SAGES perspective: professional medical associations, commercial interests, and conflicts of interest.

BACKGROUND: Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound. METHODS: SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009-2021. RESULTS: Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4-6.2% (2008-2010) to 1.2-2.2% (2011-2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity. CONCLUSIONS: The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.

Concordance of financial disclosures among faculty at the 2018-2020 SAGES annual meetings.

BACKGROUND: Financial relationships with industry may bias educational content delivered by physicians. SAGES strives to mitigate potential bias, relying on physician self-reporting. Retrospective review of relationships is possible using the Open Payments Database (OPD), a public record of industry-reported payments to US physicians. We aimed to evaluate the effectiveness of the SAGES disclosure process by comparing faculty disclosures to SAGES, faculty disclosures within presentations, and OPD records among speakers at the 2018-2020 SAGES meetings. METHODS: We reviewed all presentations from the SAGES 2018-2020 Annual Meetings. For each invited presentation, all slide-disclosed relationships were recorded. For US physicians, we queried the OPD and recorded relationships ≥ $500 USD in the calendar year prior to presentation. We compared the slide-disclosed relationships with OPD-reported relationships and with those provided to SAGES during the faculty disclosure process. We surveyed a sample of the 2020 annual meeting speakers to analyze potential reasons for discordance. RESULTS: From 2018 to 2020, there were 1,355 invited presentations, of which 1,234 (91%) were available for review. Disclosure slides were present in 1,098 (89%), increasing from 86% in 2018 to 93% in 2020. The proportion of speakers with OPD-reported relationships ≥ $500 increased from 54% in 2018 to 66% in 2020. The total value of OPD relationships decreased from $5.9 million (2018) to $3.3 million (2020) with a concomitant decrease in the proportion with high discordance from 9% in 2018 to 5% in 2020. Among the 2020 speakers with high discordance, the most common explanations for discordance were being unaware of payment or payment outside the 12-month timeframe (55%). CONCLUSIONS: Discordance between financial disclosures reported to SAGES and OPD highlight the need for improvements in the faculty disclosure process. SAGES will continue to streamline this process by incorporating faculty review of their OPD disclosures to ensure all educational programs remain free of commercial bias.

Ethical considerations for allocation of scarce resources and alterations in surgical care during a pandemic.

The COVID-19 pandemic caused by SARS-CoV-2 is unprecedented in modern history. Its effects on social behavior and health care delivery have been dramatic. The resultant burden of disease and critical illness has outpaced the diagnostic, therapeutic, and health care professional resources of many clinics and hospitals. It continues to do so globally. The allocation of hospital beds and ventilators, personal protective equipment, investigational therapeutics, and other scarce resources has required difficult decisions. Clinical and surgical practices which are standard in normal times may not be standard or safe during the COVID-19 crisis. How can we best adapt as physicians and surgeons? What foundational ethical principles and systems of principle application can help guide our decision-making? Fortunately, a large body of work in medical ethics addresses these questions. Unfortunately, many surgeons and other health care professionals are probably not as familiar with these concepts. This brief communication is intended to provide a concise explanation of ethical considerations which readers may find helpful when addressing allocation of scarce resources and alterations in surgical care brought on by the current pandemic.

Informed consent: a shared decision-making process that creates a new professional obligation for care.

This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).

The Science Behind Mini-Laparoscopic Cholecystectomy.

BACKGROUND: Mini-laparoscopy (Mini) was pioneered more than 20 years ago. Newer generation mini instruments have recently become available with improved effector tips, a choice of shaft diameters and lengths, better shaft insulation and electrosurgery capability, improved shaft strength and rotation, more ergonomic handles, low-friction trocar options, and improved instrument durability. Whether the use of mini instruments, particularly newer generation instruments, offers advantages for laparoscopic cholecystectomy is the subject of this review. MATERIALS AND METHODS: The literature was searched for level I data comparing mini-laparoscopic cholecystectomy (Mini LC) to standard laparoscopic cholecystectomy (Std LC). Three systematic reviews and 19 randomized clinical trials were identified and these were studied to evaluate the science behind Mini LC. RESULTS: Mini LC requires conversion to Std LC in 12.3% of patients. Mini LC and Std LC require conversion to open cholecystectomy at the same rate (2-3%). As compared to Std LC, Mini LC: (1) takes 3.4-4.9 minutes longer to perform; (2) has the same rate of intraoperative and postoperative complications; (3) may result in slightly less pain in the first 24 hours after surgery; (4) has the same duration of hospital stay, pain scores 1-28 days after surgery, time to return to activity, time to return to work, and postoperative quality of life 10 days after surgery; (5) provides a better early cosmetic result (as graded by patients and by blinded observers); and (6) provides no apparent difference in late cosmesis (as evaluated 6-12 months postop). There are minimal level I data published on the effects of newer mini instruments for laparoscopic cholecystectomy. CONCLUSION: When applied to elective laparoscopic cholecystectomy, the use of mini-laparoscopic instruments results in a slightly longer operative procedure (3-5 minutes), slightly less immediate postoperative pain (in the first 24 hours), and a better early cosmetic result, with no other apparent significant differences. Additional data are needed from large, well-conducted studies of Mini LC to resolve several unanswered questions, including the role of newer mini instruments.

A comprehensive process for disclosing and managing conflicts of interest on perceived bias at the SAGES annual meeting.

INTRODUCTION: The relationship between the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and its industry partners has been longstanding, productive technologically, and beneficial to patient care and education. In order to both maintain this important relationship to honor its responsibility to society for increasing transparency, SAGES established a Conflict of Interest Task Force (CITF) and charged it with identifying and managing potential conflicts of interest (COI) and limiting bias at the SAGES Annual Scientific Meetings. The CITF developed and implemented a comprehensive process for reporting, evaluating, and managing COI in accordance with (and exceeding) Accreditation Council for Continuing Medical Education guidelines. METHODS: From 2011 to 2013, all presenters, moderators, and session chairs received proactive and progressively increasing levels of education regarding the CITF rationale and processes and were required to disclose all relationships with commercial interests. Disclosures were reviewed and discussed by multiple layers of reviewers, including moderators, chairs, and CITF committee members with tiered, prescribed actions in a standardized, uniform fashion. Meeting attendees were surveyed anonymously after the annual meeting regarding perceived bias. The CITF database was then analyzed and compared to the reports of perceived bias to determine whether the implementation of this comprehensive process had been effective. RESULTS: In 2011, 68 of 484 presenters (14 %) disclosed relationships with commercial interests. In 2012, 173 of 523 presenters (33.5 %) disclosed relationships, with 49 having prior review (9.4 %), and eight required alteration. In 2013, 190 of 454 presenters disclosed relationships (41.9 %), with 93 presentations receiving prior review (20.4 %), and 20 presentations were altered. From 2008 to 2010, the perceived bias among attendees surveyed was 4.7, 6.2, and 4.4 %; and in 2011-2013, was 2.2, 1.2, and 1.5 %. CONCLUSION: It is possible to have a surgical meeting that includes participation of speakers that have industry relationships, and minimize perceived bias.

Mini-Laparoscopy: Instruments and Economics.

Mini-laparoscopy (Mini) was pioneered more than 20 years ago, initially with instruments borrowed from other specialties and subsequently with tools designed specifically for Mini. Early adoption of Mini was inhibited though by the limitations of these first-generation instruments, especially functionality and durability. Newer generation Mini instruments have recently become available with improved effector tips, a choice of shaft diameters and lengths, better shaft insulation and electrosurgery capability, improved shaft strength and rotation, more ergonomic handles, low-friction trocar options, and improved instrument durability. Improvements are also occurring in imaging and advanced energy for Mini. The current status of mini-laparoscopy instruments and economics are presented.

"Big Operations Using Mini Instruments": The Evolution of Mini Laparoscopy in the Surgical Realm.

Laparoscopy using miniature (2-3.5 mm) instruments was introduced in the late 1980s and early 1990s. Though mini laparoscopy (Mini) created new opportunities for surgical diagnosis and therapy, the limitations of early instruments inhibited widespread adoption. This is no longer the case. Mini is enjoying a renaissance, due to several factors: the maturation of minimally invasive surgery (MIS), the failure of laparoendoscopic single-site surgery (LESS) and natural orifice transluminal endoscopic surgery (NOTES) platforms to achieve early expectations, and the recent significant improvements in Mini instrument functionality and durability. As a result, Mini is being increasingly applied to pediatric and adult procedures across specialties. To assess the current status of Mini laparoscopy, the Society of Laparoendoscopic Surgeons (SLS) and the Florida Hospital Nicholson Center convened an international symposium in February 2015. This report shares highlights from that symposium, "Big Operations Using Mini Instruments."

Ethical considerations regarding the implementation of new technologies and techniques in surgery.

Ethical considerations relevant to the implementation of new surgical technologies and techniques are explored and discussed in practical terms in this statement, including (1) How is the safety of a new technology or technique ensured?; (2) What are the timing and process by which a new technology or technique is implemented at a hospital?; (3) How are patients informed before undergoing a new technology or technique?; (4) How are surgeons trained and credentialed in a new technology or technique?; (5) How are the outcomes of a new technology or technique tracked and evaluated?; and (6) How are the responsibilities to individual patients and society at large balanced? The following discussion is presented with the intent to encourage thought and dialogue about ethical considerations relevant to the implementation of new technologies and new techniques in surgery.

Factors Associated with Mortality after Percutaneous Endoscopic Gastrostomy.

Introduction: Percutaneous endoscopic gastrostomy (PEG) is a common procedure performed world-wide on patients with different comorbidities, with many indications and overall low morbidity. However, studies showed an elevated early mortality in patients undergoing PEG placement. In this systematic review, we review the factors associated with early mortality after PEG. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. The methodological index for nonrandomized studies (MINORS) score system was used to perform qualitative assessment of all included studies. Recommendations were summarized for predefined key items. Results: The search found 283 articles. A refined total of 21 studies were included; 20 studies cohort studies and 1 case-control study. For the cohort studies, MINORS score ranged from 7 to 12 out of 16. The single case-control study scored 17 out of 24. The number of study patients ranged from 272 to 181,196. Thirty-day mortality rate varied from 2.4% to 23.5%. Albumin, age, body mass index, C-reactive protein, diabetes mellitus, and dementia were the most frequently associated factors to early mortality in patients undergoing PEG placement. Five studies reported procedure related deaths. Infection was the most commonly reported complication of PEG placement. Conclusions: PEG tube insertion is a fast, safe and effective procedure, but is not free of complications and can have a high early mortality rate as demonstrated in this review. Patient selection should be a key factor and the identification of factors associated with early mortality is important in the elaboration of a protocol to benefit patients.

Which Cholecystectomy Technique Would Surgeons Prefer on Themselves?

BACKGROUND: As the minimally invasive surgery revolution approaches 30 years, many techniques are now available for cholecystectomy: open, conventional laparoscopy, ini-laparoscopy, single incision, robotic, and natural orifice. Although much has been published about patient preferences regarding these techniques, less is known about surgeon perceptions and preferences. The aim of this study was to survey attending and trainee surgeons about which cholecystectomy technique they would prefer for themselves and what factors determine their decision. METHODS: Attending fellow and resident surgeons globally completed a Google Forms online questionnaire that was posted in 3 closed groups for surgeons on Facebook and WhatsApp. RESULTS: The online questionnaire was completed by 600 surgeons (453 attending surgeons and 147 residents/fellows). Most respondents were male individuals (87.6% of attending surgeons, 78.2% of trainee surgeons). The most common age range of respondents was 31 to 40 years. Surgeon response was global, with especially good representation from North American, Asian, and European physicians. When conventional laparoscopy, mini-laparoscopy, and robotic surgery were the options offered for cholecystectomy, 58.5% of trainees and 45.7% of surgeons chose conventional laparoscopy. When asked if they would consider a single-incision or natural orifice transluminal endoscopic surgery approach, 91.5% answered no. When asked which technique they would prefer if hypothetically all techniques were equally safe, about three-fourths chose either conventional laparoscopy (46%) or mini-laparoscopy (27%). When asked to rank which factors they considered most important in choosing a surgical technique, surgeon experience (52%) and safety of the procedure (45%) were the 2 most important factors. CONCLUSIONS: When an international sample of 600 attending and trainee surgeons were asked about undergoing a cholecystectomy on themselves, most chose either conventional laparoscopy or mini-laparoscopy as their preferred access technique. Single-incision and natural orifice transluminal endoscopic surgery approaches were unpopular. Surgeons ranked the experience of the operating surgeon and safety of the procedure as the most important factors guiding their decision.

Survey of Social Media Use for Surgical Education During Covid-19.

OBJECTIVE: To evaluate the use of social media platforms by medical students, surgical trainees, and practicing surgeons for surgical education during the Covid-19 pandemic. METHODS: An online, 15-question survey was developed and posted on Facebook and WhatsApp closed surgeon groups. RESULTS: The online survey was completed by 219 participants from South America (87%), North America (7%), Europe (5%), Central America, and Asia. Respondents included medical students (6.4%), surgical residents/fellows (24.2%), and practicing surgeons (69.4%). The most common age group was 35-44 years. When asked which social media platforms they preferred, the video sharing site YouTube (33.3%), the messaging app WhatsApp (21%), and "other" (including videoconferencing sites) (22.3%) were most popular. Respondents reported using social media for surgical education either daily (38.4%) or weekly (45.2%), for an average of 1-5 hours/week. Most (85%) opined that surgical conferences that were cancelled during the pandemic should be made available online, with live discussions. CONCLUSION: Social media use for surgical education during Covid-19 appears to be increasing and evolving.

Which Cholecystectomy do Medical Students Prefer?

INTRODUCTION: This study was undertaken to identify which minimally invasive technique medical students prefer for cholecystectomy and what factors determine their decision. METHODS: Brazilian medical students watched a video reviewing the advantages and disadvantages of six different surgical approaches to cholecystectomy: open surgery, conventional laparoscopy, mini-laparoscopy (MINI), single-incision laparoscopic surgery, natural-orifice transluminal endoscopic surgery, and robotic surgery. Respondents then answered questions about hypothetical situations in which the participants would be submitted to elective cholecystectomy. RESULTS: One hundred eleven medical students completed the survey, 60 females (54%) and 51 males (46%). Most students were 19-26 years old. When asked whether they would consider an open cholecystectomy if minimally invasive surgery (MIS) techniques were available, only 9% answered yes. Senior medical students were the least willing to consider open surgery (P = .036). When asked if they would prefer conventional laparoscopy, MINI, or robotic surgery for their cholecystectomy, 85% of the women and 63% of the men chose MINI (P = .025). When asked if they would consider a single-incision laparoscopic surgery or natural-orifice transluminal endoscopic surgery approach, 94 respondents (84%) answered no. When asked to rank which factors they consider the most important when choosing a surgical technique, they ranked safety of the procedure first (58%) and surgeon experience second (30%). CONCLUSION: When Brazilian medical students were asked to select a surgical approach for cholecystectomy, most chose MINI. The preference for MINI was strongest amongst female medical students. Both female and male medical students ranked safety as the most important factor.

Intragastric Balloon for Overweight Patients.

BACKGROUND AND OBJECTIVES: Current treatments for overweight adults include reduced-calorie diet, exercise, behavior modification, and selective use of medications. Many achieve suboptimal results with these measures and progress to obesity. Whether the intragastric balloon (IGB), a reversible device approved for treatment of obesity, is a safe and effective option in overweight adults is less well studied. We conducted a study to prospectively analyze the safety and effectiveness of IGB in overweight adults, to compare the results to a simultaneously studied cohort of obese patients, and to share procedural tips for safe IGB placement and removal. METHODS: One hundred thirty-nine patients were evaluated in this prospective, nonrandomized study. Twenty-six overweight [body mass index (BMI), 26-30)] and 113 obese (BMI > 30) patients underwent outpatient, endoscopic IGB placement under intravenous sedation. The IGB was filled with a 550-900 mL (average, 640 mL) solution of saline, radiological contrast, and methylene blue, with an approximate final proportion of 65:2:1. The patients were followed up at 1-2 weeks and then monthly for 6 months. At 6 months, they underwent IGB removal via an esophageal overtube to optimize safety, and then they were observed for 6 more months. RESULTS: IGB time was 190 ± 36 d in the overweight patients and 192 ± 43 d in the obese patients. Symptoms of IGB intolerance included nausea and pain, which were transiently present in 50-95% of patients for several days, and necessitated early IGB removal in 6% of patients. There were no procedure-related complications and no IGB-related esophagitis, erosion, perforation, or obstruction. The percentage of excess weight loss (EWL%) was 96 ± 54% in the overweight group and 41 ± 26% in the obese group (P < 0.001). CONCLUSION: In overweight adults failing standard treatments, IGB placement for 6 months had an acceptable safety profile and excellent weight loss.

Low-Friction Minilaparoscopy Outperforms Regular 5-mm and 3-mm Instruments for Precise Tasks.

BACKGROUND AND OBJECTIVES: Therapeutic laparoscopy was incorporated into surgical practice more than 25 y ago. Several modifications have since been developed to further minimize surgical trauma and improve results. Minilaparoscopy, performed with 2- to 3-mm instruments was introduced in the mid 1990s but failed to attain mainstream use, mostly because of the limitations of the early devices. Buoyed by a renewed interest, new generations of mini instruments are being developed with improved functionality and durability. This study is an objective evaluation of a new set of mini instruments with a novel low-friction design. METHOD: Twenty-two medical students and 22 surgical residents served as study participants. Three designs of laparoscopic instruments were evaluated: conventional 5mm, traditional 3 mm, and low-friction 3 mm. The instruments were evaluated with a standard surgical simulator, emulating 4 exercises of various complexities, testing grasping, precise 2-handed movements, and suturing. The metric measured was time to task completion, with 5 replicates for every combination of instrument-exercise-participant. RESULTS: For all 4 tasks, the instrument design that performed the best was the same in both the medical student and surgical resident groups. For the gross-grasping task, the 5-mm conventional instruments performed best, followed by the low-friction mini instruments. For the 3 more complex and precise tasks, the low-friction mini instruments outperformed both of the other instrument designs. CONCLUSION: In standard surgical simulator exercises,low-friction minilaparoscopic instruments outperformed both conventional 3- and 5-mm laparoscopic instruments for precise tasks.

The Kraske procedure: a critical analysis of a surgical approach for mid-rectal lesions.

BACKGROUND AND OBJECTIVES: To analyze the Kraske procedure as an approach to mid-rectal disease. METHODS: Twenty-two patients underwent a Kraske procedure at either Duke University Medical Center, the Durham Veterans Administration Medical Center, or the Durham Regional Hospital between 1992 and 1997. The clinical and pathologic characteristics of these patients were retrospectively analyzed and compared with previous published series. RESULTS: Of the 22 patients, 13 underwent resection of an adenocarcinoma and 9 underwent resection of a villous adenoma. Post-operative complications included four fecal fistulas (two of which required a temporary diverting colostomy), two wound infections, two cases of urinary retention, and one case of transient fecal incontinence. CONCLUSIONS: The Kraske procedure minimizes exposure of mid-rectal lesions without the morbidity of a major laparotomy. However, it does carry a moderate complication rate and thus should be utilized selectively in managing patients with mid-rectal tumors not amenable to other treatment options.