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Device Uses Mechanotransduction To Treat Small Bowel Syndrome
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gives a subjective impression of related growth in the number of articles on the value of these skills for the training and practice of surgery. More than 20 years ago, surgeons agreed that mental skills are a large component of performance excellence.4 More recently, this perspective has been reinforced in the surgical literature for performance and procedural preparation.5,6
Mental imagery may be the most frequently cited technique, but critical skills such as emotion regulation, negative thought stopping, affirmations, self-talk, breathing techniques and others are also described, as are individual, group and comprehensive curricular approaches.7,8
A perceived increasing emphasis on training mindset and mental skills suggests an important trend, but this is subjective. In an attempt to objectively document the growing surgical focus on the value of training and use of mental skills through the frequency of relevant publications, we surveyed the surgical literature from 1990 to May 2021 for articles published on this topic.
A search of the literature was conducted in the databases PubMed, Web of Science and Google Scholar. Two thousand articles were retrieved and assessed for specific relevance. Articles on non-surgeon populations were discarded. Furthermore, articles on general aspects of resilience and wellness in surgeons (although important and impacting performance) were also excluded to focus on psychological skills and concepts directly related to enhancing surgical performance.
Our findings are shown in the Figure, which displays the number of publications on mental skills in surgery on a five-year basis from 1990 to 2019.
As can be seen in this figure, there has been steadily increasing growth, with a positively accelerating trend in the past decade, of publications related to mental skills for training and performance in surgery.
Our analysis is limited to articles that focused on psychological performance concepts and skills such as mental training, mental practice, mental skills and mental toughness. This approach was adopted to avoid potential contamination
80
70
Number of Articles
60
50
40
30
20
33 50
10
0
1 2 3 7
1990-1994 1995-1999 2000-2004 2005-2009 2010-2014 2015-2019
5-Year Period
Figure. Number of publications on mental performance skills in surgery.
by other similar terms in the surgical literature like “cognitive training” and “nontechnical skills,” which often do refer to psychological skills, although not necessarily or exclusively. However, if articles on these terms are included, the same pattern emerges, just with higher absolute numbers.
A systematic review of the impact of mental practice on surgical performance described benefits from the use of this technique.9 Of note, despite using a different search strategy and focus resulting in higher absolute numbers, an incidental finding of a similar pattern of increasing frequency of publications in this area was reported.
Novel Device Uses Mechanotransduction To Treat Small Bowel Syndrome
By MONICA J. SMITH
Applying the concept of mechanotransduction to the small intestine in animal models, researchers have had success in regenerating tissue. They expect to soon begin human trials to treat patients with short bowel syndrome, a rare but debilitating disease with few, usually less than satisfactory, treatment options.
“The basic concept is similar to distraction osteogenesis, which orthopedic surgeons have used for years, applying distraction force to broken bone that will grow up to a millimeter a day,” said Andre Bessette, the CEO and a co-founder of Eclipse Regenesis, Inc., a medical device company in Menlo Park, Calif.
How It Works
How It Started
Seeing colleagues in orthopedic medicine successfully stimulate bone growth, James Dunn, MD, PhD, wondered if that concept could be applied to the unmet need he saw in his pediatric patients with short bowel syndrome (SBS).
“He literally started off with a screw-and-nut concept in a rat model and slowly put some distraction on this intestinal tissue and—lo and behold—it grew new intestinal tissue,” Mr. Bessette said.
From that point, around 2005, Dr. Dunn devoted himself to documenting his research and proving the science behind it—“the basic science at the cellular level, the stimulation of growth factors, what type of tissue is created: Is it scar tissue? Is it functional? Will it disappear? What he found was that this procedure produces healthy, viable small intestine tissue,” Mr. Bessette said. To regenerate small-bowel tissue, a surgeon inserts the device, which looks like a small, compressed coil, inside the small intestine and secures both ends with plication sutures applied to the outside of the intestine. Over two to three weeks, the device slowly expands to its uncompressed state, stimulating new tissue growth—ultimately two to three times the segment’s original length, about 4 cm.
Once this process is complete, the chromic sutures dissolve over about a month, allowing the device to pass through the body to be excreted.
Preclinical studies have shown successful lengthening (tissue growth), no perforations and no obstructions, and the newly formed tissue looks and acts like normal intestinal tissue with regard to metabolic uptake
and contractile function. (These studies are available on Eclipse’s website at www.eclipseregenesis.com/ publications.) “Patients with SBS have lost more than 50% of their small intestine, so they’ll need more than one device applied or more than one procedure,” Mr. Bessette said. Treatment will vary depending on a patient’s starting point (how much small intestine they have), and their end point (how much new intestine they need) to achieve the clinical benefits of reducing total parenteral nutrition dependence and being able to absorb nutrients from the food they eat. Michael R. Harrison, MD, the director emeritus of the Fetal Treatment Center at the University of California, San Francisco, is not involved in Dr. Dunn’s research, but has been following the company’s progress for the past decade. “I like the people, and I really like the technology— the idea of mechanotransduction, that you can push on something a little bit over a long period of time and This 20-mm diameter device is change biology. We’ve been using this principle for a intended for older and larger pediatric long time,” Dr. Harrison said.
patients; younger patients would receive a 10-mm diameter device. Eclipse: On the Horizon
One of the newest companies to join the acclaimed Fogarty Innovation Accelerator Program, Eclipse Regenesis recently was awarded a National Institutes of Health Small Business Innovation Fast Track grant of $1.7 million to help promote research on the Eclipse XL1 System.
“The Fast Track grant will allow us to fund the final animal studies we need to do for our FDA submission,
Our results suggest there is indeed a growing interest in the value of mental skills for surgical trainees and practitioners. These skills are not a verbal, passive, reflective, existential experience, but active outcome- and performancefocused, empirically driven skills. Applications include both general and specific psychological skills and general and specific surgical techniques.7,10 Given the innovative integration of mental skills training in other disciplines and the encouraging impact of mental skills and such training on surgical performance (and careers), this increasing interest and emphasis is welcome and should be disseminated and encouraged in surgical education and training.9,11 ■
References
1. Asken M, Kochert E, Wyatt A, et al.
Calm amidst storm: psychological skills and mindset training for maximizing performance in medical emergencies.
Resuscitation. 2020;146:32-33. 2. Asken M. Code calm: mental toughness skills for medical emergencies. 2021.
Amazon Kindle.
3. Deshauer S, McQueen S, Mobilio M, et al.
Mental skills in surgery: lessons learned from virtuosos, Olympians and Navy
which will lead to phase 2 funding for the first in-human clinical trials,” Mr. Bessette said.
He and his colleagues expect to start these trials in the first half of 2022, and they have identified two primary investigator sites: Boston Children’s Hospital and Cincinnati Children’s Hospital. Although they intend to eventually extend the procedure to adults, they plan to start with pediatric patients.
“That’s where we see the greatest need and also the greatest benefit. The longer you’re on TPN [total parenteral nutrition], the greater the risk of sepsis from a central-line infection and the higher the risk for liver failure. Getting these young patients off TPN sooner in life will only benefit them,” Mr. Bessette noted.
“We’re excited to be getting close to performing the first-in-human procedure, and we hope to eventually be able to perform this procedure completely endoscopically,” he said. ■
Column Editor:
Michael A. Goldfarb, MD, clinical professor of surgery, Rutgers University Medical School, in New Brunswick, NJ.
Seals. Ann Surg. 2021;274(1):195-198. 4. McDonald J, Orlick T, Letts M. Excellence in surgery: psychological considerations. Contemporary Thought in
Performance Enhancement. 1994;3:13-32. 5. Asken M, Yang H, Aboushi R, et al.
Prepping for surgery: surgeon prepare thyself. Am J Surg. 2020;221(4):775-776. 6. Rosenthal R, Rosales A, Menzo E, et al.
Mental Conditioning to Perform Common
Operations in General Surgery Training.
Springer; 2020. 7. Anton N, Bean EA, Hammonds SC, et al. Application of mental skills training in surgery: a review of its effectiveness and proposed next steps. J Laparoendosc
Adv Surg Tech A. 2017;27(5):459-469. 8. Asken M, Yang H. SIM: The surgeon’s imagery mindset, performance enhancing mental imagery and the optimization of surgical skill. 2021. Amazon
Kindle.
9. Snelgrove H, Gabbott B. Critical analysis of evidence about the impacts on surgical teams of “mental practice” in systematic reviews: a systematic rapid evidence assessment. BMC Med Educ. 2020;20:221. 10. Arora S, Aggarwal R, Sevdalis N, et al.
Development and validation of mental practice as a training strategy for
laparoscopic surgery. SurgEndosc. 2010;24(1):179-187. 11. Anton N, Lebares C, Karapidis T, et al. Mastering stress: mental skills and emotional regulation for surgical performance and life. J Surg Res. 2021;263:A1-A12.
—Dr. Asken is the director at Provider Well-Being, UPMC in Central Pa., Harrisburg, Pa. Ms. Morgan is a medical librarian, UPMC in Central Pa., Harrisburg, Pa. Dr. Owens is the chair of the Department of Surgery, UPMC in Central Pa., Harrisburg, Pa.
Welcome to the December issue of The Surgeons’ Lounge. In this issue, Armando Rosales, MD, a staff surgeon specializing in minimally invasive foregut and hepatobiliary surgery at AdventHealth, in Orlando, Fla., discusses gastrointestinal stromal tumors associated with neurofibromatosis type 1 syndrome. This issue also looks at the history of the STOP the Bleed campaign.
We look forward to our readers’ questions, comments and interesting cases to present. Sincerely,
Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org ACS nge
Figure 1. Preoperative evaluation with abdominopelvic CT of the pancreas revealed a 2.4-cm ovoid arterially enhancing mass in the proximal third portion of the duodenum with mild to moderate wall thickening.
Figure 2. Pancreaticoduodenectomy demonstrated a 2.5- by 2.5- by 2.5-cm solid mass in the duodenum, which grossly appeared to consist of two adjacent tumors.
QUESTION for Armando Rosales, MD
From Elliot Toy, MD, PGY-1, Advent Health Orlando, and Lisandro Montorfano, MD, PGY-4, Cleveland Clinic Florida, in Weston
We present the case of a 75-year-old woman with no known history of malignancy who presented with upper abdominal pain and iron deficiency anemia. CT of the abdomen was suggestive of duodenal wall thickening. The patient subsequently underwent an upper endoscopy of the gastrointestinal tract and endoscopic ultrasound that revealed a duodenal ulcer and an underlying 16- by 9-mm hypoechoic oval mass with well-defined borders that involved all the wall layers of the second portion of the duodenum.
Fine needle aspiration (FNA) and an on-site rapid evaluation of the duodenal mass revealed a welldifferentiated neuroendocrine tumor (NET). The permanent cell block revealed nests and clusters of relatively uniform epithelial cells with salt-and-pepper nuclei, eosinophilic cytoplasm, and absence of cytologic atypia. The epithelial cells were positive for synaptophysin, which supported the diagnosis of a well-differentiated NET. Unexpectedly, the cell block also revealed rare fragments of spindle cells set in a collagenous background, which displayed immunopositivity for CD117 and DOG-1, thus supporting the diagnosis of a gastrointestinal stromal tumor (GIST). Because of the unusual cytologic findings in the FNA, the prospect of two separate tumors—NET and GIST—was raised. The patient was subsequently referred to our pancreaticobiliary surgeons for resection of the duodenal mass. Upon further clinical workup, it was found that the patient had a history of neurofibromatosis type 1 (NF1) syndrome.
Clinical examination revealed several cutaneous neurofibromas. Preoperative evaluation with abdominopelvic CT of the pancreas revealed a 2.4-cm ovoid arterially enhancing mass in the proximal third portion of the duodenum with mild to moderate wall thickening (Figure 1). In addition, a 0.7-cm arterially enhancing ovoid lesion was noted. The patient subsequently underwent a pancreaticoduodenectomy, which demonstrated a 2.5- by 2.5- by 2.5-cm solid mass in the duodenum that grossly appeared to consist of two adjacent tumors (Figure 2).
Histologic examination showed two separate neoplasms in close proximity. The superficial tumor infiltrated the duodenal wall and was positive for cytokeratin AE1/AE3 and somatostatin, supporting the diagnosis of a somatostatin-producing, well-differentiated NET. The deeper located tumor was a spindle cell neoplasm that was positive for DOG-1 and CD117, consistent with a GIST. The combination of such cytologic findings has almost exclusively occurred in patients with NF1 syndrome. Hence, the coexistence of a duodenal/periampullary NET and GIST is deemed virtually pathognomonic for NF1 syndrome.
In summary, the current case documents concomitant well-differentiated NET cells and GIST diagnosed in the same FNA from a composite tumor of the periampullary duodenum.
• We know NF1, also known as von Recklinghausen’s disease, is an uncommon genetic disorder associated with the development of benign and malignant tumors. What combination of gastrointestinal tumors is most commonly found in patients with NF1 syndrome? • What age groups are affected by NF1 syndrome? • Why do you think this is relevant for your clinical practice?
Dr. Rosales’ RESPONSE
In response to your first question, the most common tumors associated with NF1 syndrome are GISTs, followed by NETs and then pheochromocytomas. Regarding your second question, the age groups predominantly affected by NF1 are children or adolescents. However, it has been seen in the elderly, as described in this case presentation.
To address your last question, the management of patients with NF1 syndrome is based on careful surveillance. When a tumor is found, a multidisciplinary approach is needed. In the case of localized, resectable GISTs, surgical treatment is the mainstay and laparoscopic surgery is a valid option. The rare coexistence of the simultaneous finding of NETs and GISTs in the same FNA should alert the clinician for the possibility of NF1 syndrome, and appropriate workup should be obtained.
Suggested Reading
• IJzerman NS, Drabbe C, den Hollander D, et al. Gastrointestinal stromal tumours (GIST) in young adult (18-40 years) patients: a report from the Dutch GIST Registry. Cancers (Basel). 2020;12(3):730. • Joo M, Lee HK, Kim H, et al. Multiple small intestinal stromal tumors associated with neurofibromatosis-1. Yonsei Med J. 2004;45(3):564-567. • Kramer K, Hasel C, Aschoff AJ, et al. Multiple gastrointestinal stromal tumors and bilateral pheochromocytoma in neurofibromatosis. World J Gastroenterol. 2007;13(24):3384-3387. • Makita N, Kayahara M, Kano S, et al. A case of duodenal neuroendocrine tumor accompanied by gastrointestinal stromal tumors in type 1 neurofibromatosis complicated by life-threatening vascular lesions. Am J Case Rep. 2021;22:e927562. • Park EK, Kim HJ, Lee YH, et al. Synchronous gastrointestinal stromal tumor and ampullary neuroendocrine tumor in association with neurofibromatosis type 1: a report of three cases.
Korean J Gastroenterol. 2019;74(4):227-231.
STOP the Bleed Campaign
By Narinderjeet Kaur, medical student, Ross University School of Medicine, Miramar, Fla., and Lisandro Montorfano, MD, PGY-4, Cleveland Clinic Florida
According to the World Health Organization, more than 5 million deaths are caused by traumatic injuries worldwide each year.1 Post-traumatic bleeding resulting in coagulopathy has been the leading cause of preventable death upon presentation to the emergency department. A report published in 2017 found that up to 20% of preventable deaths were related to trauma.2 The report noted the significant improvements in prehospital trauma care leading to preventable deaths in combat made by the U.S. military, and stressed the essentials of effective response from bystanders being an important link in improving trauma system care.2 It has been shown that 30% to 40% of trauma mortality is caused by hemorrhage, and, of these, 33% to 56% occurs during the prehospitalization period with the underlying cause of early mortality being coagulopathy, continued hemorrhage and incomplete resuscitation.3,4
On April 19, 2015, following the fatal mass shooting event at Sandy Hook Elementary School, in Newtown, Conn., the American College of Surgeons convoked the Joint Committee to Create a National Policy to Enhance Survivability from Intentional Mass-Casualty and Active Shooter Events, with collaboration from the medical community, federal government representatives, the National Security Council, the U.S. military, the FBI, and governmental and nongovernmental emergency medical response organizations, among others.
The committee was led by trauma surgeon Lenworth M. Jacobs, MD, MPH, FACS, FWACS, a professor of surgery and traumatology and emergency medicine at the University of Connecticut School of Medicine, in Farmington. The committee reported their recommendations in the “Hartford Consensus,” which consists of four reports. The principle of the Hartford Consensus is that, “in case of intentional mass casualty and active shooter events, no one should die from uncontrollable bleeding.”5 The Hartford Consensus III: Implementation of Bleeding Control was presented at the White House roundtable forum in April 2015. Subsequently, in October 2015, former President Barack Obama launched the STOP the Bleed campaign as part of the National Preparedness System.6
In 2013, a group of military medical providers collaborated on a Facebook page called Next Generation Combat Medic (NGCM), with the aim of sharing Free Open Access Meducation (FOAMed) resources with military and prehospital medics. The Tourniquet Project (TTP) had similar objectives of sharing medical education regarding basic hemorrhage control techniques to save lives. While NGCM had a large military group following, the TTP following was civilian-based.2
While the administrators of NGCM and TTP contemplated on how to best fill the gaps of the STOP the Bleed campaign’s goal of training 200 million Americans, another mass shooting took place in Las Vegas on Oct. 1, 2017. Within 12 hours of the Last Vegas shooting, the STOP the Bleed campaign was launched. The campaign leveraged social media to establish a network of regional coordinators who would work together to raise public awareness and be directed to nearby bleeding control courses. An arbitrary date of March 31, 2018, was chosen as the National STOP the Bleed Day (NSTBD), which was later expanded to two weeks (March 26 to April 7, 2018) due to potential conflicts of national sporting events and religious holidays. The lessons learned in FOAMed, initiated by TTP, NGCM and special operations National Medical Association’s Scientific Assembly,
continued on page 12
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The Fifth Annual Symposium for Research in Surgical Palliative Care
By MELISSA RED HOFFMAN, MD
This year’s symposium coincided with the 20th anniversary of the first meeting of the Surgical Palliative Care Task Force (the precursor to the Committee on Surgical Palliative Care), which first convened in Chicago, on Sept. 10, 2001. Since the initial meeting, the field of surgical palliative care, defined by Geoffrey P. Dunn, MD, FACS, as “the attention to suffering in all of its manifestations of the patient and the family under surgical care,” has continued to develop and mature.
According to the American Board of Surgery, there are currently 75 surgeons board certified in hospice and palliative medicine, with several more enrolled in a oneyear fellowship, and several enrolled in the fellowship application process. There are also many surgeons who routinely integrate palliative medicine principles into their surgical practice.
The following are the presentations from the meeting: 1. Joseph A. Lin, MD, presented his abstract titled
“Development of a Primary Palliative Care Vertical
Curriculum for Surgery Residents.” The curriculum spans all five years of residency and is modeled after surgical training, with graduated complexity that includes learning both basic and advanced palliative care skills and then eventually learning how to teach these skills to junior residents.
2. Halle Ellison, MD, FACS, discussed her abstract,
“Undergraduate and Graduate Medical Learners’
Reflections on a Palliative Care Rotation” and reflected upon five themes—empathy, humanism, challenge, meaning and transformation—that emerged through written narratives provided by the learners. Dr. Ellison concluded that “a palliative care rotation helped learners to become better communicators and more fully connect with patients and their families” and postulated that the rotation “may help to counter the decline in empathy that often occurs during medical education.”
3. Erin A. Strong, MD, MBA, MPH, presented
“Palliative Care Specialty Consultation in Patients with Peritoneal Carcinomatosis undergoing CRS/
HIPEC with Palliative Intent.” The purpose of the study was to evaluate the incidence and timing of palliative care consultation in patients undergoing palliative cytoreductive surgery and/ or hyperthermic intraperitoneal chemotherapy, and concluded that “the ideal timing for palliative care consultation at a tertiary cancer center would be at the time of referral or immediately after the first specialty oncology visit.” Dr. Strong also suggested that “high-risk anesthesia consults could serve as a trigger event if a palliative care consultation has not already occurred.”
4. Caitlin Hodge, MD, MPH, presented “Association
Between Cancer Diagnosis and End of Life
Wishes,” a pilot project using the Five Wishes document and patient interviews to compare end-of-life wishes between patients with cancer receiving treatment for cure, patients with metastatic disease undergoing treatment and patients who are no longer receiving treatment.
5. Lastly, Hiren V. Patel, MD, PhD, discussed “Factors
Associated with Palliative Intervention Utilization in Metastatic Renal Cell Carcinoma.”
The symposium concluded with a brief tribute to Robert A. Milch, MD, FACS, who died this year on June 4. Dr. Milch was a general and vascular surgeon who co-founded Hospice Buffalo in 1978, and eventually became the hospice medical director. Along with Dr. Dunn, he was the co-chair of the Surgical Palliative Care Task Force and worked closely with Dr. Olga Jonassen to promote the principles of palliative medicine throughout the College. He also served as a consultant for multiple countries, including Hungary, Slovenia and Croatia, as they started their national hospice programs.
The symposium, which was sponsored by the American College of Surgeons’ Committee on Surgical Palliative Care, was held virtually on Nov. 4, 2021. Anne Mosenthal, MD, FACS, the chair of the committee, kicked off the event, which was organized by Ana Berlin, MD, MPH, FACS, Susan D. McCammon, MD, FACS, and Vanessa P. Ho, MD, FACS. ■
Issues in Surgical Palliative Care
For more information about the field of surgical palliative care, follow @surgpallcare on Twitter and consider joining the recently launched Surgical Palliative Care Society (www.spcsociety.org).
—Dr. Hoffman is an acute care surgeon and hospice attending in Asheville, N.C., and the host of The Surgical Palliative Care Podcast. To learn more about her, visit her website at www.redhoffmanmd.com. She is a member of the editorial advisory board of General Surgery News.
STOP the Bleed
continued from page 11
were applied in NSTBD to optimize viewership and interaction across social media platforms using the hashtag #NSTBD18 to empower people to become a part of NSTBD to making a difference. NSTBD included 43 states and 18 countries, with a total of 1,884 registered courses at bleedingcontrol.org with training of 34,699 students during the two-week period.2
The goal of the STOP the Bleed campaign emerged as a public health initiative to raise awareness and educate lay civilians to act as immediate responders to help victims of traumatic events by stopping or slowing life-threatening hemorrhages until primary responders, such as emergency medical services (EMS) or other medical professional help, arrive. EMS is not allowed to enter and provide medical assistance until the identified threats have been mitigated by specially trained police due to historically being victims of secondary threats of explosive devices and additional shooters. The window of opportunity to save a life from a major arterial bleed is less than five minutes, making bystanders’ training essential to saving lives due to mass casualties from active shooters.
STOP the Bleed classes are composed of a one-hour didactic lecture and two skill training stations consisting of tourniquet application and wound packing with hemostatic gauze.7 The acronym STOP stands for: S earching the patient at risk of coagulopathic bleeding, T reating the coagulopathies as soon as they develop, O bserving the response to interventions P reventing secondary bleeding coagulopathies.5,8
STOP the Bleed also recommends installation of bleeding control kits in plain view at public places, such as airports, federal buildings, heavily populated public places, malls and sports arenas, next to automated external defibrillators for public access.7 Over the years, the use of tourniquets has been controversial due to the complication of resultant tissue ischemia leading to amputation.7 The use of tourniquets in controlling extremity hemorrhage dates back to the 17th century but was strongly discouraged during World War I after military personnel reported complications of nerve damage and limb loss. The continued debate during World War II, the Korean War and the Vietnam War halted after the conflicts in Afghanistan and Iraq yielded more data regarding tourniquet use in a significant number of peripheral arterial injuries as a result of explosive devices. A prospective study at a combat support hospital in Baghdad in 2006 by Kragh and colleagues showed that the morbidity risk was low, and there was a survival benefit when tourniquets were used correctly.9
The University of Texas San Antonio Office of Medical Directors conducted a study to determine the curriculum of hemorrhagic control education to assess a layperson’s willingness to respond to a traumatic medical emergency and their ability to use a tourniquet. Individuals with medical health certificates were excluded from this study. Pre-event questionnaires were used to assess participants’ knowledge and comfort level with tourniquet use followed by a 20-minute didactic instruction on hemorrhagic control techniques and hands-on training with tourniquet placement on adult and child mannequins. Of the 218 participants, 64.2% responded “yes” to using a tourniquet in real life before training, and 95.6% responding “yes” to using a tourniquet in real life after training, showing a significant improvement in the participants’ comfort level of using the tourniquet in real life.10 In addition, a randomized clinical trial performed by Goralnick showed that a one-hour in-person training course is efficacious in retaining the proper tourniquet skills for three to nine months, and suggests a refresher training courses in individuals aged 18 to 55 years.11 ■
Data Show Benefits of Early Testing for Small Bowel Obstructions
By MONICA J. SMITH
Atlanta—The availability of gastrografin small bowel follow-through (G-SBFT) shifted small bowel obstruction from a condition treated surgically to one of watchful waiting. Although optimal timing for G-SBFT has been unclear, new research indicates ordering the procedure early offers clear benefits and no disadvantages.
“Some data shows that a significant proportion of small bowel obstructions will resolve after 48 hours, suggesting that we should observe these patients longer in an attempt to avoid an operation,” said Andrew Licata, MD, a surgical resident at Eastern Virginia Medical School, in Norfolk. He presented the research at the 2021 Southeastern Surgical Congress (SESC).
“But there is also data that suggests delaying surgery more than 48 hours in patients who will inevitably require an operation is associated with an increase in their overall morbidity,” Dr. Licata said. “So when should we be performing the test? That’s what we sought to discover.”
To do so, Dr. Licata and his colleagues retrospectively reviewed data on patients ages 18 to 89 years who were admitted to any of 13 Sentara facilities with a diagnosis of small bowel obstruction between 2012 and 2019. They divided the patients into two categories: those with a SBFT within 48 hours and those whose SBFT was ordered later than 48 hours.
The primary outcomes were hospital length of stay and total hospital costs. Secondary outcomes were operative intervention, 30-day mortality and 30-day readmission. 548 patients who met the inclusion criteria, 391 (71%) fell into the early category and 157 (28%) into the later group. The average hospital stay was five days, average cost was $20,000 and about 24% of patients ultimately required surgery.
“When we split our patients into the early and late categories, we found those in the early group had a significantly shorter hospital stay—four days versus eight,” Dr. Licata said. Costs were significantly less in the early G-SBFT group, averaging $17,000 compared with about $33,000 in the late group, and patients in the early group were less likely to undergo surgery than those in the late group, at 20% and 31%, respectively.
“Looking specifically at those patients who had an operation, those in the early group spent less than the later group for their hospital stay, $50,000 compared with $80,000, and had a shorter hospital stay, nine days compared to 15,” Dr. Licata said.
These differences were also seen in patients who did not require surgery. Patients with an earlier SBFT cost less for care and had a shorter hospital stay than those whose SBFT happened later.
Based on these findings, Dr. Licata and his colleagues concluded that ordering a SBFT within 48 hours can decrease length of stay, cost and rate of operative intervention without increasing readmission rates or mortality.
“We feel that delaying SBFT really only delays an operative intervention. Delaying that SBFT did not give patients
—Andrew Licata, MD
continued on page 15
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are on the liver transplant waitlist that will never be offered an organ and will die on the waiting list,” said Dr. Quintini. “Normothermic machine perfusion is a game-changer in the field of organ transplantation.”
NMP is a method of organ preservation that provides oxygen and nutrition during organ preservation and allows aerobic metabolism. “The machine allows livers to be kept outside of the body in near-physiological conditions, similar to those found in the body, with oxygenated blood that is pumped at body temperature through the organ,” said Dr. Quintini. “I tell the patient that we maintain the organ alive, for lack of a better term, during the preservation time, as opposed to maintaining the organ on ice and cooling it down to near freezing temperatures [as is usually done in transplants].”
In the study, conducted at Cleveland Clinic, 21 human livers declined for transplantation were enrolled for assessment with NMP. Reasons for discard included long warm ischemia time in donors after circulatory death, high degree of steatosis, hypernatremia, hyperbilirubinemia and severe hypertransaminasemia.
During NMP, the researchers evaluated the viability of the livers for transplant by assessing bile production rate, perfusate lactate clearance rate, hemodynamics and liver morphology. The researchers discarded six livers after NMP because of insufficient lactate clearance, limited bile production, or moderate macrosteatosis, leaving 15 deemed suitable for transplant. The livers deemed suitable for transplant included seven donors after circulatory death with 13 to 46 minutes of donor warm ischemia time and cold ischemia time that ranged from three hours and 41 minutes to seven hours and 42 minutes. NMP duration ranged from three hours and 49 minutes to 10 hours and 29 minutes without technical problems or adverse events. MELD score before transplantation ranged from 15 to 23.
Patients experienced good graft and transplant outcomes. There were no intraoperative or major early postoperative complications in any of the recipients of the liver transplants, and no primary non-function occurred after transplantation. Seven livers had early allograft dysfunction with fast recovery and one patient developed ischemic cholangiopathy after four months, which was treated with biliary stents. With a follow-up that ranged from five to 17 months, all other patients had good liver function.
“Our hope is that we can salvage and rescue many organs that are deemed untransplantable,” said Dr. Quintini. “Currently, about 20% of the livers are discarded in the United States. Assuming that we can salvage approximately 70% of these organs, we can potentially increase the number of liver transplants every year by 14%, which is approximately 1,200 patients per year.” Parsia Vagefi, MD, chief of the Division of Surgical Transplantation at UT Southwestern Medical Center, in Dallas, also believes that NMP is a gamechanger for liver transplants. In a recent study (Ann Surg 2020;272[3]:397-401), Dr. Vagefi and colleagues queried the United Network for Organ Sharing database to identify deceased donor livers procured from 2016 to 2019. Donor livers were divided by preservation method, either standard cold-static preservation (n=30,368) or NMP (n=228). The NMP group had a 3.5% discard rate versus 13.3% in the cold-static preservation group (P<0.0001), and this was despite NMP donors being older, more frequently donated after cardiac death, and having a greater donor risk index.
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3.0–3.5 minutes to peak sedation after initial 5 mg dose Rapid
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Indication: Byfavo is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Byfavo. • Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. • Byfavo has been associated with hypoxia, bradycardia, and hypotension.
Continuously monitor vital signs during sedation and through the recovery period. • Resuscitative drugs, and age- and size-appropriate equipment for bag/ valve/mask assisted ventilation must be immediately available during administration of Byfavo. • Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death.
The sedative effect of intravenous Byfavo can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. Contraindication: Byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Personnel and Equipment for Monitoring and Resuscitation: See Boxed Warning. Consider the potential for worsened cardiorespiratory depression prior to using Byfavo concomitantly with other drugs that have the same potential (eg, opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A during administration of Byfavo. Risks From Concomitant Use With Opioid Analgesics and Other SedativeHypnotics: See Boxed Warning. Hypersensitivity Reactions: Byfavo contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. Byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Neonatal Sedation: Use of benzodiazepines during the later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) in the neonate. Observe newborns for signs of sedation and manage accordingly. Pediatric Neurotoxicity: Published animal studies demonstrate that anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term of this is not clear. However, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through
Dr. Vagefi was also a co-author on the PROTECT trial presented at the 2021 American Transplant Congress (abstract 297). In this trial, NMP was pitted against ischemic cold storage for liver transplants and was found to reduce early allograft dysfunction (17.3% vs. 30.5%; P=0.009) and ischemic biliary complications at six (1.3% vs. 8.5%; P=0.004) and 12 months (2.6% vs. 9.9%; P=0.010).
“I think [NMP] is going to change a lot of how we practice,” said Dr. Vagefi. ■
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more time to resolve their obstruction; in fact, these patients had a higher rate of operative intervention,” Dr. Licata said. “Ordering the SBFT early simply allows us to decide whether or not they need surgery more quickly, and to get them the treatment they need to get them out of the hospital with less expense.”
Dr. Licata said that to the best of his knowledge, this is the largest multicenter study to date showing the benefits of SBFT. He also noted that a similar study published shortly after his abstract was submitted to the SESC had similar findings using an even earlier cutoff for early intervention: 12 hours.
Deborah Martin, MD, an acute care surgeon with Northside Hospital in Atlanta, commented that the paper is timely because small bowel obstruction is commonly seen by general surgeons. ”In patients who present with a closed loop obstruction or complete obstruction, ischemia, necrosis, perforation— the management is straightforward—we take them right to the OR. The remaining patients are the ones who present the challenge, so in this setting, gastrografin SBFT has been a wonderful tool to help us with our surgical decision making,” she said.
But Dr. Martin did ask if there are potential complications associated with SBFT that would be reasons not to order one.
Dr. Licata said there are potential complications and SBFT is not something that should be ordered blindly. “Especially in older patients, it may not be a good idea to order an SBFT in the middle of the night with less staff because there’s certainly a risk of aspiration.” ■
off . Rapid
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One sedative. Many patients.™
age in humans. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, Decisions regarding the timing of any elective procedures requiring anesthesia the potential risks. Adverse Reactions: of patients (N=630) receiving Byfavo 5-30 mg (total dose) and undergoing colonoscopy (two studies) or bronchoscopy (one study) were: hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. Pregnancy effects of Byfavo on pregnancy. Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression. Lactation—Monitor infants exposed to Byfavo through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours after Byfavo administration. Pediatric Use—Safety and effectiveness in pediatric patients have not been established. Byfavo should not be used in patients less than Geriatric Use—No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, there is a potential for greater sensitivity (eg, faster onset, oversedation, confusion) in some older individuals. Administer supplemental doses of Byfavo slowly to achieve the level of sedation required and monitor all patients closely for cardiorespiratory complications. Hepatic Impairment—In patients with severe hepatic impairment, the dose of Byfavo should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications. Abuse and Dependence: Byfavo is a federally controlled substance (CIV) because it contains remimazolam which has the potential for abuse and physical dependence.
Please see the Brief Summary of Prescribing Information for Byfavo on next page. ASA=American Society of Anesthesiologists Physical Status. of Alertness/Sedation. 1. 2. Pastis NJ, et al. Chest 3. Rex DK, et al. Gastrointest Endosc 4. Data on File. Acacia Pharma Inc. 5. Pambianco D, Cash B. Tech Gastrointest Endosc.
Same-Day Discharge for Lap Colectomy Safe in Select Patients
continued from page 1
no significant comorbidities, lived within 30 minutes of the hospital and did not require creation of a new ileostomy. Patients were asked if they preferred to go home or be admitted.
All patients underwent remote followup with a mobile health app or daily telephone call from their surgeon.
Two patients returned to the emergency department within 72 hours of discharge—one for urinary retention and the other with an anastomotic leak, which was managed conservatively.
“Same-day discharge can be done safely with either an mHealth phone app or telephone calls for remote follow-ups, which significantly reduces the resource burden but with the same results,” said lead author Lawrence Lee, MD, PhD, an assistant professor of surgery, McGill University Health Centre, in Montreal, in an email to General Surgery News.
Co-investigator Jules Eustache, MD, a general surgery resident at McGill University, presented the study at SAGES.
Overall, 10 patients, or 12.7%, returned to hospital within one month of surgery, consistent with previously published studies of colorectal surgery, said the investigators.
The study started before the pandemic but picked up new urgency as COVID-19 put pressure on hospital systems. In the first wave, many patients were afraid to stay in the hospital, and Quebec’s ministry of health asked hospital staff to reserve capacity for patients with illnesses related to the virus, said Dr. Lee.
As a result, SDD enabled more patients to have surgery that they otherwise would have waited for, said Dr. Lee.
“It is not an exaggeration to say that a good proportion of our SDD patients would not have had their surgery done in a timely manner if the SDD hadn’t existed,” he said.
The investigators set out to study SDD
for Byfavo© • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Byfavo. • Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. • Byfavo has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period. • Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of Byfavo. Concomitant use of benzodiazepines, including Byfavo, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. Hypnotics Pregnancy—Risk Summary:
—Deborah S. Keller, MD
because McGill’s experience with an enhanced recovery after surgery protocol, or ERAS, showed that most of the patients remained in hospital after a laparoscopic colectomy only to pass gas. But research from other institutions demonstrated that patients could be safely discharged before their GI function returned.
The development of mHealth apps around the same time made remote post-discharge monitoring possible, said Dr. Lee.
The investigators felt the combination of these principles suggested that SDD in these patients could be safe, he added.
Patients underwent laparoscopic colectomy, using a Pfannenstiel incision when extraction was necessary. After surgery, patients spent four to six hours in the recovery room. To be discharged, they had to be able to tolerate a liquid diet, have
continued on the following page
Clinical Considerations—Fetal/Neonatal Adverse Reactions Data— Human Data: Lactation—Risk Summary: Pediatric Use Geriatric Use Hepatic Impairment Clinical Presentation Management of Overdosage Alcohol and Current Medications— Pregnancy Lactation—Advise
Creating Better Surgeons Through Better Learning
By KATE O’ROURKE
At the joint annual meeting of the Central Surgical Association and Midwest Surgical Association, David Farley, MD, president of the Midwest Surgical Association and an emeritus professor of surgery and former general surgery program director at the Mayo Clinic in Rochester, Minnesota, devoted part of his presidential address to how to get learners to efficiently acquire knowledge and skill, and ultimately perform surgery better.
Dr. Farley provided four background points. • First, a learner needs an experience and then must code that memory with the brain’s neural pathways; memories can be consolidated and refined and ultimately retrieved. “The emphasis must be on assisting the learner in creating their own neural pathways and practicing to retrieve those memories,” said Dr. Farley. • The second background point is that teachers can offer a variety of experiences but learners must engage in the experience, code the memory, consolidate it and retrieve it for learning to occur. • The third background point is that a test creates a stronger memory that eventually will be easier to retrieve over time. A test forces a learner to go back into their mind and retrieve data, skill or information, and the effort it takes to go back and generate this memory is key to burning that fact or skill into the working memory (neural pathways) and something ready to use on demand. • Fourth, sequential learning sessions coupled with frequent tests, quizzes, challenges, or self-reflection is not only useful, it enhances learning, memory retrieval, and, ultimately, performance.
Dr. Farley said based on the four background points and education research over the last few decades, he suggests that surgeons and educators spend serious time on three things: praising learner effort, offering detailed individualized feedback, and repeatedly challenging learners.
In terms of praising effort, Dr. Farley said that today in 2021, we know that intelligence, talent and ability is not fixed. If learners understand that effort is necessary and mandatory to make gains in surgery, said Dr. Farley, they will understand that the sky is the limit if they put forth effort. Educators, he said, should praise effort, not talent or skill.
“Praising the learning process and effort they put into improving is positive feedback without the burden of perfection,” said Dr. Farley. “Praising effort gives positive feedback and subtly asks learners to continue to challenge themselves. … Moving more learners into a growth mindset where perfection is not expected and mistakes are known to happen will allow most learners to accelerate forward and challenge themselves to get better.”
R— s too mply d. t
—David Farley, MD
Dr. Farley said that in 15 years as a general surgery program director at the Mayo Clinic-Rochester, the number one complaint students, residents and fellows gave him of the attending surgeon was not enough feedback provided in the operating room. “Many attending surgeons are reluctant to speak up in the OR—either afraid to come across as too tough or harassing, or they simply are fixated on the task at hand,” said Dr. Farley. This is unfortunate, given that feedback is critical to any learner trying to improve.
“Using detailed feedback within focused practice sessions, coaches effectively improve their players’ performance in crucial areas and skills where they are underperforming,” said Dr. Farley. “Deliberate practice offering detailed feedback to learners in surgical simulation labs, cadaver labs, M&M conferences etc. can offer repeated attempts at correcting flaws, gaining fluency and finesse, and honing in on better judgment and decision-making.”
Dr. Farley said that individualized and focused feedback is memorable, and offering that feedback with multiple practice repetitions in a sequential fashion creates an optimal learning environment. “Surgeons must learn and simply be willing to offer better feedback in the OR. Somehow. Someway,” said Dr. Farley. He said feedback works best when it is intermittent and not always immediately after an action. “With more ready access to recording video in our operating rooms, having learners view their own efforts is useful,” said Dr. Farley. “Better yet, asking the learner to edit out a few clips from the procedure for the staff surgeon to review with them or voice over is effective use of surwith them geon time and offers the learner superb feedgeon ti back—available 24/7 at minimal cost.” back— The third tip that Dr. Farley provided was Th to challenge learners. “Considering distribto ch utive learning offers trainees greater long utive term memory acquisition and better retrievterm m al, it makes sense to challenge our learnal ers with multiple repetitions spread out over time,” said Dr. Farley. He said as long as students understand that repeated challenges or quizzes or questions are offered as part of a learning strategy, and that no one expects perfection, learners greatly respect staff that are taking the time and effort to help them improve.
“The next time you are in your chief conference, or your M&M conference or your basic science conference: make your point,” said Dr. Farley. “And if it is a great point or an important point or if it might save somebody’s life, make that point again—in the form of a question or quiz or fill-in-the-blank comment at the next conference two days later. Make your point, and your test, two weeks later at some other conference or walking down a hallway with a student.” Ultimately, said Dr. Farley, the surgical coach needs to teach learners how to quiz and challenge themselves.
Dr. Farley said educators should ask learners at least a question or two each day. “Make it a fill-in-the-blank or open-ended question to force them to generate and retrieve that memory in their brain,” said Dr. Farley. “Multiple choice questions and true/false questions do not mandate generational type recall.”
Repetition is the mother of learning, said Dr. Farley. ■
Colectomy
continued from page 17
their pain controlled with oral analgesia, and could ambulate and void independently after removal of any catheters.
Patients were only discharged on the same day if they preferred to go home. The main reason for admission was patient preference, followed by intraoperative complications that required monitoring, nausea, poorly controlled pain and urinary retention.
Patient Perspectives Should Be Considered
group of the Association of Coloproctology of Great Britain and Ireland, said patients want to stay in hospital until they felt ready to go home—“not when clinicians felt they were ready. If that was day 3, then great, but if it was day 10, then also great.”
Deborah S. Keller, MD, an assistant professor of surgery at the University of California Davis Medical Center, said patients need to be asked if they are comfortable going home on the same day as their surgery. They often feel rushed by ERAS and SDD policies, she said.
Dr. Keller said patients being discharged on the same day need in-depth communication with their surgeon and wearables that are actively monitored and addressed in timely fashion, and they must be given well-defined pathways to contact health care providers with questions.
“There are few places where all these are currently feasible, but they are necessary for SDD to be safe,” she said.
“It just takes one patient having a major complication at home where they cannot get through to their provider or get fast-tracked through the emergency department, and that morbidity becomes a preventable mortality for this concept to go up in flames, so it is critical that implementation is appropriate,” she said.
Findings Similar to French Experience
The McGill results are similar to those published by French surgeons in 2019 (Ann Surg 2019; 270[2]:317-321). The French team used a more resource-intensive follow-up after patients were discharged. Trained nurses spoke with patients daily for the first five days and visited them at home throughout the first week. Patients also underwent regular blood tests.
This approach is probably not feasible in North America, said Dr. Lee.
The McGill team did not measure the burden of the interventions on the health care team and did not assess whether patients preferred the mobile app or telephone. ■
