was not significant (49% plug vs. 57% surgeon preference) for healing. There was no significant difference in incontinence and generic quality of life between the two groups. Overall resource cost was significantly higher in the fistula plug group (£2,738 vs. £2,308; P=0.0174), which was attributed to the higher material costs of the plug. Treatment of high fistulas is quite challenging, and the authors provide further information into the effectiveness of a fistula plug. In the 2010 systematic review by Garg et al, the success rate of plugs ranged anywhere

from 24% to 92% (Colorectal Dis 2010;12[10]:965-970). There was no financial assistance from the device manufacturer. Although not powered to evaluate differences between procedures, fistulotomy appeared to have the most successful healing rates of all treatment methods and the LIFT procedure the worst. Limitations of the study include slow enrollment, requiring a reduction in the original recruitment goal of 400 down to 300 participants, such that results are powered to detect 98% moderate treatment effects and only 69% of small to moderate effects. Based on this evidence, fistula plugs appear to be a costlier, but safe and potentially better method of treatment than certain surgical treatments such as the LIFT procedure. As product cost decreases, so too should the cost of this treatment method.

Universal Screening Catches Cerebrovascular Injuries That May Otherwise Be Missed In the Journal of Trauma and Acute Care Surgery, Black and colleagues from the University of Alabama (UAB) provide guidance for the workup of patients with blunt trauma (Trauma Acute Care Surg 2021;90[2]:224-231). Current recommendations with the Denver criteria (DC) and Memphis criteria (MC) provide guidance on associated injuries to determine if evaluation of blunt cerebrovascular injury (BCVI) with imaging is necessary. After two trauma patients who did not meet BCVI screening criteria suffered strokes, UAB enacted a universal policy change to screen all patients with blunt trauma with CT angiography (CTA) of the neck. Using a retrospective review of blunt trauma patients after the policy change, the authors evaluated the true incidence of BCVI and examined the efficacy of current screening criteria. The researchers analyzed 6,287 adult blunt trauma patients with CTA of the neck. Independent review of imaging performed by two research investigators and

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 Surgery at the University of North Carolina at Chapel Hill School of Medicine —Column Editor

validated by neuroendovascular surgeons identified BCVI in 480 patients (7.6%). Data on 5,841 adult blunt trauma patients entered into the institution’s trauma registry were reviewed for associated injuries to evaluate the diagnostic performance of the DC, MC and expanded Denver criteria (eDC). With a sensitivity of 74.7%, the eDC had the best screening criteria to correctly identify patients with BCVI. However, it also had the worst accuracy and lowest positive predictive value (PPV) at 14.6%. The DC and MC fared better in PPV but had lower sensitivity. On screening criteria alone, use of the DC and MC would result in almost half of BCVI patients not being screened, and 25% if using the eDC criteria. The consequences of missed BCVI can be quite serious and the authors demonstrate the benefits of universal screening for BCVI. Current guidelines from associations such as the Eastern Association for the Surgery of Trauma and the Western Trauma Association recommend selective use of imaging for evaluation of BCVI. Limitations of this study include the retrospective nature of the data registry and the reliance on previously imputed data from the trauma registry to identify screening criteria. UAB is a busy Level I trauma center, whose patient population may not be generalizable to smaller institutions. A cost analysis of recommending increased imaging utilization was not performed. Nevertheless, the study provides compelling evidence that screening criteria alone may miss a significant proportion of patients with BCVI who have an increased risk for life-threatening consequences such as stroke and death.

Opioid Usage, Prescriptions Decreased In Trauma Patients Using a Multimodal Analgesic Strategy In the Journal of the American College of Surgeons, Harvin and other members of the MAST (MultiModal Analgesic Strategy for Trauma) Study group published the results of their randomized controlled trial ( J Am Coll Surg 2021;232[3]:241.e3-251.e3). This was a single-institution study from the Red Duke Trauma Institute, in Houston, enrolling adult trauma patients on arrival in the ER to one of two multimodal pain regimen (MMPR) arms: MAST MMPR which included scheduled acetaminophen, naproxen, gabapentin and lidocaine patches with as-needed opioids, or the original MMPR which used similar drugs as the MAST MMPR, but also included celecoxib, pregabalin and scheduled tramadol. The primary outcome measured oral morphine milligram equivalents (MME) per day. Secondary outcomes included total MME, incidence of opioid prescription upon hospital discharge, patient pain scores, complications based on the adapted Clavien-Dindo in Trauma (ACDiT) scale, continued on page 6

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GENERAL SURGERY NEWS / APRIL 2021

Breakthrough Studies continued from page 4

incidence of opioid-related complications and hospital length of stay. Over 12 months, 1,561 patients, with a median Injury Severity Score of 14, were included in the analysis. The two treatment groups had comparable demographics, medical comorbidities and traumatic injuries. When compared with the original MMPR group, patients in the MAST MMPR group had lower opioid exposure per day (34 vs. 48 MME; P<0.001), lower total opioid exposure (164 vs. 450 MME; P<0.001), and lower rates of discharge with an opioid prescription (62% vs. 67%; P=0.029). Of note, three-fourths of the MAST MMPR group discharged with a prescription were discharged with tramadol only. There was no clinically significant difference in pain scores, overall complications, opioid-related complications or hospital length of stay. Further analysis demonstrated specific trends based on unit of admission: surgical floor, intermediate care bed or intensive care bed. The authors provided a large sample of trauma patients and evidence that use of a multimodal, opioidsparing, analgesic strategy for trauma patients can lead to decreased use of opioids during hospitalization and after discharge. Limitations include the lack of tracking changes to pain regimens during hospitalization, and an inability to account for nonpharmacologic pain adjuncts such as heat/ice packs, physical therapy and patient education. Efforts to reduce opioid prescribing and finding Journal Article A multicenter randomized controlled trial comparing safety, efficacy, and cost-effectiveness of the Surgisis Anal Fistula Plug versus surgeon's preference for transsphincteric fistula-in-ano: the FIAT Trial.

both pharmacologic and nonpharmacologic adjuncts to manage pain in trauma patients are ongoing. The study provides a good blueprint for medical pain management to reduce the opioid crisis among adult trauma patients.

Severe Complication Rates Similar For Surgery, Laparoscopic Lavage For Purulent Diverticulitis In the February issue of JAMA Surgery, two randomized clinical trials—the LASER (Laparoscopic Elective Sigmoid Resection Following Diverticulitis) trial and the SCANDIV (Scandinavian Diverticulitis) trial— evaluated treatments for diverticulitis. In the multi-institutional study conducted in Sweden and Norway, Azhar and colleagues provide the five-year outcomes from their SCANDIV trial comparing laparoscopic lavage and primary sigmoid resection for emergency treatment of purulent diverticulitis with Hinchey stage less than IV (JAMA Surg 2021;156[2]:121-127). The primary outcome measured was disease- and/or surgery-related severe complications (Clavien-Dindo score >IIIa). Secondary outcomes included recurrent diverticulitis, secondary operations, stoma prevalence, functional outcomes, quality of life and mortality. Long-term follow-up was conducted via telephone interviews and using patients’ electronic medical records. Of the originally randomized patients, 142 (73 lavage, 69 surgical resection) were included in the five-year follow-up study. Severe complications, secondary reoperations (including stoma reversal), readmission rates, total

Key Takeaways • Use of the Surgisis Anal Fistula Plug is comparable to other surgical treatments for transsphincteric fistula-in-ano. • Material cost of the plug is the driver in increased cost for the procedure.

hospital lengths of stay, overall mortality, functional outcomes and quality of life did not differ significantly between the two groups. In the lavage group, 30% of patients eventually underwent sigmoid resection. The resection group had higher rates of stoma reversal (25% vs. 7%; P=0.003) and stoma prevalence (33% vs. 8%; P=0.002). The laparoscopic lavage group had more unplanned reoperations (26% vs. 12%; P=0.03), unplanned readmissions (34% vs. 11%; P=0.001) and diverticulitis recurrence (21% vs. 4%; P=0.004). A total of six patients (4.2%) were found to have sigmoid cancer (four, lavage group; two, resection group). With their long-term follow-up, the authors provide further information in a field where consensus has still not been reached. In recently published guidelines, the American Society of Colon and Rectal Surgeons strongly stated that “colectomy is preferred over laparoscopic lavage,” while the European Society of Coloproctology took a less emphatic stance, acknowledging that “lavage is feasible in selected patients with Hinchey III peritonitis.” Study limitations include possible selection bias in that fewer than half of eligible patients were eventually enrolled. Cost analysis to determine the financial impact of each treatment and evaluation to determine which patients may do best with laparoscopic lavage can further aid management decisions. Although these long-term results may not provide strong support for laparoscopic lavage, they do provide additional information to guide surgeons in how to counsel patients and treat purulent diverticulitis. ■

Words of Caution When Reading • Due to slow enrollment, the recruitment goal was reduced by the researchers. • It is unclear how the plug compares to specific surgical treatments. Multiple treatment methods were used by surgeons in the control arm and not powered to evaluate each treatment.

Useful Related Articles Garg P, Song J, Bhatia A, et al. The efficacy of anal fistula plug in fistulain-ano: a systematic review. Colorectal Dis. 2010;12:965-970.

Jayne DG, Scholefield J, Tolan D, et al; FIAT Trial Collaborative Group. Ann Surg. 2021;273(3):433-441. Universal screening for blunt cerebrovascular injury. Black JA, Abraham PJ, Abraham MN, et al. J Trauma Acute Care Surg. 2021;90(2):224-231.

• Over half of blunt cerebrovascular injuries (BCVI) can be missed if using selective screening criteria.

• The results from this single-institution, retrospective study may not be applicable to all institutions.

• Incidence of BCVI may be as high as 7.6% in all blunt multiple-trauma patients.

• Identification of screening criteria may be incomplete due to use of prior trauma registry data.

• Missed BCVI can have catastrophic consequences such as stroke and death.

Multi-modal analgesic strategy for trauma: a pragmatic randomized clinical trial. Harvin JA, Albarado R, Truong VTT, et al; MAST Study Group. J Am Coll Surg. 2021;232(3):241.e3-251. e3.

Laparoscopic lavage vs primary resection for acute perforated diverticulitis: long-term outcomes from the Scandinavian Diverticulitis (SCANDIV) randomized clinical trial. Azhar N, Johanssen A, Sundström T, et al; SCANDIV Study Group. JAMA Surg. 2021;156(2):121-127.

• Use of a multimodal pain regimen that minimizes reliance on opioids can reduce overall opioid use and opioid need after hospitalization. • Use of more expensive and/or medications not often covered by insurance such as IV acetaminophen, celecoxib and pregabalin were not required to reduce opioid use. • If pursuing nonoperative treatment, postoperative colonoscopy is necessary to rule out potential malignancy. • Severe complications, readmissions, total hospital lengths of stay, functional outcomes and quality of life were similar in both treatment groups after five years. • Of patients initially treated with laparoscopic lavage, 30% underwent surgical resection within five years.

Geddes AE, Burlew CC, Wagenaar AE, et al. Expanded screening criteria for blunt cerebrovascular injury: a bigger impact than anticipated. Am J Surg. 2016;212(6):1167-1174.

• Increased cost and health resource utilization with increased imaging was not evaluated. • Analysis was based on intent-to-treat and any changes in pain regimens during hospitalization were not recorded. • Study does not assess non-pharmacologic adjuncts such as positioning, ice/heat packs, physical therapy, cognitive-behavioral therapy and patient education as part of the pain regimen. • Only half of eligible patients were enrolled in the study, leading to possible selection bias. • Laparoscopic lavage was associated with more unplanned reoperations, unplanned readmissions and recurrences.

ACS Trauma Quality Programs Best Practices Guidelines for Acute Pain Management in Trauma Patients. www. facs.org/-/media/files/quality-programs/ trauma/tqip/acute_pain_guidelines.ashx

Hall J, Hardiman K, Lee S, et al. The American Society of Colon and Rectal Surgeons clinical practice guidelines for the treatment of left-sided colonic diverticulitis. Dis Colon Rectum. 2020;63(6):728-747. Schultz JK, Azhar N, Binda GA, et al. European Society of Coloproctology: guidelines for the management of diverticular disease of the colon. Colorectal Dis. 2020;22(suppl 2):5-28.

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The EEA™ Circular Stapler With Tri-Staple™ Technology: A New Standard in Colorectal Surgical Stapling Jorge Marcet, MD Professor of Surgery Director of Colon and Rectal Surgery University of South Florida Morsani College of Medicine Tampa, Florida

other immunosuppressants, such as those for the treatment of inflammatory bowel disease, can be at an increased risk for infection that can be exacerbated by an inadequate blood supply,” he said. Tri-Staple™ technology is designed to address these challenges and produce a more secure anastomosis while allowing for increased perfusion.4,5,a-c

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Advanced Surgical Stapling Advanced surgical staplers have undergone incremental improvement to address the major challenges to durable anastomoses in colorectal resections.1 The technology must be adaptable over a range of patient-specific anatomy, including tissue thickness.1 In more than 3,000 procedures ranging from excising malignancy to repair of damaged intestine due to diverticulitis or inflammatory bowel disease, Jorge Marcet, MD, a professor of surgery and the director of colon and rectal surgery at the University of South Florida Morsani College of Medicine, in Tampa, Florida, has used staplers to create anastomoses and restore bowel function for more than 30 years. Dr Marcet has used the EEA™ circular stapler with Tri-Staple™ technology, a circular device with 3 staple rows, since it became available in 2018. In that time, he has noted several distinguishing features and technical advances that ensure reliable performance across colorectal procedures (Figure 1). “It has revolutionized our ability to create low rectal anastomoses,” he said.

50% more security to the staple line without sacrificing healing.4,b Dr Marcet has seen an improvement in outcomes in his procedures. “My leak and bleeding rates with the EEA™ circular stapler with Tri-Staple™ technology are substantially lower than what has been reported historically,” he said.

Three Rows of Staples The predecessor to Tri-Staple™ technology is DST Series™ technology, which deploys 2 rows of uniform height staples. Tri-Staple™ technology, on the other hand, provides 3 rows of staples that vary in height (Figure 2).6,d It is available with a purple cartridge for medium/thick tissue, with staple heights of 3.0, 3.5, and 4.0 mm. For thicker tissue, the black stapler provides staple heights of 4.0, 4.5, and 5.0 mm. The staples closest to the lumen, the innermost row, have the shortest height, providing the greatest occlusion and barrier to leaks and bleeding.4,7,b,c The second and third rows, each incrementally higher, contribute strength to the closure line but reduce pressure on tissue to facilitate blood supply through the microvasculature.5,7,a,b That balance between occlusion and hemostasis is “the underlying principle of the EEA™ circular stapler with Tri-Staple™ technology,” Dr Marcet said. Internal manufacturer studies show that 3 rows of staples (vs 2) provide

The EEA™ stapler with Tri-Staple™ technology provides cues that can be seen, heard, and felt. Surgeons like Dr Marcet rely on that feedback to make informed choices in the midst of any number of operating room distractions. For example, the stapler’s handle delivers an audible and tactile click that tells Dr Marcet when the stapler has been completely fired.8,a,b Similar audible and tactile signals indicate when the stapler can be safely removed from the rectal anatomy.9,b,d Other cues provided by the EEA™ stapler also inspire clinical confidence. The sloped cartridge face is designed to direct tissue fluid away from the staple line when applying gradual compression. This feature reduces pressure on tissue when clamping.10,b,d-f “In addition, as the stapler is squeezed, there is tactile feedback which guides the surgeon in applying proper compression for pushing out the tissue fluid lateral from the suture line,” Dr Marcet said. “By tightening slowly, the gentle compression avoids placing too much stress when the stapler is fired. This improves perfusion during the healing process.”5,a,b

Controlling Leaks While Facilitating Perfusion Anastomotic leaks along the closure line can lead to infection and the potential failure of the anastomosis.2,3 Good apposition of the tissue with a secure closure during healing is therefore fundamental to the prevention of leaks.1,2 Since blood supply is critical to healing, effective closure must be achieved without excessive tension.1,3 In addition, according to Dr Marcet, some patients are at increased risk in wound healing, so it becomes particularly important to seek an optimal result in creating an anastomosis. “A substantial proportion of patients undergoing resection for rectal cancer have received radiation, which can damage tissue. Patients on corticosteroids or

GENERAL SURGERY NEWS • APRIL 2021

Figure 1. The EEA™ circular stapler with Tri-Staple™ technology.

Figure 2. The EEA™ circular stapler with Tri-Staple™ technology has 3 rows of varied height staples.

Supported by

Despite extensive stapling experience in the creation of anastomoses in colorectal surgery, Dr Marcet finds the feedback helpful for navigating key steps in the process. “These cues are helpful for indicating proper use of the stapler; they increase confidence and make the device easier to use,” he said.

Compared with Ethicon™ CDH circular staplers.

Bench test results may not necessarily be indicative of clinical performance.

Finite element analysis (FEA) was used to determine the strain profiles of three circular staplers during clamp-up. The EEA™ circular stapler with Tri-Staple™ technology demonstrated a graduated compression profile upon clamping.

Compared with Ethicon™ ILS circular staplers.

Firing Force

Upon removal of the stapler, examination of the proximal and distal sides of the excised tissue “donut” can serve as a useful gauge of procedural success.3 “The first thing a surgeon does after an anastomosis is open the stapler and evaluate the quality of that donut,” Dr Marcet said. “It can indicate the integrity of the staple line.” The EEA™ circular stapler with Tri-Staple™ technology was designed with a purse-string notch that is longer than DST Series™ technology, which allows the surgeon to reduce compression on the tissue when securing the purse-string suture so they can achieve desirable donuts that are larger and thicker. The anvil design accommodates more tissue and is integral to forming the desired purse-string closure at the suture line (Figure 3). “It allows the tissue to be squeezed around the anvil better than other stapler devices, which is important for creating a thicker, more uniform donut,” he said.

Figure 3. Cancer of mid-rectum with EEA™ circular stapler with Tri-Staple™ technology anvil and 2 intact anastomotic donuts.

Chekan E, Whelan RL. Surgical stapling device—tissue interactions: what surgeons need to know to improve patient outcomes. Med Devices (Auckl). 2014;7:305-318.

Tsai YY, Chen WT. Management of anastomotic leakage after rectal surgery: a review article. J Gastrointest Oncol. 2019;10(6):1229-1237.

Thomas MS, Margolin DA. Management of colorectal anastomotic leak. Clin Colon Rectal Surg. 2016;29(2): 138-144.

Data on file. Medtronic. Internal test report #RE00276578. EEA™ circular stapler with Tri-Staple™ technology compared to the top five DSTs circular staplers in the markets for number of staples in the circular staplers. June 24, 2020.

Data on file. Medtronic. Based on internal test report #RE00265643. EEA™ circular stapler with Tri-Staple™ technology perfusion study. July 2020.

Data on file. Medtronic. Internal test report #RE00069039. EEA™ circular stapler with Tri-Staple™ technology design verification report. December 2, 2014.

Data on file. Medtronic. Internal test report #RE00062609. CTC design verification test report. 2017.

Data on file. Medtronic. Internal test report #RE00073061. Tulip formative evaluation summary. November 25, 2016.

Data on file. Medtronic. Internal test report #RE00183973_B. Firing force and audible feedback test report. July 2020.

Photo courtesy of Jorge Marcet, MD.

reports extensive experience with a variety of staplers from a range of device companies, and although reluctant to draw conclusions about the relative performance of staplers that he does not routinely use, Dr Marcet said competing staplers do not share many of the key features of the EEA™ circular stapler with Tri-Staple™ technology that he believes contribute to his good results and are transferable to the creation of anastomoses in other anatomic sites. “I encourage colleagues to adopt the Tri-Staple™ technology,” he said.

Conclusion The goals of stapler design in the creation of anastomoses to restore bowel function following a colorectal resection are clear. The challenge has been to provide security at the staple line with minimal stress on the tissue, thereby preserving perfusion required for healing.1,3 For Dr Marcet, the cumulative effect of the design features of the EEA™ circular stapler with Tri-Staple™ technology is having the consistency with which early complications are avoided and healing is achieved across a broad range of indications. “The Tri-Staple™ technology represents a significant advance over 2-row staplers,” Dr Marcet said.

Reliance and Versatility Dr Marcet relies on the EEA™ circular stapler with Tri-Staple™ technology because of the technically advanced features, which he believes are the most currently available for use in colorectal surgery. He

Preclinical results may not correlate with clinical performance in humans. Compared with EEA™ circular staplers with DST Series™ technology.

10. Data on file. Medtronic. Internal test report #RE00200393. Comparison of circular staplers: tissue compression profiles as determined by 2-D static axisymmetric finite element analysis (FEA). August 2, 2018. Disclosures: Dr Marcet has received research support from Celgene; Epigenomics; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc; Recro Pharma, Inc; and Theravance Biopharma. He is a consultant to Medtronic and Stryker.

GENERAL SURGERY NEWS • APRIL 2021

US-ST-2100027

Donut Quality

References

BB211

Manufacturer testing indicates the firing force when using the EEA™ circular stapler with Tri-Staple™ technology is up to 62% lower than competing circular stapler devices.9,c,d Also, Dr Marcet notes the smaller grip that accommodates small as well as larger hands, a feature he thinks is important for the broader group of surgeons working with these devices. “In surgery today, an increasing number of women are performing the full range of procedures, including colorectal resections. The reduced firing force makes this device easier to use, which is relevant not just to women but as a general improvement over other devices,” he said.

IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2021

Taking the Lead: Advice for Female Surgeons By KAREN BLUM

As one of few female surgery fellows, Julie Freischlag, MD, FACS, said she frequently received questions from patients asking whether she was the surgeon, or whether she was allowed to operate. But one patient had tremendous confidence in Dr. Freischlag and gave her a bracelet that she still wears today. No matter what happens, female surgeons need to trust and define themselves as the surgeons they want to be, she said during an address at the Americas Hernia Society 2020 annual meeting. The COVID-19 pandemic has challenged everyone in trying to figure out how to continue to operate on patients who need surgery, said Dr. Freischlag, the CEO of Wake Forest Baptist Health, dean of Wake Forest School of Medicine, and chief academic officer of Atrium Health Enterprise, in Winston-Salem, N.C., during a keynote talk. Just as surgeons know what they’re doing in the OR, they need to project confidence in leadership in other areas, she said. Dr. Freischlag offered the following advice to women in surgery: Be transparent. Dr. Freischlag said she attributes part of her leadership success to being transparent, and telling people what she is doing. During COVID-19, her team had almost daily huddles, produced videos and had meetings to explain what they were doing and why. It’s also important in this process to focus on helping others, she said. “If you find a leader that you don’t particularly care for, it’s usually because they’re trying to help themselves and not the organization,” she said. “Despite how tough it is to be a leader, always make sure you’re helping others versus yourself, because as you do that, you will help yourself as you lead.” Be trustworthy. Only 48% of Americans said doctors provide fair and accurate information most of the time (Pew Research Center Report, January 2019), and only 12% said doctors take responsibility for mistakes. It’s really important to change that, Dr. Freischlag said. If there is a surgical complication with one of your patients, the No. 1 thing you need to do is be in the room all the time, she said. Trust is built in very small moments. As surgeons, you learn how to have tough conversations with patients, how to teach and how to give feedback to fellows and residents. Use those skills in leadership roles and tell people what you’re hoping for. Take the lead. Always raise your hand, talk at meetings, make comments, have an opinion and introduce yourself so that people know who you are and what you think. Like any personal relationship, the one between doctors and patients is a

complicated dance, knowing when to dip in versus pull back, Dr. Freischlag said: “But we can’t sit back and wait for others to lead us if we’re going to be active with inclusion and diversity.” About a third of general surgeons training in the United States are women, but they need to take on leadership roles in their communities, hospitals, departments and labs. “You can only change if you’re leading, not if you’re watching,” she said. Listen well and tell the truth. Most

of us don’t listen long. In fact, clinicians listen on average for 11 seconds before interrupting a patient (JAMA 2019;321[14]:1347-1348), Dr. Freischlag said. Listen a little bit longer and watch people’s cues before you make comments. And, always tell the truth. “Integrity is the No. 1 thing that people are going to judge you on,” she said. Do what you say, and say what you do. When you join a committee or take on a leadership role, do a great job. Do what

you say, and say what you do so people know they can count on you. Be an active bystander. If someone says something rude or inappropriate, determine how you will react. Speak up, and ask questions of people such as, “Did you really mean to say that?” You may have to wait until later and involve other key people to help. There are several ways to tackle microaggressions, from calling someone out to honestly saying someone’s words made you uncomfortable.

L I

IN THE NEWS

APRIL 2021 / GENERAL SURGERY NEWS

‘Despite how tough it is to be a leader, always make sure you’re helping others versus yourself, because as you do that, you will help yourself as you lead.’ —Julie Freischlag, MD, FACS

Remember your why. Always remember why you’re doing what you’re doing, she said. When it’s patient care, that’s pretty easy. But as a leader, it’s important to remember. “There are now quite a few women in surgery, but we tend to be white women, and we really need to get more women of color, international women and others into our wing,” she said. Consider becoming a leader in an area you consider important. Be nice. “I have a sign in my conference room that says, ‘Nice matters,’” Dr. Freischlag said. “Always be nice, be patient and be tolerant. … Take joy in

other people’s achievements, have total confidence in yourself, and make sure you continue to have the ability to give without undue thought of gain.” “There are many wonderful female surgeons working hard, and we all need mentors like Dr. Freischlag,” commented Vedra Augenstein, MD, FACS, a general surgeon with Atrium Health in Charlotte, N.C. “Her advice comes from experience and is shaped into specific points which will help anyone become a better professional. … Women are the largest minority in surgery, and our field is continuing to grow more inclusive across the board.” ■

Septic Sedation continued from page 3

About 25% of patients had clinically important cognitive dysfunction after sepsis, with no difference between dexmedetomidine and propofol in terms of long-term impairment. “It appears that sedation choice does not affect survivorship outcomes when currently recommended sedation approaches are used,” the authors wrote. Salman Ahmad, MD, an associate professor of surgery and the medical director of the surgical ICU at the University of Missouri, in Columbia, said the study findings are especially critical now, given limited resources and medication shortages across the country.

‘Many patients respond differently to each medication at different time points in their care, and I am more confident in switching between these medications if necessary.’ —Salman Ahmad, MD “Many patients respond differently to each medication at different time points in their care, and I am more confident in switching between these medications if necessary,” Dr. Ahmad said. The study’s limitations include unmasking episodes in 14% of patients and crossover in 10%. In addition, the trial drug was started a median of 22 hours after patients met the inclusion criteria, which may have limited the ability to affect outcomes. Investigators decreased the planned sample size due to slow enrollment, but said the study remains adequately powered. One-third of patients in the trial were surgical ICU patients. All were enrolled within one day of ICU admission and had a high severity of illness, a greater risk for acute respiratory distress syndrome and a higher requirement for con■ tinuous sedation.

IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2021

COVID-19 Registry Reveals Factors Leading to Increased Mortality Age, Need for Organ Support, Hospital of Admission Play Large Roles By CHRISTINA FRANGOU

ospitals around the world report wide variations in mortality rates for patients admitted with COVID-19, with a consistent pattern: Risk for mortality increases with age and need for organ support, according to results from a global registry. In February 2020, the Society of Critical Care Medicine and the Critical Care Research Network launched VIRUS (Viral Infection and Respiratory Illness Universal Study) to track hospital care patterns in near real time. Since then, 298 hospitals in 26 countries have joined, with data collected on 64,182 hospital admissions and 12,130 ICU admissions. This is one of the first large studies to evaluate outcomes among patients with COVID-19 according to a major prognostic factor: organ support required by patients. The hospital where patients were admitted made a difference to their outcomes. The risk-adjusted mortality rates for 4,749 patients who received invasive mechanical ventilation (IMV) ranged from 27.7% to 77.9%; a patient presenting to a hospital with poorer outcomes had a 1.69 odds of dying compared with a similar patient at a hospital with lower mortality. Amos Lal, MBBS, a critical care fellow at Mayo Clinic in Rochester, Minn., presented results at the 2021 Critical Care Congress Virtual Event. The paper was published in March in Critical Care Medicine (2021;49[3]:437-448). Approximately 10% of the variation in mortality is explained by the hospitals of admission, Dr. Lal said. “This presents an opportunity for quality improvement and for future studies to learn from practices at hospitals that achieved low adjusted mortality rates,” he said.

Many hospitals in the United States had lower mortality than other countries, but even within this country, mortality differed between hospitals. The effect of country was “a likely minor contributor” to mortality variation, he said. Dr. Lal and his colleagues studied patients admitted with COVID-19 at participating hospitals between February 2020 and November 2020. At the time, the registry included data from 179 institutions and 49,058 patients. Of these, 20,608 patients had complete outcomes data and were included in the analysis.

‘Remarkably, the mortality for those critically ill patients receiving ECMO is lower than some of the other subgroups, which probably reflects the selection of patients most likely to benefit from ECMO.’ —Greg Martin, MD Patients had a mean age of 60.5 years, 54.3% were men, and 50.4% of patients were white, 25.9% Black and 5.6% Hispanic; 85% had at least one comorbid condition and 42.4% required ICU admission. Overall, 19% of patients died. Patients younger than 45 years of age who did not receive organ support therapies were the least likely to die, with a mortality rate of less than 1%. Patients with the highest risk for death were those older than 74 who received IMV, vasoactive drugs and renal replacement therapy (RRT). In this group, 78.3% of patients died. At all ages, patients were more likely to die as they needed more organ support. Among patients placed on IMV alone, 40.8% died. Mortality rose to 71.6% for those who received IMV, vasoactive drugs and RRT.

Only 2% of patients in the registry received extracorporeal membrane oxygenation (ECMO). In this group, 35% died. “Remarkably, the mortality for those critically ill patients receiving ECMO is lower than some of the other subgroups, which probably reflects the selection of patients most likely to benefit from ECMO,” said Greg Martin, MD, the president of SCCM and a professor of medicine at Emory University, in Atlanta. Three-fourths of patients received no organ support. Of those who did, IMV was the most common method, used in 24.3%, either alone or in combination with other organ support therapies. Only 2.9% of patients (n=602) received vasoactive drugs and/or acute RRT without IMV. The VIRUS registry helps researchers and clinicians get a better understanding of what people and hospitals around the world are doing. They can share knowledge to improve quality of care, Dr. Lal said. It also helps answer questions from families concerning patients who present with an acute COVID-19 infection about expected outcomes, based on the organ support required, he said. “Our findings provide novel prognostic estimates for important patient-centered outcomes of survival and probability of discharge home across a wide range of ages and types of organ supportive therapies commonly required for patients with severe COVID-19,” he said. To date, of the nearly 48,000 patients included in the registry, 28% received IMV, while 13% and 2%, respectively, had noninvasive ventilation and ECMO. One in five received high-flow nasal oxygen and 10% were placed on dialysis. The median length of time that patients receive IMV is nine days; ICU stays last a median of seven days. Just over half (56%) of patients are discharged alive. The real-time dashboard of the VIRUS registry is ■ available at sccmcovid19.org.

Futile Trauma Transfers Uncommon but Costly By JENNA BASSETT, PhD

espite making up less than 2% of trauma transfers, unsalvageable patients present a significant cost burden to the health care system, researchers report. Researchers at the University of Kansas Medical Center (KUMC) investigated the rates and costs of futile transfers within their organization between June 2017 and June 2019. Futility was defined as a patient who had a stay that was no more than 48 hours that resulted in death, implementation of hospice care or discharge with no major operative, endoscopic or radiological intervention. Within the study period, there were 1,241 trauma transfers. Among the 407 trauma transfers with hospitalization time less than 48 hours, 18 patients (1.5% of the study population) were deemed futile. In both the futile and nonfutile groups, the majority of patients were transferred for traumatic brain injury

and the need for neurosurgical consultation or intervention. The researchers evaluated injury severity among transferred patients using the Injury Severity Score (ISS), a validated score that correlates with morbidity, mortality and hospitalization time after trauma. Scores above 15 indicate severe injury. Futile transfers were older, with more severe injuries as indicated by a median ISS of 21 versus 8 in nonfutile patients. Specifically, futile patients had more severe injuries to the head and torso. The median cost of treating futile patients was $56,396, and the total cost to the health care system exceeded $1.7 million during the two-year study period. The authors estimated that elimination of futile transfers would result in a cost savings of over $27 million annually in the United States. “Our study clearly has limitations in that our data represents the retrospective experience of a single institution serving a large network of rural referral

facilities,” explained presenting author Craig Follette, DO, a general surgery resident at KUMC, in Kansas City. “The data may not be able to be generalized to other trauma networks but could be compared to similar regional networks.” Dr. Follette also added that the study definition of futile was conservative, which may affect study conclusions, and the data do not show the intricacies of what occurs in the period surrounding a trauma transfer. “It is possible that patients received therapies not available at referral centers, although, in our experience, this would be extremely unlikely in the absence of ongoing consultant care.” To optimize trauma transfer, the researchers propose a new trauma transfer paradigm that incorporates a telehealth

support component that could be used to extend specialist support to critical access hospitals. “While beyond the scope of this paper, we believe that this future state will involve enhanced means of communication through telehealth/tele-trauma, and the overall sharing of Level I trauma center expertise beyond the walls of the center itself,” Dr. Follette said. “I believe the next step is collaboration with other centers in multicenter studies to truly define this special patient population and guide further resource utilization region by region.” The authors concluded that additional work is needed to avoid futile care and ensure appropriate allocation of health care resources to patients who will benefit. ■

IN THE NEWS

APRIL 2021 / GENERAL SURGERY NEWS

Overnight Telemedicine Services Reduce Mortality in ICU Patients continued from page 1

Foundation and lead author of the study. Dr. Udeh and his colleagues reviewed the cases of 153,987 patients who received ICU care at one of nine Cleveland Clinic hospitals between Jan. 1, 2010, and Dec. 31, 2019. Overall, 70% of ICU patients (108,482) received telemedicine care when an intensivist wasn’t on-site between 7 p.m. and 7 a.m. An off-site team of intensivists, acute care nurse practitioners and critical care nurses monitored and assessed patients remotely. Analysis showed that ICU patients who received telemedicine care were about 18% less likely to die, and spent 1.6 fewer days in the ICU and 2.1 fewer days in the hospital. In this study, researchers found that patients who were admitted on a weekend were no more likely to die than those admitted on a weekday, despite weekend admission being a known risk factor for death in an ICU. “Telemedicine offers an excellent means for providing a high level of care, allowing health issues to be discovered earlier and care moved along more quickly so that recovery can be as smooth and as swift as possible,” Dr. Udeh said. Today, about 15% to 20% of hospitals throughout the United States offer ICU telemedicine through an off-site command center. In some cases, ICU telemedicine is provided by an independent company or a different hospital system. From the telemedicine command center, tele-intensivists monitor a dashboard of patients at distant hospitals. Using real-time audiovisual two-way communication, the intensivist can see and speak to the bedside nurse and patient, and can observe various monitors tracking patients’ vitals. They can also call up medical records, x-rays and other test results. The software often includes decision support tools to help identify patients who may be sicker or are deteriorating. ICU medicine is particularly well suited to telemedicine because it’s physiologically based rather than requiring substantial hands-on provider–patient interaction, said Omar Danner, MD, an adjunct professor of surgery and the former chief of surgery at Grady Memorial Hospital for the Morehouse School of Medicine, in Atlanta. “It’s very plausible with critical care that you can access 95% to 99% of the information you need remotely and can guide the person who is at the bedside,” he said. As such, he was not surprised by the positive results reported in this study. Other studies are underway that examine outcomes for ICU patients with COVID-19 who received ICU telemedicine. Dr. Danner expects the studies will

Analysis showed that ICU patients who received telemedicine care were about 18% less likely to die, and spent 1.6 fewer days in the ICU and 2.1 fewer days in the hospital.

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also show a benefit for telemedicine, including a reduction in nosocomial infection rates. Telemedicine means fewer people are required to be in the room with patients with highly contagious infection. “The COVID-19 pandemic has challenged systems and now allowed us to also test telemedicine in the ICU. Telemedicine ■ does have its place,” he said.

GENERAL SURGERY NEWS / APRIL 2021

Guidelines for Avoiding Bile Duct Injury: Beware

I Preventing Bile Duct Injuries (Part 2): Should Cholangiography Be Required? n December 2020, we ended the year with a debate on the best way to prevent common bile duct injury after cholecystectomy. The debate raised as many questions as it answered. General Surgery News received several responses from its readers, but two stood out from the rest and their stances have prompted a new debate. This new controversy addresses whether a stilldebatable solution should be mandated to surgeons in some way. Our debaters not only differ in their solutions to the problem of common bile duct injury, but how, and whether, any solution should be enforced. Because I believe the latter raises important ethical and political questions that we all need to face, we are continuing the debate on prevention of these injuries. How we as individual surgeons, as surgical societies, and the general public proceed in solving this important question is the subject of this month’s debate. I am sure that you will find what each of our debaters is saying to be their honest opinion, but I am also sure you will pick a side to vehemently support. “Read ‘em and weep,” and don’t hesitate to carry on the debate. We surgeons need to be the ones guiding our future path, not some outside institution or enforcement body.

Edward L. Felix, x, MD Editor, The Great Debates bates General Surgeon, Pismo Beach, Calif. if.

Send comments about this debate or ideas for future debate topic to khorty@mcmahonmed.com.

read with interest the Great Debate in the certainty. I’m only using this as one example, December 2020 issue of General Surgery but it sets the stage for my concern. The ramNews between Drs. L. Michael Brunt, Taypant use of consensus conference panels and lor S. Riall and Raul J. Rosenthal on the use “guidelines,” as they are so innocently labeled, of intraoperative cholangiography (IOC) to is out of control in our profession. These decrease major bile duct injury (BDI) durguidelines can create many issues for both ing laparoscopic cholecystectomy. Dr. Brunt practicing surgeons and surgical trainees, and stated it should always be used; Dr. RosenI think this is especially true of the consensus Guy Voeller, thal said we should always use fluorescent conference on the prevention of BDI. MD, FACS indocyanine green for IOC; and Dr. Riall One cannot help but be amazed how “recProfessor of Surgery, said it best when she concluded her arguommendations” can be made as they are in ment: “An individual surgeon’s algorithm in University of Tennessee this 22-page manuscript by the consensus this challenging setting [anatomic clarity Health Science Center, conference panel with such little evidence Memphis is not achievable] should be consistent and to support the recommendations. The panel based on their expertise.” describes 18 recommendations that they I would like to broaden the discussion and talk about suggest surgeons should “possibly” do as part of their something Dr. Brunt mentioned in his argument: the approach to laparoscopic cholecystectomy. They conmulti-society practice guidelines and state-of-the-art clude the paper by admitting the quality of evidence is consensus conference on the prevention of BDI dur- low—usually Level IV—for almost everything that was ing cholecystectomy. For those of you not familiar with recommended. this consensus conference, I urge all of you to read the More importantly, and what I see as dangerous, the lengthy manuscript (Ann Surg 2020;272[1]:3-23; Surg authors say the guidelines—with very low level of eviEndosc 2020;34[7]:2827-2855). dence—will be disseminated and promoted on differThis consensus conference has been used, as Dr. Brunt ent society websites, through panel sessions at various used it for IOC, to advocate for certain practices dur- meetings, translated for international audiences, and ing laparoscopic cholecystectomy. I applaud his efforts promoted through social media. Scarily, they say the and the hard work of his committee to limit major BDI, guidelines should be distributed to hospitals, health but even he admits that most of the studies used to rec- care systems, health care plans, malpractice insurers and ommend routine IOC are of very poor quality. As Dr. patient safety organizations. Finally, they say they will Riall also pointed out, the evidence that the members of disseminate these guidelines into general surgery trainthe conference used to recommend IOC had very low ing programs throughout the world to influence the

Cholangiographic Activism

f the leaders of organized surgery are intent on surgeon would do in the same or simireducing the number of bile duct injuries durlar circumstance. Since approximately only ing laparoscopic cholecystectomy, they must take 20% of surgeons employ routine IOC, it is illogical and untenable to state that 80% of a novel approach. The silos of the congress/conthe surgeons are violating the surgical stansortium/national meeting and focus group have dard of care by failing to perform this study. kept emerging information among themselves. Despite the increasingly convincing data It is time to involve and effectively use the most Leo A. Gordon, that IOC detects and prevents injuries, the important element of the equation: the patient. MD, FACS working surgeon, confident in the delineaPatients must become an activist group camSenior Consultant tion of the biliary anatomy, is still legally paigning against bile duct injuries (BDIs), just in Clinical Surgery, within the standard of care if that surgeon as they have for other disease entities. They Surgery Group LA, does not routinely perform IOC. must become intraoperative cholangiography Surgical leaders must go beyond the con(IOC) activists. They must entreat their physiLos Angeles fines of the traditional methods of exchangcians to use IOC “on a routine basis.” An increasing amount of peer-reviewed scientific ing scientific information, and they must head in a new data from around the world strongly suggest that rou- direction. Only then will a scientifically valid principle become an element of the surgical standard of care. Just tine IOC during laparoscopic cholecystectomy will: 1-8 as laparoscopic cholecystectomy became patient driven, • prevent biliary tract injuries ; so too should routine IOC. This is called cholangio• detect injuries to the biliary tract at the time of graphic activism. surgery; and A five-step program promoting the universal adop• lessen the consequences of a biliary tract injury by tion of routine IOC as part of laparoscopic cholecystecits detection at the time of surgery. tomy may achieve this goal. At this point, one still cannot say with clear and convincing scientific justification that performing IOC should be a requirement of the surgical standard of care. 1. Surgical Education Programs If surgical educators are convinced of the efficacy of As other surgeons have pointed out, there is a difference the routine use of IOC in preventing BDIs, such use between the surgical standard of care and what is advoshould become a required part of all surgical educacated as safe and effective by researchers. “Standard of tion programs. The professoriate and master educators care,” a term loosely used at many surgical conferences, should adopt this approach to institute the universal use is a legal and not a medical term. A commonly accepted of this technique by incorporating it into laparoscopic definition of standard of care means what a reasonable

GREAT DEBATES

APRIL 2021 / GENERAL SURGERY NEWS

next generation of practicing surgeons. Unfortunately, some of this has already been done. As someone who performed the first laparoscopic cholecystectomy in my area and who, over the past 33 years, has performed around 5,000 of these procedures without a major BDI, and who regularly serves as an expert on such malpractice cases, I am very concerned about the dissemination of so-called guidelines as a consensus with very low to no level of evidence to support them. I will cite a few examples. The first recommendation regards the critical view of safety (CVS) to mitigate BDI. The panel begins by saying there is no direct comparative evidence to support the CVS over other methods for anatomic identification during laparoscopic cholecystectomy, but they still recommend its use. Now, I am not here to criticize the CVS. However, there are many issues with the CVS, and when it becomes a “guideline,” since we know that lawyers and hospitals and others will equate it with the standard of care, which to them means the only way to do lap chole, and therein lies the issue. I have seen this many times in the majority of lap chole cases I have reviewed as an expert witness. The CVS is the favorite tool plaintiffs’ attorneys hold up as being the standard of care, and they believe it is the only way to expose the critical structures during lap chole. This leads to the second recommendation of the panel that when the CVS cannot be achieved, laparoscopic subtotal cholecystectomy should be done over total cholecystectomy by the fundus-down approach either by a laparoscopic or open technique. As someone

If patients are made aware of the numerous scientifically proven benefits of IOC, they will start demanding it during their preoperative discusion with surgeons. cholecystectomy training. Department chairs should require routine IOC during laparoscopic cholecystectomy within their departments. They must, through their instruction and supervision, make it a required part of the operation. National organizations dedicated to surgical education, such as the Society of American Gastrointestinal and Endoscopic Surgeons, the American College of Surgeons and the Society for Surgery of the Alimentary Tract, must also publicly promote this concept. 2. The American Board of Surgery It is the obligation of the American Board of Surgery to certify surgeons who are safe. If the members of the board are convinced that routine IOC is part of a safe surgeon’s activities, it is their ethical duty to promote routine IOC through the examination process. If the board failed every candidate who did not perform an IOC procedure with every laparoscopic cholecystectomy, then every candidate would perform—or would say they would perform—this procedure in an examination situation. If the answer on the written exam and oral exam were to perform routine IOC, the seed would be planted among the candidates: that to pass the

who has successfully done thousands of laparoscopic fundus-down or retrograde dissections in impossibly diseased gallbladders, I find it sad that what the panel recommends has a very low level of evidence. In fact, I write this after completing three lap choles today: Two of them had impossible chronically diseased gallbladders wherein no normal tissue planes were evident such that the triangle of Calot could not be safely dissected. However, with a lot of hard work and a retrograde approach, both cases were accomplished safely laparoscopically. If we had followed the guidelines of the committee, both of these patients would have had a suboptimal operation—such as subtotal cholecystectomy or fenestration—and be faced with long-term problems. I will let the readers review the rest of the manuscript to see that this low level of evidence permeates most of the recommendations. This is not to say there is not plenty of information in the panel’s work, but as with most guidelines, the creators seem to ignore the serious weaknesses and plan to promote their recommendations as fact on a worldwide basis. Laparoscopic cholecystectomy is a common operation and can be easy or extremely difficult, which is true for most surgical procedures. We all know that major BDI can be catastrophic for the patient and the surgeon. I applaud all the difficult work done by the committee in trying to make the procedure as safe as possible. I am not trying to say the information evaluated is not important, and I am not saying important information for the practicing surgeon does not

examination, that this is the only correct answer. Once it is known that the American Board of Surgery is convinced that the weight of scientific research favors IOC, examination candidates will respond appropriately. 3. Medical Liability Companies Medical liability insurance companies are seeing an increased incidence of claims filed because of BDIs (personal communication, 2017). The litigation costs of a BDI are significant. If one considers the filing of the case, the evaluation of a case by experts in the adjudication of the case, the average insurance company spends approximately $100,000 to $150,000 in case evaluation alone. Should the plaintiff prevail by settlement trial or arbitration, the typical judgment is about $300,000 or more, depending on the economic damages and gender. In states with no financial cap on pain, suffering and emotional distress, this number may be significantly increased. Medical malpractice insurance companies should offer a tantalizing premium discount for all surgeons performing laparoscopic cholecystectomy. 4. Hospitals Hospitals and medical centers, through their credentialing and reappointment processes, often bear part of the litigation expense for BDIs. If IOC becomes the standard of care for biliary surgery, it follows that they will be held partly responsible for such injuries. If hospital administrators are made aware of potential cost savings by avoiding payments or eliminating payments for

As with most guidelines, the creators seem to ignore the serious weekness and plan to promote their recommendations as fact on worldwide basis. result from these panels. It is the way this information is used, conveyed and disseminated that needs to change. The committee mentions some of these issues in their manuscript, but in their haste to seal in stone their recommendations based on flimsy evidence and to disseminate them widely, they seem to gloss over the fact that much work needs to be done to find out if their guidelines have any basis in fact. The rigidity, oversimplification, and what I see as a sort of arrogance in these recommendations and their inflexibility to entertain what goes on in the real world, may show the difference between the academic surgeon who does 10 to 20 lap choles a year and the practitioner in the real world who does 150 a year. I work in two busy community hospitals where thousands of gallbladders are safely removed each year. There will always be the risk for BDI in lap chole— it is the nature of the beast. There is no such thing as a “never event”—don’t get me started on that idiotic phrase—when you are dealing with a complex human being with a diseased gallbladder and surgeons with varying experience and abilities. It is time to reel in the guideline madness for the benefit of all concerned.

BDIs, this will have a powerful effect on adopting its use. By including a requirement that if laparoscopic cholecystectomy privileges are awarded to the applicant, IOC must be part of the procedure and IOC must be used at that particular hospital. The technology to perform IOC is already available in most hospitals. Surgical leaders and master surgeon educators concerned with the BDI issue also should consider a bold move: lobbying state legislators to add BDI to the evergrowing list of “never events,” such as wrong-side surgery. Some of these events carry with them significant administrative monetary penalties for the hospital in which these cases arise. 5. The patient as an IOC advocate—IOC activism If patients are made aware of the numerous scientifically proven benefits of IOC, they will start demanding it during their preoperative discussion with surgeons. Patients are becoming increasingly sophisticated as they approach their procedures. As such, a direct appeal to the public by medical organizations will have a lasting effect on the adoption of routine IOC during laparoscopic cholecystectomy. The adoption of routine IOC will re-create the dynamic that arose with the introduction of laparoscopic cholecystectomy in the first place. The circa 1990 query, “Do you do the new type of gallbladder surgery?” will now be replaced by, “Do you do the x-ray of my bile ducts during the operation?” Cholangiographic activism may be historically continued on the following page

GENERAL SURGERY NEWS / APRIL 2021

Great Debates continued from the previous page

viewed as the biliary equivalent of handwashing. Just as handwashing and the mass dissemination of scientific information led to fewer infections, so too may routine IOC decrease the incidence of BDIs and the problems arising from such injuries. The data are there. It’s now up to the leaders of surgery and master surgical educators to embark on a plan to weave that data into the fabric of surgical practice. Until a future technology can reliably and objectively delineate the biliary tree intraoperatively, the scientific argument for routine IOC will remain persuasive. When every reasonable physician in the same or similar circumstance performs routine IOC, the goal of IOC activism will have been achieved.

Dr. Voeller’s Response to Dr. Gordon Dr. Gordon is a well-respected and wonderful surgeon and writer, but he seems very frustrated by, and cannot understand, why only 20% of surgeons employ IOC routinely. It seems to me with these numbers, that selective IOC is the standard of care today in the United States, and that angers him. He apparently did not read the safe cholecystectomy guidelines on IOC wherein the “experts” trying to force these “guidelines” down our throats admit the evidence that IOC prevents BDI had a very low level of certainty. He even admits that at this point, “one still cannot say with clear and convincing scientific justification that performing IOC should be a requirement of the surgical standard of care.” Thank God for that. Dr. Gordon suffers from the same arrogance and rigidity that the BDI consensus conference exhibits by saying he knows better, and since the majority of surgeons are not routinely doing IOC, we must force you to do so because we experts know best. If Dr. Gordon gets his way, the “authorities” will be coming at you from every direction to force you to do something that has a very low level of evidence that it will prevent major BDIs—regardless of when he says several times that the scientific evidence “proves” the benefits of IOC. All surgeons want to do the best operations for their patients. IOC is an important tool. I think it is important to realize that major BDI occurs in only 0.3% to 0.5% for all laparoscopic cholecystectomies. I think it is a credit to all practicing surgeons that the incidence is so tremendously low. As someone who has done around 5,000 lap choles in the past 30 years with

no BDIs and is a selective cholangiographer, what Dr. Gordon wants to force on me with his five-step manifesto will be of little benefit to my patients, and many practicing surgeons with similar results feel the same way.

Dr. Gordon’s Response to Dr. Voeller

Unfortunately for the patients of the world, there are not a million Professor Voellers to be teleported into ORs. Anyone who can pound out an essay about “guidelines” after a day full of three tough laparoscopic cholecystectomies on the heels of 5,000 cases without a BDI has to be heard. The truth is that most surgeons, such as this writer, are well-qualified work-a-day surgeons who comprise the bulk of the bell curve of surgical expertise. I yield to Dr. Voeller’s surgical expertise; I do not yield to his References opinion. The largest cohort of surgeons—those of us who 1. Berci G, et al. Am J Surg. 1991;161(13):355-360. dwell in the middle of that bell curve—should attempt 2. Carroll B, et al. Surg Endosc. 1996;10(3):319-323. visualization of the extrahepatic biliary tree to guide 3. Flum D, et al. JAMA. 2003;289(13):1639-1644. dissection and to assure themselves that nothing has 4. Waage A, et al. Arch Surg. 2006;141(12):1207-1231. been injured during a laparoscopic cholecystectomy. Although not “standard of care,” routine IOC should 5. Roberts I, et al. J Gastroenterol Hepatol. be attempted during every laparoscopic cholecystecto2009;24(5):762-769. my. Refining the techniques of catheterizing the cys6. Buddingh KT, et al. J Am Coll Surg. tic duct, securing the catheter in place, stabilizing the 2011;213(2):267-271. operative field, intraoperative discussions and observa7. Alvarez FA, et al. Br J Surg. 2014;101(6):677-684. tions of the common duct, emptying mechanisms, and 8. Brunt LM, et al. Surg Endosc. 2020;34(7):2827-2855. contour of the biliary tree all contribute to increasing surgical expertise, particularly when surgical residents Dr. Gordon is a member of the editorial advisory board of are involved. A memorialized picture of the biliary tree General Surgery News. confirms the safety of the dissection up to that point in the operation. Even in the smallest hospitals, the cathPRODUC T ANNOUNCEMENT eters are available. There is a C-arm used in the orthopedic room. X-ray technicians may Arthrex Launches SynergyID™ Multispecialty Surgical Video System be summoned. We should use these tools. The skills acquired while performing IOC The SynergyID™ system represents the next generation of leading-edge, multispecialty surgical are adaptable to other areas of surgery— visualization technology, including the world’s first four-chip camera head open, laparoscopic and robotic. For most of us without the surgical skills of Dr. Voeller, the “suboptimal” operation of subtotal cholecystectomy has been a useful alternative. Most people would rather have a retained portion of a gallbladder potentially necessitating a second operation than a BDI necessitating a Roux-en-Y hepaticojejunostomy at the university with a lifelong risk for stricture. I agree sincerely with Dr. Voeller’s views on guidelines. Guidelines are organizational flavors of the month. I read the consensus conference report on BDI to which he refers. I did not find this summary to be rigid, oversimplified, inflexible or arrogant as Dr. Voeller states. The document is a general summary of the issue—a sincere, hardworking attempt to solve an ongoing surgical (NAPLES, Florida) – Arthrex, a global leader in minimally invasive orthopedic technology, is pleased to problem. announce the launch of the SynergyID™ surgical video system. The SynergyID™ system represents I also agree with his disdain for the term the latest advancement in multispecialty surgical imaging technology by combining state-of-the-art 4K “never event.” It’s the old saw: “Never say never.” Unfortunately, that term is ingrained visualization with superior augmented reality features, such as near-infrared fluorescence imaging. in the patient safety lexicon and will never go away. For more information about the SynergyID™ system, visit: synergy.arthrex.com. Most of us will never achieve Dr. Voeller’s At press time, SynergyID™ has been CE Marked and FDA clearance is pending. level of expertise, so we must rely on adjuncts For real-time regulatory updates, please visit synergy.arthrex.com such as IOC to get us through to safely ply ■ our craft and avoid BDIs.

OPINION

APRIL 2021 / GENERAL SURGERY NEWS

When She Is Your Own By AMITABHA GHOSH ROY, MD

y sister, Nadi, at age 89, was living a full active life in Kolkata, India, when she suddenly fell ill. She became very weak with a lack of appetite and vomiting, and she developed a puffy face. She was admitted to the hospital, where the pertinent lab values showed thyroid-stimulating hormone over 100, sodium of 101, a high white blood cell count with 95% polymorphonuclear leukocytes, and a high C-reactive protein level. She was near comatose, hypotensive and required pressors. Amazingly, she quickly improved with her lab values returning to normal, and she was taken off the pressors—but not for long. She developed severe respiratory failure with oxygen saturation in the 70s, carbon dioxide in the 60s and labored breathing. She was unable to clear the secretions in her throat that were choking her. Chest x-ray and CT showed bilateral fluffy infiltrate and left lower lobe collapse. Urgent intubation and bronchoscopy were recommended.

It was up to me to make the enormously critical decision to intubate or not—to let my sister live or die. As I pondered what to do, I suddenly looked at my sister. Her face was ashen gray, cold and sweaty, and she was struggling for a drop of air. She looked to me, desperately with bulging eyes, for help. It was up to me to make the enormously critical decision to intubate or not—to let my sister live or die. Could I deny her the life for which she had fought so valiantly to overcome the metabolic insult to the point that she was able to talk, albeit ever so feebly? Her pleading face said it all, and she was intubated. Over the next couple of days she improved, and she was extubated. But unable to cough up sputum, she was gasping and begging for air again, with bulging eyes. She desaturated quickly, raising the question of reintubating her or letting her die. I approached her with a gentle suggestion of intubation. She said no. With a heavy heart and trepidation, I told her that she would die without intubation. She consented and was reintubated. My mind was occupied with the thoughts of another failed intubation, with the need for tracheostomy and all the associated problems. But when I found a moment to reflect, I thought of Nadi’s unexpressed fears of reintubation:

the extreme discomfort of the tube being in her mouth strapped to her face, the tie going right through her mouth and cutting the lips, being unable to speak, and begging for, but being denied, a sip of tea which she loved, or even a drop of water. When her nieces Skyped from 10,000 miles away in the United States, she touched the screen of the iPad and caressed them.

Her condition deteriorated and I brought her home where she had always said she wanted to die. Surrounded by her family, she nodded, letting us know that she sensed that she was home. She passed away peacefully in the arms of her stricken, loving family. Nadi was then taken to the crematorium on that same day, placed in the furnace, and I could see the huge flames engulf her as the door was shut. I saw the small heap of ash outside the furnace and

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that was all that remained of my wonderful sister, Nadi. The thought that haunts me today is whether I made the correct decisions to intubate and reintubate my dear sister. If I had been her physician and not her physician brother, I wonder if I would have made the same decision. The decision-making process becomes unclear when the patient is one of your own. ■

OF THE TIME.1 †Contamination was found following disassembly of the devices and jaws. The study found that 52% of reprocessed devices studied had visible contamination. The remaining 48% did not have contamination that was visible to the naked eye. ‡The combination of failed tests included visual inspection, optical and scanning electron microscopy, hemoglobin detection, and sterility testing. §Sterility assurance level of 10-6 accepted by the FDA as laid out in the Association for the Advancement of Medical Instrumentation (AAMI) standards ST67 and TIR 12 for devices contacting normally sterile tissue.

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LETTER TO THE EDITOR

GENERAL SURGERY NEWS / APRIL 2021

Public Perceptions: The Role of Residents in Operations is a sobering reminder of how the past continues to profoundly influence the present (J Cult Divers 2007;14[2]:5660; J Health Care Poor Underserved 2008;19[4]:1168-1180). Dr. Greene nicely outlines some important endeavors that the surgical community can take to help counter misinformation and to recruit patients as our allies in the quest to enhance graduated residents’ autonomy in surgery training. I believe that building a foundation of

To the Editor: The issue brought to light by the article in the Journal of the American College of Surgeons (2021;232[1]:8-15.e1), cited in Dr. Frederick Greene’s editorial, “Public Perceptions” [March 2021], is critically important to surgical education today. Although I questioned how the authors achieved a 93% response rate, the results are very significant and raise an issue that should be addressed by the Association of Program Directors in Surgery, the Accreditation Council for Graduate Medical Education and the American College of Surgeons. The world we live in today is not the world of the 1970s and 1980s, during which many older surgeons in positions of leadership trained. And the public is not the same public with the same expectations. I believe that we as surgical educators can, and should, do better to educate the public and address their issues. Over the years that I trained residents, I made it clear to my patients that residents worked with me and would usually be in surgery with me. If they would not allow that, I would offer them another surgeon. Joseph B. Cofer, MD, FACS Chattanooga, Tenn.

To the Editor: I read Dr. Greene’s recent editorial on public perceptions of residents’ participation in surgical procedures with great interest. Thank you for using your platform to further the conversation on this critical issue in surgical education. The study by Dickinson et al reveals that the surgical community has a lot of work to do with regard to patients’ perceptions of residents’ role in their operations (J Am Coll Surg 2021;232[1]:8-15. e1). The findings on multivariable analysis that females, Blacks, Hispanics and uninsured are more likely to never allow resident participation in their surgeries

trust with our patients is the fundamental step in this effort. As attending physicians, if our patients trust us to have their utmost interest, then they would know and understand that resident participation in their case is not a dereliction of duty to the patient. We can gently remind our patients that what our residents are today, we were months or years ago, and it is through graduated responsibility that we become safe and independent surgeons. We can remind and

reassure patients that as the attending surgeon, we are ultimately responsible for their care and therefore we allow appropriate resident participation in cases because it is safe. We can, and should, remind ourselves to be fair and mitigate bias (conscious and unconscious). If we would allow a resident with the appropriate skill level to participate in critical portions of a case on ourselves or family members, then we should genuinely offer that assurance to patients who may have

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LETTER TO THE EDITOR

APRIL 2021 / GENERAL SURGERY NEWS

hesitations. When patients report their gratitude for exemplary service by a resident, we should share those stories with the public. While we have some objective data to show that resident participation in cases does not increase complication rates (J Am Coll Surg 2019;229[6]:621-625), this campaign to alter the public’s perception is unlikely to be won with data alone but rather a multifaceted approach to include dialogue, personal stories and relationships. Elliot A. Asare, MD, MS Salt Lake City

To the Editor: Your recent editorial, “Public Perceptions,” triggered a lively conversation with my wife who owns and directs a very busy OB-GYN practice. Although we both trained in academic centers, we now work in the community setting and have frequent exposure to residents, advanced practice nurses and physician assistants. We are glad you addressed this issue because we believe it’s the tip of a big iceberg—the erosion of public trust in professionals and others with designated authority. Your timing is excellent because admiration and trust in

the medical profession seems to have been given a lift during the pandemic, despite anti-scientific and anti-intellectual undercurrents in the nation’s public discourse. As ones who enjoy history and often seek answers from it, we don’t recall the issue “Who is doing the surgery?” rearing its head often during our own residency training some 40 years ago. I think of the surgeons of greatest stature with whom I worked, and cannot imagine the question coming up out of respect for the surgeon who had the responsibility for care. At a five-star restaurant, we couldn’t imagine

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PRECAUTIONS (Continued) 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):506512. 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):9991009. 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. © 2019 Allergan. All rights reserved. STM122131 03/19

inquiring of the maitre d’ who actually grilled my entrecote de boeuf au poivre. I’m sure the skepticism of some patients and families arises because of nonverbal communication that occurs despite clear verbal communication about the nature of the procedure and the designation of tasks. There is something to be said for the importance of a surgeon’s gravitas, something that we believe has been slowly eroding over the past 40 years. The rushed, sloppy and illpostured appearance, the distracting tug of pagers and phones, the poor choice of venue for discussion, the residents shuffling in the background—none of these are likely to foster a sense of reassurance and trust. When people are anxious, their sense of annoyance is heightened by these seemingly minor things. My best mentors demonstrated a generosity of spirit and collegiality toward the resident who would presumably perform the anticipated procedure. They conveyed their personal sense of confidence in the resident. One attending of mine put it, “I wouldn’t seek fashion advice from Dunn, but I would trust him with my life!” The experience that made me want to be a surgeon was when, as a college student shadowing my father, I observed the enormous look of relief on the face of a desperately ill patient elicited by his calm, undistracted presence at the bedside before any inquiries or discussion had occurred. He conveyed a sense of total focus on the problem and the person leaving the impression that if he couldn’t fix it, no one could. I wanted to be that person. If he had said, “My resident will be doing the surgery under my direct supervision,” there would have been no qualms. As far as the institutional response, I agree the American College of Surgeons can do more to clarify to the public the concept of graded responsibility, perhaps as it has been done in the military—each year of postgraduate training has pegged with it certain procedures for which the resident is “rated" to perform competently with or without attending supervision. This could be posted or distributed. I also agree that the public needs to learn that the pipeline of competent surgeons will be cut if residents don’t have experience and self-confidence. It’s the public’s side of the bargain to accept this. The public has just had a warning about the danger of the limited availability of trained medical personnel, and it may now be receptive as it recognizes the importance of our covenantal relationship with it. Geoffrey P. Dunn, MD, FACS Erie, Pa.

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IN THE NEWS

GENERAL SURGERY NEWS / APRIL 2021

Bariatric Complications continued from page 1

‘Everyday’ Operations in Complicated Patients Peter E. Fischer, MD, MS, an associate professor of surgery at the University of Tennessee Health Science Center, in Memphis, is not a bariatric surgeon, and his hospital, Regional One Health, doesn’t have a bariatric program. “But these patients still show up in our emergency department [ED], as I’m sure they show up in yours, and there are ways to walk through general surgery issues.” Some of the reasons post-bariatric patients arrive in the ED have nothing to do with their bariatric surgery. “Just because they had bariatric surgery doesn’t mean they don’t have appendicitis,” Dr. Fischer said. Other conditions, such as gallstone disease, may be more prevalent in patients who have undergone bariatric surgery but are still fairly common in the general population and familiar territory for general surgeons. But people who have undergone bariatric surgery can present unique challenges; it’s wise to get a comprehensive history: What type of bariatric procedure did they have and when, how many operations since then, and who did their procedure? “These can be complicated consults and complicated patients, and continuity of care is important,” Dr. Fischer said. If the bariatric procedure was conducted recently, within the last six months, or if the patient is experiencing an early complication specific to bariatric surgery, he advises trying to send the patient to a bariatric specialist: “ideally the surgeon who performed their procedure,” he said. Otherwise, general surgeons are equipped to handle the needs of most post–bariatric procedure patients. As Raul Rosenthal, MD, said, “The acute abdomen belongs to the surgeon on call.”

Early Complications Early complications are major complications, and should be treated by a

bariatric surgeon. The two early complications that occur after Roux-en-Y gastric bypass are bleeding and leaks; they are distinguished from each other by heart rate. “When patients develop a leak, they will have sustained tachycardia, above 120 [beats per minute] regardless of pain medication or antibiotics. But when the patient has a bleed, their heart rate doesn’t just go up; it also becomes very cyclic, from 80 to 120 to 90 to 110,” said Dr. Rosenthal, the chief of minimally invasive and bariatric surgery at Cleveland Clinic in Weston, Fla. Bleeding occurs in about 4% of patients. Surgeons first need to determine whether the bleeding is intraluminal or intraabdominal, and then identify the bleeding site, whether from anastomosis, staple lines, mesenteric defects or trocar sites. “Patients should be transferred to a monitored setting; surgical decision making depends on clinical signs and symptoms,” Dr. Rosenthal said. Leaks occur after about 1.7% of Rouxen-Y gastric bypass procedures; the treatment is drains, drains and more drains. “If the patient is hemodynamically unstable and has no drains, they get a drain and a gastrostomy. If the patient is hemodynamically unstable with a drain, we need to add more drains and clear the area of infection. In the hemodynamically stable patient with a drain, all you need is total parenteral nutrition, antibiotics and observation,” Dr. Rosenthal said. The most common early complications after sleeve gastrectomy are bleeding and staple-line disruption, the treatment of which depends on localization. “Most leaks are in the proximal aspect of the staple line and depend on bougie size. The smaller the bougie, the higher the chance the patient will have a staple-line disruption, and 90% of those are located near the gastroesophageal junction,” Dr. Rosenthal said. While acute staple-line disruptions

‘Most leaks [after sleeve gastrectomy] trectomy] are in the proximal aspect off the staple line and depend on bougie size. ize. The smaller the bougie, the higher the chance the patient will have a staple-line disruption, and 90% of thosee are located near the gastroesophageal junction.’ unction.’ —Kimberly M. Davis, MD, MBA BA

‘CT scans read as normal in 30% of cases [of bowel obstruction]. So, you need a high index of suspicion in a patient who presents with midepigastric and periumbilical abdominal pain that is sudden in onset and may radiate to the back. The best way to manage these is with diagnostic laparoscopy for confirmation.’ —Raul Rosenthal, MD in unstable patients require re-laparoscopy and drainage, chronic patients will require proximal gastrectomy. “Stents and glues are acceptable in the first one to 12 weeks; after that, the patient will most likely need a surgical intervention.”

Late Complications: Roux-en-Y Gastric Bypass And Sleeve Gastrectomy The most common late complications after gastric bypass are cholelithiasis and choledocholithiasis, which are more frequent in bariatric patients than in the general population since the discontinuation of routine prophylactic cholecystectomy, said Kimberly M. Davis, MD, MBA, a professor of surgery at Yale School of Medicine, in New Haven, Conn. Cholelithiasis can be treated with laparoscopic cholecystectomy, but choledocholithiasis is a bit more complicated due to the altered anatomy of gastric bypass patients, and it requires collaboration with a gastroenterologist. “Patients with common duct stones after gastric bypass can be managed with either a laparoscopic common bile duct exploration, or with endoscopic retrograde cholangiopancreatography performed through the gastric remnant in the operating room,” Dr. Davis said. About 5% of gastric bypass patients experience marginal ulceration. Unperforated ulcerations can be managed with resumption of proton pump inhibitors. Perforated ulceration calls for IV antibiotics with or without percutaneous drainage. “But when a perforation requires exploration, the best management is wide drainage, oversewing of the perforation and an omental patch,” Dr. Davis said.

The most concerning complication after gastric bypass is bowel obstruction, which often stems from internal hernias that can lead to bowel ischemia and strangulation. “The internal hernia can be deadly if missed,” Dr. Fischer said. Mesenteric swirl on CT imaging is indicative of bowel obstruction, but imaging findings can be misleading, Dr. Davis said. “CT scans read as normal in 30% of cases. So, you need a high index of suspicion in a patient who presents with midepigastric and periumbilical abdominal pain that is sudden in onset and may radiate to the back. The best way to manage these is with diagnostic laparoscopy for confirmation.” Laparoscopic reduction and repair of the defect is feasible, but the anatomy can be challenging, especially for surgeons who don’t see many post-bariatric patients, Dr. Fischer said. “Starting at the terminal ileum, where the anatomy is exactly the same, and working your way backward is a nice way to get everything reduced. Though laparoscopic repair is preferable, don’t hesitate opening.” After sleeve gastrectomy, about 4% of patients will experience a stenosis, which is often a late consequence of an undiagnosed or subclinical leak that results in a dilated proximal pouch. “This can be relieved through lysis of adhesions,” Dr. Davis said. Short-segment stenosis can also be managed via balloon dilation. Longer segments may require bariatric surgery revision, “though there are increasing reports of balloon dilation and placement of 15-cm endoluminal stents, which can be removed after several months,” Dr. Davis said.

LETTER TO THE EDITOR

APRIL 2021 / GENERAL SURGERY NEWS

Late Complications: Gastric Banding

Our Mistakes ‘Walk Our Dreams’

Gastric banding is now the least popular type of bariatric surgery, but there are still an estimated 700,000 to 1.2 million bands out there, and about half of them will require surgical intervention at some point. The two main late complications are band slippage and band erosion, both of which require band removal. Band slippage occurs when a portion of the stomach slips up through the band. This is diagnosed on kidney, ureter and bladder x-ray when the band appears as an O shape rather than showing the proper angulation. “There’s a good chance we’ll need to be concerned about the vascular supply to the portion of the stomach that’s above the band,” said Christopher DuCoin, MD, MPH, an associate professor of surgery and the chief of the Division of Gastrointestinal Surgery at the University of South Florida, in Tampa. If the patient presents with symptoms that could be related to the band, start by deflating the band, using a Huber needle to remove fluid from the port. “Usually this can be done by simply palpating the port, but you might need to use fluoroscopy. The patient should experience improved symptoms shortly thereafter,” Dr. DuCoin said. To remove the band, use any device, such as an ultrasonic scalpel, to release fibrotic tissue around the band, he continued. “Once it is mobile, just cut through it. I recommend cutting the side opposite the buckle.” Having released the band, Dr. DuCoin removes it through a 15-mm trocar, documents that all of the band is out, deflates the abdomen and removes the subcutaneous port. Band erosion looks like an emergency, but it isn’t, Dr. Davis said. “Band erosion occurs over time, and any perforation is sealed by the surrounding inflammation as the perforation occurs.” Patients often complain of upper abdominal or back pain and may have melana. “But more commonly they will have an infection of the port,” Dr. Davis said. There are a couple of options for removal, Dr. DuCoin said. “You can do a completely endoscopic removal of the band, ligating it and using a snare to remove it; or you can do a laparoscopic resection.” The surgical technique Dr. Davis uses is to mobilize the left lobe of the liver, then identify and follow the path of the band to the band and buckle, which are usually located on the lesser curve of the stomach. “Once the band has been mobilized,” Dr. Davis said, “it can be cut and the entire structure removed through a ■ 15-mm port.”

To the Editor: I write to comment on the letter by Steven B. Palder, MD, in the February 2021 edition of General Surgery News [page 10]. In my opinion, Dr. Palder presents overly strong criticism of the surgical practice of Dr. Bruce Ramshaw, who described in detail “My Worst Surgical Error” in the October 2020 edition [page 25]. In this detailed account of a surgical error resulting in permanent injury to a patient, we see multiple factors converging to cause harm. These factors include personal, institutional and anatomic ones, as well as a dash of bad luck (leaving the patient intubated and unable to complain of his painful ischemic limb). In contrast to Dr. Palder’s statement, Dr. Ramshaw did take full personal responsibility for

the injury and gave us an overview of how such a disaster can occur, and how he took measures to ensure that this would not happen again in his practice. So, I am not really sure what Dr. Palder is trying to teach us. Dr. Ramshaw has already bared his soul in what is not just a mea culpa but a “mea maxima culpa.” He is living with his guilt. All surgeons make mistakes at one time or another. Dr. Mark Ravitch reminded us that our mistakes “walk our dreams.” The letter lacked compassion and understanding, and was personally critical to the point of being mean-spirited. John M. Clarke, MD St. Petersburg, Fla.

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IN THE NEWS

Court Ruling Alters Informed Consent Process continued from page 1

action if a physician delegates informed consent to another member of the patient’s care team. “Lawyers and policymakers are advising an overbroad interpretation of this decision to avoid litigation,” said Valerie Gutmann Koch, JD, the co-director of the Health Law and Policy Institute at the University of Houston, and director of law and ethics at the University of Chicago MacLean Center for Clinical Medical Ethics, during the panel session.

In 2007, Megan Shinal sought the care of Steven Toms, MD, the director of the Department of Neurosurgery at Geisinger Medical Center, in Danville, for treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. Ms. Shinal and Dr. Toms met to discuss her goals and expectations, and the risks associated with different surgical options, including total and subtotal resections. At their meeting, Ms. Shinal did not make a final decision about which surgical

approach she wanted. During a follow-up visit with Dr. Toms’ physician assistant, Ms. Shinal signed the informed consent form. It did not clearly designate which surgical procedure she preferred. During her 2008 operation, Dr. Toms performed a total resection and perforated Ms. Shinal’s carotid artery, resulting in hemorrhage, stroke, brain injury and partial blindness. Ms. Shinal and her husband sued Dr.

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‘In truth, what’s happened in reality and on the ground is individuals at every level are worried.’ —Valerie Gutmann Koch, JD Toms, alleging he failed to obtain her valid informed consent for the procedure. Ms. Shinal testified that she would have chosen a subtotal resection as a safer, less aggressive option had she known the alternatives. The jury found that Dr. Toms fulfilled his informed consent obligations. However, in June 2017, the Supreme Court of Pennsylvania overturned the decision based on the state’s MCARE Act. The act specifies that, except in emergencies, a physician owes a duty to a patient to obtain their informed consent prior to surgery. The ruling specifically interprets the Pennsylvania statute and the issue has not been litigated outside of the state. However, Pennsylvania is not the only jurisdiction mandating that the surgeon bear the responsibility of performing informed consent. A similar standard of nondelegation of informed consent might apply in other jurisdictions throughout the country, and it is unclear how such a rule affects residents and fellows in teaching hospitals, Ms. Koch said. There is limited case law on informed consent, Ms. Koch explained. The practice of medicine, including informed consent, is governed state-by-state, so the Pennsylvania decision does not necessarily apply in other jurisdictions. “In truth, what’s happened in reality and on the ground is individuals at every level are worried,” Ms. Koch said. The ramifications continue to reverberate throughout hospitals around the country. Some hospitals have changed their workflow so that as soon as a patient arrives in the emergency department, regardless of their needs, an emergency department physician obtains informed consent for a blood transfusion. This would cover informed consent in case a patient needs a transfusion overnight when residents or other advanced practice providers are managing their care, said Puneet Singh, MD, an assistant professor of surgery at The University of Texas MD Anderson Cancer Center, in Houston. “This case has dramatically changed and continues to impact care, outside

IN THE NEWS

skills, to give trainees increasing autonomy with these conversations, Dr. Redmann said. “We don't get a lot of formal training on obtaining informed consent, but it's incredibly important.” Dr. Redmann said surgeons who are considering delegating informed consent to a trainee must bear in mind three principles: Trainees do not understand the risks of procedures as well as attendings do; if a trainee does not discuss a risk that their attending might have, they are not meeting the standard of care; and the attending surgeon holds primary responsibility for the patient.

of the operating room and surgeons,” Dr. Singh said. The decision is also rippling through the world of clinical research. Ms. Koch said institutional review boards now advise clinical trial investigators to alter their consent processes to ensure that physician investigators, instead of recruitment coordinators, secure the consent of participants, she said. Ms. Koch told the virtual congress that the Shinal decision is problematic for four reasons. First, it deemphasizes process by incentivizing a narrower approach to informed consent, focusing on the person conveying the information rather than the information provided to a patient. The decision also prioritizes physician disclosure rather than patient comprehension, she said. She is concerned that the ruling reflects a judicial reaction to the evolving doctor‒patient relationship, in which multiple care providers and third parties, such as hospitals and health insurance companies, influence provision of care. Finally, the decision relied on faulty legal reasoning to conclude that a physician cannot rely on a subordinate to disclose the information required for informed consent. Reimbursement for informed consent may need to be considered if informed consent becomes the surgeon’s responsibility, Ms. Koch said. Payment for time spent obtaining informed consent would “help ensure these discussions to not get delegated to those who are insufficiently trained or not well suited to the task,” Ms. Koch said. The Shinal case should change the way informed consent is taught and obtained at academic centers, said Andrew Redmann, MD, a pediatric otolaryngologist at Children’s Minnesota, in Minneapolis. Historically, informed consent has often been delegated to trainees with minimal oversight from attending surgeons, he said. However, obtaining informed consent should be considered a learned skill, similar to operative skills, and surgical programs should adopt a system of graduated responsibility, just like for operative

“If we remember these three principles, it’s clear that many surgical training programs should critically evaluate the way that they delegate the preoperative informed consent and surgical decision-making process,” Dr. Redmann said. So, Dr. Singh recommended a communication approach known as “Best Case/Worst Case,” initially designed for older adults making difficult decisions about surgical procedures as they near the end of life (J Am Geriatr Soc 2015;63[9]:1805-1811). As she sits with a patient, she describes the best, worst and most likely case scenarios.

Dr. Singh also recommends that teams revise their workflow for informed consent in light of the Shinal decision. Patients should continue to have repeat interactions with all members of the team, making sure patients understand the risks and benefits of different options. But the surgeon should be the ultimate person who obtains informed consent and has the document signed. “This would allow us to comply with this particular case while still maintaining that rich discussion that occurs with team mem■ bers and the patient.”

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OPINION

GENERAL SURGERY NEWS / APRIL 2021

Traumatic Brain Injury continued from page 1

Acute TBIs (concussions) can be relatively mild in outcomes with transient confusion, memory loss, dizziness, and reduced attention span and concentration, but with no long-term sequelae in 80% to 90% of those affected. Immediate post-trauma diagnostic assessment is usually limited to testing cognitive function, coordination of movement and ocular alterations; there are no available diagnostic or prognostic indices, including brain CT. On the athletic field, saliva testing for microRNAs is under assessment in several sport venues. Therapy for acute TBIs consists of the recommendation for physical and mental rest. Of individuals with a severe single TBI or multiple acute TBIs, 10% to 20% will exhibit chronic TBI. Beyond the primary mechanical insult to the brain, prolonged metabolic damage can affect neurons, cerebral blood vessels and glia, which, in turn, may initiate chronic inflammation causing prolongation of neurogenic symptoms, as well as cardiovascular, gastrointestinal and sexual dysfunction. The CDC groups the symptomatology of TBI sequelae into four domains: Domain I: Thinking/remembering deficiency, ranging from mild to severe, eventually progressing to dementia. Domain II: Physical symptoms of migraine headaches, blurred vision, dizziness, nausea, light and noise sensitivity, fatigue, and balance problems. Headaches are the most characteristic physical impairment of TBI, markedly diminishing quality of life. Domain III: Mood and emotional symptoms of progressive depression and post-traumatic stress disorder, the latter most frequent in individuals subjected to violent trauma. The end stage of this impairment is suicidal ideation and progression to suicide. Domain IV: Sleep disturbances, often in association with obstructive sleep apnea, especially in the obese. There is no blood, x-ray or other signature marker for the presence, progression or resolution of chronic TBI. There is no prophylactic therapy to prevent acute TBI from progressing to chronic TBI, and chronic TBI to chronic traumatic encephalopathy (CTE). The unfortunate end result of worsening TBI is CTE, today an incurable progressive form of neurodegenerative disease culminating in dementia and early death. Subjective symptomatology provides diagnosis during life; definitive diagnosis of CTE is made only on autopsy by the presence of characteristic tau proteins in the sulci of a shrunken brain. There are two staggering public autopsy series in football players demonstrating tauopathy in 99% (110/111) of professional, and 91% (48/53) of college, football players. The time course of severe TBI to CTE to death can be relatively brief: two to three years. However, the time from the initial traumatic event or events to end-stage TBI is relatively long: 10 years or more. This offers a window of opportunity for deleterious risk factors to accelerate the process, as well as for therapeutic intervention to retard or halt progression. Three studied risk factors for progression of TBI are inflammation, cardiovascular disease or risk factors, and obesity. Of note, they are reciprocally causative. TBI leads to inflammation, and inflammation, even from unrelated causes (e.g., rheumatoid arthritis), accelerates TBI

progression. Cardiovascular disease and cardiovascular disease risk factors are known to promote TBI symptoms, and TBI reciprocally accentuates cardiovascular impairment. Patients with TBI tend to become obese, and obese persons sustaining acute brain injury are more likely than lean individuals to exhibit TBI progression. In a cohort of great public interest, former NFL football players, studies have demonstrated statistically significant correlations of obesity, cardiovascular disease and TBI. In light of this knowledge, patients with TBI should be counseled on avoiding cardiovascular disease risk factors and weight gain. Inclusion of TBI among the multitude of obesity comorbidities or secondary diseases has not been well appreciated, although there is excellent evidence in the literature that obesity, particularly morbid obesity, impairs multiple functional parameters: global cognition, attention span, executive function and memory, and promotion and progression of depression. These functional parameters are associated with adverse structural brain changes: hypoperfusion, atrophy, dysfunction of microglia and astro-

cytes, neuronal injury and death, cerebral vascular insufficiency, formation of neurofibrillary tangles, and increased tau expression. There is also reputable literature evidence demonstrating mitigation or reversal of these functional and anatomic changes by significant and sustained weight loss. Today, the most effective and lasting therapy for morbid obesity, or severe obesity with life-threatening comorbidities, is, of course, metabolic/bariatric surgery. There is also a growing literature substantiating mitigation, arrest or even reversal of TBI symptomatology by metabolic/bariatric surgery. Among the 35 affirmative peer-reviewed publications, three noteworthy papers bear on cognitive dysfunction, the cardinal TBI impairment. Alosco et al (Am J Surg 2014;207[6]:870876) showed improvement in cognitive function up to three years after metabolic/bariatric surgery, in contrast to the rapid deterioration of cognition usually found in patients with progressive TBI. Thiara et al (Psychosomatics 2017;58[3]:217-227) in a systematic review documented improvement in a neurocognitive domain in 10 of 10 studies. And Marques et al (J Clin Endocrinol Metab 2014;99[11]:E2347-E2352), at 24 weeks after metabolic/bariatric surgery, linked improvement in executive function with increased cerebral metabolism and decreased inflammatory parameters. A full review, in three parts, of metabolic surgery, obesity and TBI has been published by McGlennon et al (Obes

Surg 2020;30[12]:4704-4714; 2021;31:4802-4814; 2021;31:4920-4907. Two questions raised by the mitigating effects of metabolic/bariatric surgery on symptoms common to TBI in a cohort of obese individuals are: First, can these benefits be extended to the nonobese patient with TBI? Second, can elucidation of the metabolic mechanisms responsible for the outcomes of metabolic/bariatric surgery provide insight into the causative and enabling metabolic processes culpable for TBI? With resolution of type 2 diabetes by metabolic/bariatric surgery firmly documented and accepted by the global medical community, a search for a non-, or minimal, weight loss/metabolic operation was initiated worldwide. Modifications of bariatric surgery and bariatric surgery unrelated, extraperitoneal operations to treat type 2 diabetes, were suggested and tested. Today these investigations are in their infancy but are being vigorously pursued. It is reasonable to predict that a similar initiative to treat TBI by modified metabolic/bariatric surgery, or by totally new metabolic surgery interventions in the nonobese, will be proposed once it is definitively demonstrated by Level I evidence (i.e., a randomized controlled trial) that metabolic surgery is effective therapy for TBI in the obese. Slowly but progressively, the metabolic processes responsible for the effects of metabolic/bariatric surgery in obesity are being elucidated, and, thereby, are providing not only insights into the underlying mechanisms of surgical therapy but for the disease of obesity itself. These insights may also help us to understand the metabolic mechanisms responsible for TBI and the way in which metabolic surgery may ameliorate TBI. The basis for this perspective is the well-established, literature-documented evidence for a highly active gut– brain axis. Certain areas of the brain, in white and in gray matter, show alterations in both obesity and TBI. These areas demonstrate improvement in structural integrity and functional connectivity after metabolic/bariatric surgery, with corresponding clinical improvement in neurocognitive functioning. The metabolic processes independent of weight responsible for the resolution of type 2 diabetes, hypertension and dyslipidemia after metabolic/bariatric surgery may also affirmatively affect the anatomic and clinical aspects of TBI. The underlying mechanisms of the gut–brain axis involving the rich parasympathetic (e.g., vagal), sympathetic (e.g., celiac axis) and submucosal neural syncytium, as well as the gut-elaborated hormones, are dramatically altered by metabolic/bariatric surgery–induced changes in gut structure, the microbiome and bile acid composition. Once we fully understand these perturbations, we may come to recognize why TBI affects the gut, and, more importantly, why the gut affects the genesis of TBI and can play a major role in treating TBI. Nearly all human afflictions are metabolic in origin or severity. In the realm of therapeutics, the role of metabolic surgery has become a reality. We have established metabolic surgery for hyperlipidemia, obesity, type 2 diabetes, metastatic cancer, hypertension and depression, as well as other less frequent diseases. To this list, ■ we may soon be able to add TBI. —Dr. Buchwald is a professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery (emeritus), at the University of Minnesota, in Minneapolis. His articles appear every other month.

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GENERAL SURGEON BETH ISRAEL DEACONESS PLYMOUTH The Division of General Surgery at Beth Israel Deaconess Medical Center (BIDMC)/ Beth Israel Lahey Health (BILH) is seeking a general surgeon who will be primarily based at our Beth Israel Deaconess Hospital-Plymouth location in Plymouth, Massachusetts. The surgeon will also hold clinical privileges at Beth Israel Deaconess Medical Center in Boston. Applicants must be board-certified/board-eligible in general surgery. Candidates with fellowship training or special qualifications in advanced laparoscopy are preferred. The successful candidate for this position may be considered for Harvard Medical School appointment at the rank of Instructor, Assistant Professor or Associate Professor, commensurate with experience, training and achievement in the field. BIDH-Plymouth is an acute care, 150-bed community hospital serving 12 towns in Plymouth and Barnstable counties and is the largest hospital in the southern region of the South Shore. Beth Israel Deaconess Medical Center is a part of is part of Beth Israel Lahey Health, a new health care system of academic medical centers and teaching hospitals, community and specialty hospitals with more than 4,000 physicians and 35,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions or any other characteristic protected by law. Women and underrepresented minorities are particularly encouraged to apply. Applications are made online at www.hmfphysicians.org/careers. Please respond to requisition: 201496

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Intraabdominal Infections continued from page 1

[Larchmt] 2010;11[1]:79-109; Surg Infect [Larchmt] 2014;15[4]:417-424). “This topic is tricky,” said Jin Ra, MD, FACS, an associate professor of surgery and the vice chair of quality and safety in the Division of Acute Care Surgery at the University of North Carolina at Chapel Hill. “The evidence leans towards shorter duration in patients with adequate source control, but no studies say ‘yes, this is definitely what we need to do.’ And often an individual surgeon’s preference will outweigh the guidance.” Late last year, Dr. Ra and fellow committee members from the Eastern Association for the Surgery of Trauma dug into the existing research to see whether they could bring greater clarity to the evidence. After conducting an extensive literature search, the committee focused on 16 studies—randomized controlled, prospective or retrospective analyses—that compared long and short duration of antimicrobial treatment and examined a handful of outcomes: mortality, surgical site infections, persistent/recurrent abscesses, readmissions, unplanned operative intervention and length of stay. Across each outcome, the research revealed a small but not statistically significant benefit for patients receiving a shorter course of antibiotics (an average

of four days) compared with a longer course (an average of eight days). When considering the outcomes as a whole, the committee provided a conditional recommendation for shorter over longer antibiotic duration.

‘The bottom line is not that four days is better, but that the difference between four and eight days looks to be negligible when it comes to outcomes such as mortality, SSIs and length of stay.’ —Nicole A. Stassen, MD “These recommendations align with the literature and previous guidelines on the preferred minimum course of antibiotics for this patient population,” said Nicole A. Stassen, MD, the director of the Kessler Family Burn/Trauma Intensive Care Unit and a professor of surgery at the University of Rochester, in New York, who was not involved in the EAST guidelines. Nevertheless, Drs. Ra and Stassen acknowledged the limits of the data to date. “Summarizing and reaching definitive conclusions with this mixed bag of study quality and consistency presented a challenge,” Dr. Ra said.

Outcome results were not uniform across the 16 studies included (https:// bit.ly/3t4BUGk). Of the 10 analyses that examined mortality, for instance, six favored the shorter duration group and four favored the longer duration group. Of the 13 studies that looked at recurrent or persistent abscesses, six favored a shorter course and seven favored a longer course, but overall the evidence revealed a slight preference for shorter duration. Even within a single analysis, the results can paint a complex picture. In the randomized controlled STOP-IT trial, which Dr. Ra considers one of the more rigorous studies, grouping SSIs, recurrent intraabdominal infections and death together showed a slight benefit for shorter duration: 21.8% (56/257 patients) versus 22.3% (58/260 patients) (N Engl J Med 2015;372[21]:1996-2005). When examining each category individually, the data captured a more nuanced picture. For mortality, longer duration edged out shorter direction slightly (0.8% vs. 1.2%, a difference of one patient). For recurrent intraabdominal infections, longer duration also appeared slightly preferable (13.8% vs. 15.6%). But for SSIs, short duration showed a more pronounced benefit (8.8% vs. 6.6%). Taking the heterogeneity of the evidence into account, “shorter antibiotic duration was, at least, comparable to longer duration and certainly didn’t lead to worse outcomes overall,” Dr. Ra added.

Although the available evidence does not strongly point in one direction yet, Drs. Ra and Stassen highlighted a range of benefits associated with reducing a patient’s course of antibiotic treatment. “The bottom line is not that four days is better, but that the difference between four and eight days looks to be negligible when it comes to outcomes such as mortality, SSIs and length of stay,” Dr. Stassen said. “So given the risk of complications associated with antibiotic use, why extend the course to eight days?” A shorter course of antibiotics means “lower costs and hospital resources, shorter length of stay and reduced risk of introducing multidrug-resistant organisms,” Dr. Ra added. “We’ll likely also see greater patient satisfaction because patients will avoid potential side effects from longer courses.” Despite the case for minimizing a patient’s time on antibiotics, in certain scenarios, patients may benefit from a longer treatment course. “In some cases, a physician may extend the course of antibiotics because the patient doesn’t seem to be responding well enough in a shorter time frame,” Dr. Stassen said. Dr. Ra agreed that physicians still need to use their clinical judgment to evaluate patients on a case-by-case basis. “If your patient is still having fevers or there are clinical signs of ongoing infection, they may benefit from a longer course of anti■ biotics,” she said.

The Scientific Greats: A Series of Drawings By MOISES MENENDEZ, MD, FACS

Ignaz Philipp Semmelweis (1818-1865)

ountries around the world are struggling to control the COVID-19 pandemic, with more than 107 million confirmed cases and more than 2.4 million confirmed deaths as of early March. One of the most prominent pieces of advice being given to help control the spread is quite simple: Wash your hands. However, in the 19th century, the doctor who pioneered handwashing was ridiculed for his claim that it reduced the spread of infections. Ignaz Semmelweis was a Hungarian physician and scientist who lived between 1818 and 1865. Semmelweis, now known as an early pioneer of antiseptic procedures, is also described as the “savior of mothers.” Semmelweis discovered that the incidence of puerperal fever (also known as “childbed fever”) could be drastically cut by the use of hand disinfection in obstetrical clinics. Puerperal fever was common in mid‒19th-century hospitals and often fatal. Semmelweis proposed the practice of washing hands with chlorinated lime solutions in 1847, while working in Vienna General Hospital’s First Obstetrical Clinic, where doctors’ wards had three times the mortality of midwives’ wards. Despite various publications of results that showed handwashing reduced mortality to less than 1%, Semmelweis’ observations conflicted with the established scientific and medical opinions of the time, and

his ideas were rejected by the medical community. He could not offer an acceptable scientific explanation for his findings, and some doctors were offended by the suggestion that they should wash their hands and mocked him for it. In 1865, the increasingly outspoken Semmelweis supposedly suffered a nervous breakdown and was committed to an asylum by his colleagues. He died 14 days later after being beaten by the guards. He developed an infected wound on his right hand which might have been caused by the beating. Semmelweis’ advocated practice earned widespread acceptance only years after his death, when Louis Pasteur confirmed the germ theory, and Joseph Lister, acting on the French microbiologist’s research, practiced and operated using hygienic methods, with great success. ■ Sources Carter KC, Abbott S, Siebach JL. Five documents relating to the final illness and death of Ignaz Semmelweis. Bull Hist Med. 1995;69(2):255-270. Ignaz Semmelveis. pt.LinkFang.org. Van de Laar, A. Under the Knife: A History of Surgery in 28 Remarkable Operations. St. Martin’s Press; 2018:1-106. Ignaz Philipp Semmelweis (1818-1865)

—Dr. Menendez is a general surgeon and self-taught portrait artist in Magnolia, Ark. Since 2012, he has completed a series of portraits of historical figures, in particular well-known physicians and surgeons.

Work done with charcoal and carbon pencils on 140 lb watercolor paper, 12 x 16 2017 Artist: Moises Menendez, MD, FACS

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