SAGES White Paper on the importance of diversity in surgical leadership: creating the fundamentals of leadership development (FLD) curriculum.

BACKGROUND: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has long recognized and championed increasing diversity within the surgical workplace. SAGES initiated the Fundamentals of Leadership Development (FLD) Curriculum to address these needs and to provide surgeon leaders with the necessary tools and skills to promote diversity, equity, and inclusion (DEI) in surgical practice. In 2019, the American College of Surgeons issued a request for anti-racism initiatives which lead to the partnering of the two societies. The primary goal of FLD was to create the first surgeon-focused leadership curriculum dedicated to DEI. The rationale/development of this curriculum and its evaluation/feedback methods are detailed in this White Paper. METHODS: The FLD curriculum was developed by a multidisciplinary task force that included surgeons, education experts, and diversity consultants. The curriculum development followed the Analysis, Design, Development, Implementation and Evaluation (ADDIE) instructional design model and utilized a problem-based learning approach. Competencies were identified, and specific learning objectives and assessments were developed. The implementation of the curriculum was designed to be completed in short intervals (virtual and in-person). Post-course surveys used the Kirkpatrick's model to evaluate the curriculum and provide valuable feedback. RESULTS: The curriculum consisted of interactive online modules, an online discussion forum, and small group interactive sessions focused in three key areas: (1) increasing pipeline of underrepresented individuals in surgical leadership, (2) healthcare equity, and (3) conflict negotiation. By focusing on positive action items and utilizing a problem-solving approach, the curriculum aimed to provide a framework for surgical leaders to make meaningful changes in their institutions and organizations. CONCLUSION: The FLD curriculum is a novel leadership curriculum that provided surgeon leaders with the knowledge and tools to improve diversity in three areas: pipeline improvement, healthcare equity, and conflict negotiation. Future directions include using pilot course feedback to enhance curricular effectiveness and delivery.

Understanding Post-Esophagectomy Complications and Their Management: The Early Complications.

Esophagectomy is a technically complex operation performed for both benign and malignant esophageal disease. Medical and surgical advancements have led to improved outcomes in esophagectomy patients over the past several decades; however, surgeons must remain vigilant as complications happen often and can be severe. Post-esophagectomy complications can be grouped into early and late categories. The aim of this review is to discuss the early complications of esophagectomy along with their risk factors, work-up, and management strategies with special attention given to anastomotic leaks.

Impact of Morbid Obesity on Post-esophagectomy Leak Rate: a NSQIP Analysis.

BACKGROUND: Morbid obesity is becoming more prevalent and is a known risk factor for esophageal cancer. Esophagectomy in this population is technically more challenging than the non-obese, thus increasing the risks of surgery. This study hypothesizes that higher body mass index (BMI) is associated with higher anastomotic leak rates after esophagectomy. METHODS: This study is a retrospective review of patients undergoing esophagectomy in the National Surgical Quality Improvement Program (NSQIP) Targeted Esophagectomy database from 2016 to 2019. Patients were stratified by BMI < 35 versus BMI > 35, with the primary outcome being leak post-esophagectomy. Univariate analyses were performed for demographics and post-operative outcomes, and multivariate analyses were performed specifically for the primary outcome of anastomotic leak (all diagnoses and malignancy/dysplasia subgroup). This study was approved by the Institutional Review Board. RESULTS: Of 4165 patients, 439 (10.5%) had a BMI > 35. Patients with BMI > 35 were often younger (mean age 60 vs 64 years, p < 0.001), White (p < 0.001), female (p < 0.001), non-smoker (p < 0.001), diabetic (p < 0.001), with hypertension (p < 0.001), and ASA ≥ 3 (p < 0.001). There were no differences between BMI groups with regard to indication for esophagectomy (malignancy/dysphasia vs other), conversion to open, mortality, or length of stay. The BMI > 35 cohort reported higher operative times (p < 0.001), open operative approach (p = 0.04), superficial surgical site infection (p < 0.001), return to operating room (p = 0.01), and leak (13.5% vs 10.1%, p = 0.01). BMI > 35 was not an independent predictor of leak for all diagnoses; however, the subgroup analysis of esophagectomy for malignancy/dysplasia demonstrated that BMI > 35 was predictive of leak (OR 1.42, 95% CI 1.05-1.91), as well as operative time and hypertension. CONCLUSION: Patients with a BMI > 35 and who undergo esophagectomy have a higher rate of anastomotic leak. BMI > 35 was also an independent predictor of leak when esophagectomy was performed for malignancy/dysplasia, but not for all diagnoses. The risk of anastomotic leak should be considered in morbidly obese patients undergoing esophagectomy, particularly for malignancy.

Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD).

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most common diseases in North America and globally. The aim of this guideline is to provide evidence-based recommendations regarding the most utilized and available endoscopic and surgical treatments for GERD. METHODS: Systematic literature reviews were conducted for 4 key questions regarding the surgical and endoscopic treatments for GERD in adults: preoperative evaluation, endoscopic vs surgical or medical treatment, complete vs partial fundoplication, and treatment for obesity (body mass index [BMI] ≥ 35 kg/m2) and concomitant GERD. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Recommendations for future research were also proposed. RESULTS: The consensus provided 13 recommendations. Through the development of these evidence-based recommendations, an algorithm was proposed for aid in the treatment of GERD. Patients with typical symptoms should undergo upper endoscopy, manometry, and pH-testing; additional testing may be required for patients with atypical or extra-esophageal symptoms. Patients with normal or abnormal findings on manometry should consider undergoing partial fundoplication. Magnetic sphincter augmentation or fundoplication are appropriate surgical procedures for adults with GERD. For patients who wish to avoid surgery, the Stretta procedure and transoral incisionless fundoplication (TIF 2.0) were found to have better outcomes than proton pump inhibitors alone. Patients with concomitant obesity were recommended to undergo either gastric bypass or fundoplication, although patients with severe comorbid disease or BMI > 50 should undergo Roux-en-Y gastric bypass for the additional benefits that follow weight loss. CONCLUSION: Using the recommendations an algorithm was developed by this panel, so that physicians may better counsel their patients with GERD. There are certain patient factors that have been excluded from included studies/trials, and so these recommendations should not replace surgeon-patient decision making. Engaging in the identified research areas may improve future care for GERD patients.

Pilot Study Showing Feasibility of Phosphoproteomic Profiling of Pathway-Level Molecular Alterations in Barrett's Esophagus.

(1) Background: Barrett's esophagus is a major risk factor for esophageal adenocarcinoma. In this pilot study, we employed precision mass spectrometry to map global (phospho)protein perturbations in Barrett's esophagus lesions and adjacent normal tissue to glean insights into disease progression. (2) Methods: Biopsies were collected from two small but independent cohorts. Comparative analyses were performed between Barrett's esophagus samples and adjacent matched (normal) tissues from patients with known pathology, while specimens from healthy patients served as additional controls. (3) Results: We identified and quantified 6810 proteins and 6395 phosphosites in the discovery cohort, revealing hundreds of statistically significant differences in protein abundances and phosphorylation states. We identified a robust proteomic signature that accurately classified the disease status of samples from the independent patient cohorts. Pathway-level analysis of the phosphoproteomic profiles revealed the dysregulation of specific cellular processes, including DNA repair, in Barrett's esophagus relative to paired controls. Comparative analysis with previously published transcriptomic profiles provided independent evidence in support of these preliminary findings. (4) Conclusions: This pilot study establishes the feasibility of using unbiased quantitative phosphoproteomics to identify molecular perturbations associated with disease progression in Barrett's esophagus to define potentially clinically actionable targets warranting further assessment.

SAGES Reimagining Education & Learning (REAL) project.

BACKGROUND: The COVID-19 pandemic has presented multiple challenges for health systems throughout the world. The clinical priorities of redirecting personnel and resources to provide the necessary beds, care, and staff to handle the initial waves of infected individuals, and the drive to develop an effective vaccine, were the most visible and rightly took precedent. However, the spread of the COVID-19 virus also led to less apparent but equally challenging impediments for healthcare professionals. Continuing professional development (CPD) for physicians and surgeons practically ceased as national societies postponed or canceled annual meetings and activities. The traditional in-person conferences were no longer viable options during a pandemic in which social distancing and minimization of contacts was the emerging norm. Like other organizations, The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) had to first postpone and then cancel altogether the in-person 2020 Annual Meeting due to the contingencies brought about by the COVID-19 pandemic. As a result, the traditional hands-on (HO) courses that typically occur as part of the Annual Meeting, could not take place. SAGES had already begun to re-structure these courses in an effort to increase their effectiveness (Dort, Trickey, Paige, Schwarz, Dunkin in Surg Endosc 33(9):3062-3068, 2019; Dort et al. in Surg Endosc 32(11):4491-4497, 2018; Dort, Trickey, Schwarz, Paige in Surg Endosc 33(9):3062-3068, 2019). The cancelations brought about by COVID-19 provided an opportunity to refine and to innovate further. METHODS: In this manner, the Re-imaging Education & Learning (REAL) project crystallized, an innovative effort to leverage the latest educational concepts as well as communication and simulation-based technologies to enhance procedural adoption by converting HO courses to a virtual format. RESULTS AND CONCLUSION: This manuscript describes the key components of REAL, reviewing the restructuring of the HO courses before and after the spread of COVID-19, describing the educational framework underlying it, discussing currently available technologies and materials, and evaluating the advantages of such a format.

Diversity in Scientific Discovery.

Presented here is a brief discussion on the imperative need and thoughtful approaches to embracing diversity, equity and inclusion within scientific enquiry.

SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy.

BACKGROUND: Confocal laser endomicroscopy (CLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces. By using intravenous or topical fluorescent agents, CLE highlights certain mucosal elements that facilitate an optical biopsy in real time. CLE technology has been used in different organ systems including the gastrointestinal tract. There has been numerous studies evaluating this technology in gastrointestinal endoscopy, our aim was to evaluate the safety, value, and efficacy of this technology in the gastrointestinal tract. METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) performed a PubMed/Medline database search of clinical studies involving CLE in May of 2018. The literature search used combinations of the keywords: confocal laser endomicroscopy, pCLE, Cellvizio, in vivo microscopy, optical histology, advanced endoscopic imaging, and optical diagnosis. Bibliographies of key references were searched for relevant studies not covered by the PubMed search. Case reports and small case series were excluded. The manufacturer's website was also used to identify key references. The United States Food and Drug Administration (U.S. FDA) Manufacturer And User facility and Device Experience (MAUDE) database was searched for reports regarding the device malfunction or injuries. RESULTS: The technology offers an excellent safety profile with rare adverse events related to the use of fluorescent agents. It has been shown to increase the detection of dysplastic Barrett's esophagus, gastric intraepithelial neoplasia/early gastric cancer, and dysplasia associated with inflammatory bowel disease when compared to standard screening protocols. It also aids in the differentiation and classification of colorectal polyps, indeterminate biliary strictures, and pancreatic cystic lesions. CONCLUSIONS: CLE has an excellent safety profile. CLE can increase the diagnostic accuracy in a number of gastrointestinal pathologies.

Biomarkers for Barrett's esophagus - a contemporary review.

INTRODUCTION: Esophageal adenocarcinoma (EAC) has a poor 5-year survival rate (10%-18%), and incidence has increased dramatically in the past three decades. Barrett's esophagus (BE) is the precursor lesion to EAC and is the replacement of the normally squamous lined esophagus with columnar cells that develop an intestinal phenotype characterized by the presence of goblet cells. Given the known precursor state, EAC is amenable to screening and surveillance strategies (analogous to colon cancer). However, unlike from colon cancer screening, BE poses challenges that make effective screening difficult. Robust and concerted effort is under way to find biomarkers of BE. Areas covered: This review summarizes current known biomarkers for BE. These include dysplasia, genomic markers, and gene expression alterations that occur early in the dysplasia/carcinoma sequence. Expert commentary: Despite the tremendous breadth of work in studying molecular advances, the ideal biomarker for BE has not yet been discerned. This review comments on innovations in the field of BE research that combine state-of-the-art molecular advances with simple technologies.

SAGES climate survey: results and strategic planning for our future.

BACKGROUND: While SAGES prides itself on diversity and inclusivity, we also recognize that as an organization we are not impervious to blind spots impacting equity within the membership. To address this, the We R Sages task force was formed to identify the barriers and facilitators to creating a diverse organization and develop a strategic plan for the implementation of programing and opportunities that promote diversity and inclusivity within our membership. As the first step in the process, a survey was administered to gauge the current organizational climate. METHODS: In September of 2017, a validated climate survey was administered to 704 SAGES committee members via SurveyMonkey®. Climate was assessed on: overall SAGES experience, consideration of leaving the organization, mentorship within the organization, resources and opportunities within the organization, and attitudes and experiences within the organization. Additional free text responses were encouraged to generate qualitative themes. RESULTS: The survey response rate was 52.1% (n = 367). Respondent self-identified demographics were: male (73%), white (63%), heterosexual (95.5%), and non-disabled (98%). Average overall satisfaction was 8.1/10. 12.5% of respondents had considered leaving the organization and 74.4% had not identified a formal mentor within the organization. Average agreement with equitable distribution of resources and opportunities was 5.8/10. 93.6% of respondents had not experienced bias within the organization. CONCLUSION: Overall SAGES has a very positive climate; however, several key issues were identified from the quantitative survey as well as the free text responses. Strategic planning to address issues of membership recruitment, committee engagement, advancement transparency, diversity awareness, leadership development, and formal mentorship are being implemented.

Panomics for Precision Medicine.

Medicine is poised to undergo a digital transformation. High-throughput platforms are creating terabytes of genomic, transcriptomic, proteomic, and metabolomic data. The challenge is to interpret these data in a meaningful manner - to uncover relationships that are not readily apparent between molecular profiles and states of health or disease. This will require the development of novel data pipelines and computational tools. The combined analysis of multi-dimensional data is referred to as 'panomics'. The ultimate hope of integrative panomics is that it will lead to the discovery and application of novel markers and targeted therapeutics that drive forward a new era of 'precision medicine' where inter-individual variation is accounted for in the treatment of patients.

Feasibility, safety, and short-term efficacy of the laparoscopic Nissen-Hill hybrid repair.

BACKGROUND: A novel antireflux procedure combining laparoscopic Nissen fundoplication and Hill repair components was tested in 50 patients with paraesophageal hernia (PEH) and/or Barrett's esophagus (BE) because these two groups have been found to have a high rate of recurrence with conventional repairs. METHODS: Patients with symptomatic PEH and/or non-dysplastic BE underwent repair. Quality of life (QOL) metrics, manometry, EGD, and pH testing were administered pre- and postoperatively. RESULTS: Fifty patients underwent repair. There was no mortality and four major complications. At 13-month follow-up, there was one (2%) clinical recurrence, and two (4%) asymptomatic fundus herniations. Mean DeMeester scores improved from 57.2 to 7.7 (p < 0.0001). Control of preoperative symptoms was achieved in 90% with 6% resumption of antisecretory medication. All QOL metrics improved significantly. CONCLUSIONS: The hybrid Nissen-Hill repair for patients with PEH and BE appears safe and clinically effective at short-term follow-up. It is hoped that the combined structural components may reduce the rate of recurrence compared to existing repairs.

SAGES research agenda in gastrointestinal and endoscopic surgery: updated results of a Delphi study.

BACKGROUND: Research in gastrointestinal and endoscopic surgery has witnessed unprecedented growth since the introduction of minimally invasive techniques in surgery. Coordination and focus of research efforts could further advance this rapidly expanding field. The objective of this study was to update the SAGES research agenda for gastrointestinal and endoscopic surgery. METHODS: A modified Delphi methodology was used to create the research agenda. Using an iterative, anonymous web-based survey, the general membership and leadership of SAGES were asked for input over three rounds. Initially submitted research questions were reviewed and consolidated by an expert panel and redistributed to the membership for priority ranking using a 5-point Likert scale of importance. The top 40 research questions of this round were then redistributed to and re-rated by members, and a final ranking was established. Comparisons were made between membership and leadership responses. RESULTS: 283 initially submitted research questions were condensed into 89 distinct questions, which were rated by 388 respondents to determine the top 40 questions. 460 respondents established the final ranking of these 40 most important research questions. Topics represented included training and technique, gastrointestinal, hernia, GERD, bariatric surgery, and endoscopy. The top question was, "How do we best train, assess, and maintain proficiency of surgeons and surgical trainees in flexible endoscopy, laparoscopy, and open surgery?" 28% of responders were leadership and the rest general members with the majority of ratings (73%) being similar between the groups. While SAGES leadership rated the majority of questions (89%) lower, they rated nonclinical questions higher compared with general membership. CONCLUSIONS: An updated research agenda for gastrointestinal and endoscopic surgery was developed using a systematic methodology. This agenda may assist investigators and funding organizations to concentrate their efforts in the highest research priority areas and editors and reviewers in assessing the merit and relevance of scientific work.

The laparoscopic Nissen-Hill hybrid: pilot study of a combined antireflux procedure.

BACKGROUND: Laparoscopic antireflux surgery is highly effective in patients with uncomplicated gastroesophageal reflux disease (GERD). However, long-term failure rates in paraesophageal hernia (PEH) and Barrett's metaplasia (BE) are higher and warrant a more durable repair. Outcomes for the laparoscopic Nissen fundoplication (LNF) and Hill repair (LHR) are equivalent, but their anatomic components are different and may complement each other (Aye R Ann Thorac Surg, 2012). We designed and tested the feasibility and safety of an operation that combines the essential components of each repair. METHODS: A prospective, phase II pilot study was performed on patients with symptomatic giant PEH hernias and/or GERD with nondysplastic Barrett's metaplasia. Pre- and postoperative esophagogastroduodenoscopy (EGD), upper gastrointestinal study (UGI), 48-hour pH testing, manometry, and three quality-of-life metrics were obtained. RESULTS: Twenty-four patients were enrolled in the study. Three patients did not complete the planned procedure, leaving 21 patients, including 12 with PEH, 7 with BE, and 2 with both. There were no 30-day or in-hospital mortalities. At a median follow-up of 13 (range 6.4-30.2) months, there were no reoperations or clinical recurrences. Two patients required postoperative dilation for dysphagia, with complete resolution. Mean DeMeester scores improved from 54.3 to 7.5 (p < 0.0036). Mean lower esophageal sphincter pressures (LESP) increased from 8.9 to 21.3 mmHg (p < 0.013). Mean short-term and long-term QOLRAD scores improved from 4.09 at baseline to 6.04 and 6.48 (p < 0.0001). Mean short-term and long-term GERD-HQRL scores improved from 22.9 to 7.5 and 6.9 (p < 0.03). Mean long-term Dysphagia Severity Score Index improved from 33.3 to 40.6 (p < 0.064). CONCLUSIONS: The combination of a Nissen plus Hill hybrid reconstruction of the gastroesophageal junction (GEJ) is technically feasible, safe, and not associated with increased side effects. Short-term clinical results in PEH and BE suggest that this may be an effective repair, supporting the value of further study.

MIS training in Canada: a national survey of general surgery residents.

BACKGROUND: General surgery trainees' perceptions regarding their own laparoscopic training remain poorly defined. The objective of this survey was to identify and evaluate learner experiences with laparoscopic procedures in general surgery programs on a national level. METHODS: Two hundred eighty-four residents were identified and contacted at English-speaking general surgery programs across Canada. Each was asked to complete a web- or paper-based survey regarding their demographics, experiences with basic and advanced minimally invasive surgery (MIS) procedures, and perceived barriers to training. RESULTS: Two hundred fifty-two of 284 (89%) surveyed residents responded. Eighty-seven percent of the residents had access to a skills lab that taught MIS techniques; however, standardized MIS curricula were implemented 53% of the time. Eighty percent of residents felt that skills lab training translated to improved performance in the OR. Although 90% of residents felt that they would be comfortable performing basic laparoscopic procedures, only 8% stated they would be comfortable performing advanced procedures at the end of their training. Moreover, 90% of general surgery residents felt that it was the academic surgical department's responsibility to teach both basic and advanced procedures, and 35% of respondents felt their surgical program was meeting this requirement. Half of the residents felt they had limited opportunity to be a primary surgeon because an MIS fellow was present. CONCLUSIONS: There exists a wide disparity between the expectations of residents and their actual experience. The majority of residents are concerned that they will not acquire sufficient laparoscopic skills during their training to perform advanced cases in practice. Additionally, the balance between resident and fellow-level cases needs to be more clearly defined as the majority of respondents identified the presence of a MIS fellow as a negative learning influence. Finally, although most centers had a surgical skills lab, 47% of respondents felt that the curriculum was not standardized and this also needs to be addressed.

A descriptive analysis of gastric cancer specimen processing techniques.

BACKGROUND: Adherence to guidelines for adequate gastric cancer specimen assessment is poor in North America. Inadequate staging and poor prognosis were noted in some series when these guidelines are not met. Recent advances have been made in standardizing cancer pathology reports in Canada; however, the uptake of these reporting systems is unknown for gastric cancer. A survey of pathologists in Ontario was performed to outline the processing techniques and practices for assessing gastric cancer specimens. METHODS: A survey was designed through a collaboration of surgical oncologists, general surgeons, pathologists, and research staff. Pathologists were identified using the College of Physicians and Surgeons of Ontario and MD Select databases. Participants were surveyed online or by mail-out. RESULTS: The response rate was 40.2% (147/366). Vascular invasion, perineural invasion, and signet ring cells were all reported as being examined for by the majority of pathologists. Fat clearing solution and keratin immunohistochemical techniques were not reported as being consistently utilized. Less than 70% of pathologists indicated using a form of synoptic report. CONCLUSION: Variations in practice and technique were observed. This may or may not reflect differences in quality of care or simply preferences for achieving equivalent results in the absence of standardized procedures. Education, evidence-based procedural guidelines and further research are required to provide infrastructure and support for pathologists and surgeons involved in the care of gastric cancer patients.

Improving the quality of processing gastric cancer specimens: the pathologist's perspective.

BACKGROUND AND OBJECTIVES: Research into surgeon and pathologist knowledge of guidelines for lymph node (LN) assessment in gastric cancer demonstrated a knowledge deficit. To understand factors affecting optimal assessment we surveyed pathologists to identify external barriers. METHODS: Pathologists were identified using two Ontario physician databases and surveyed online or by mail, with a 40% response rate. RESULTS: The majority (56%) of pathologists stated assessing an additional five LNs would not be a burden. Most (80%) pathologists disagreed with pay for performance for achieving quality standards. Qualitative analysis determined the majority of pathologists believed achieving quality standards was inherent to their profession and should not require incentives. Poor surgical specimen was identified as a barrier and underscores the importance of aiming quality improvement initiatives at the multidisciplinary team. CONCLUSION: In addition to education, tailoring an intervention to address all barriers, including laboratory constraints may be an effective means of improving gastric cancer care.

Quality indicators for gastric cancer surgery: a survey of practicing pathologists in Ontario.

BACKGROUND: Adequate lymph node (LN) assessment and R0 resection are critical to the staging and management of gastric cancer. The American Joint Committee on Cancer/International Union Against Cancer recommend at least 15 LN be assessed, and the literature suggests a gross disease-free margin of 5-6 cm be achieved. Results of an Ontario general surgeons' survey indicated these standards were not widely known. Because disease management is highly collaborative, we surveyed pathologists to assess their knowledge of LN assessment and margins for processing gastric cancer specimens. METHODS: Pathologists were identified by the College of Physicians and Surgeons of Ontario and MD Select databases. Participants were surveyed online or by mail. RESULTS: Pathologists indicated a goal of assessing <5 LN (2%), 5-10 LN (27%), 10-15 LN (40%), 15-20 LN (20%), or >20 LN (11%). Most self-reported an actual assessment of 5-10 LN (49%), with 88% reporting a number below current standards. Additionally, 54% of responding pathologists identified >1 cm as an adequate gross margin, and 89% of pathologists indicated a response below current standards. Ninety-four percent of pathologists agreed that more education on gastric cancer is valuable. CONCLUSIONS: To improve the quality of gastric cancer management, our findings suggest the need for clear, consistent guidelines for adequate gross margin resection length. Furthermore, there is a critical need for education aimed at closing the knowledge gap among practicing pathologists and surgeons regarding current recommended guidelines for LN assessment and adequate margin length.