Mirjam Kaijser

? ! Mirjam Anna Kaijser TEACHING AND LEARNING METABOLIC BARIATRIC SURGERY

Teaching and learning metabolic bariatric surgery Mirjam Anna Kaijser

Ó Copyright 2024 M.A. Kaijser, The Netherlands Teaching and learning metabolic bariatric surgery Thesis, University of Groningen, the Netherlands Printing: Ridderprint | www.ridderprint.nl Cover design: Joey Roberts Sponsors: The printing of this thesis was kindly supported by the Dutch Society for Metabolic and Bariatric Surgery All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form without the written permission of the author.

Teaching and learning metabolic bariatric surgery Proefschrift ter verkrijging van de graad van doctor aan de Rijksuniversiteit Groningen op gezag van de rector magnificus prof. dr. ir. J.M.A. Scherpen en volgens besluit van het College voor Promoties. De openbare verdediging zal plaatsvinden op woensdag 27 november 2024 om 14.30 uur door Mirjam Anna Kaijser geboren op 16 juli 1984

Promotores Prof. dr. J.P.E.N. Pierie Prof. dr. G.H. van Ramshorst Prof. dr. B.A. van Wagensveld Beoordelingscommissie Prof. dr. M.J.E. Mourits Prof. dr. H.A. Cense Prof. dr. E.J. Hazebroek

TABLE OF CONTENTS Chapter 1 General introduction and outline of this thesis 7 PART 1 Current Training Practice Chapter 2 Current techniques of teaching and learning in bariatric surgical procedures: a systematic review Journal of Surgical Education - 2018 23 Chapter 3 Resident training in bariatric surgery – a national survey in the Netherlands Obesity Surgery – 2017 43 PART 2 Training and Assessment Chapter 4 A Delphi consensus of the crucial steps in gastric bypass and sleeve gastrectomy procedures in the Netherlands Obesity Surgery - 2018 61 Chapter 5 A new procedure-based assessment of operative skills in gastric bypass surgery, evaluated by video fragment rating Obesity Surgery – 2024 81 PART 3 Skills Training Chapter 6 Laparoscopic small bowel length measurement in bariatric surgery using a hand-over-hand technique with marked graspers: an ex vivo experiment Obesity Surgery – 2022 113 Chapter 7 Measuring small bowel length in bariatric surgery: an ex vivo laparoscopic training experiment Surgical Innovation - 2024 131 Chapter 8 General discussion and future perspectives 147 Chapter 9 English summary Nederlandse samenvatting 173 Appendices Appendix A-F Dankwoord Curriculum Vitae List of Publications List of Abbreviations 184 194 197 198 199

CHAPTER 1 General introduction and outline of this thesis General introduction and outline of this thesis CHAPTER 1

METABOLIC BARIATRIC SURGERY The World Health Organization (WHO) declared obesity as a global pandemic in 1997.1 This disease affects over 650 million people worldwide, 13% of the adult population. This number is expected to grow to 1 billion in 2030.2 Obesity is defined as an excess amount of adipose tissue, associated with health risks including type 2 diabetes, hypertension, high serum cholesterol, cardiovascular disease, musculoskeletal disorders, sleep apnea, and cancer.3 These weight related health risks are related to the Body Mass Index (BMI), calculated as weight (kg)/height (m)2 (Table 1). The origin of obesity in an individual is multifactorial, including genetic, biological, mental health, sociocultural and economic factors, food consumption and energy expenditure.4 Living with obesity, a chronic illness, negatively impacts the disease adjusted life-years (DALY) and may lead to preliminary death.2 Table 1: Classification of Obesity and Prevalence in the Netherlands in 2022 BMI (kg/m2) Classifica2on Health Risk 5 Prevalence (%) 6 < 18.5 Underweight Increased 1.9 18.5-25 Normal weight Normal 47.9 25-30 Overweight Increased 35.1 > 30 30-35 35-40 > 40 > 50 > 60 Obesity Obesity Class I Obesity Class II Obesity Class III Obesity Class IV Obesity Class V High Very high Extremely high “ “ 15.1 10.8 3.0 1.3 BMI = Body Mass Index Prevention of obesity is the ultimate remedy. Globally, preventive measures are being taken focusing on counteracting factors as high calorie food consumption and reduced exercise. Treatment of obesity is aimed to reduce the burden of the disease, improve associated diseases and quality of life, and increase life expectancy. For individual patients living with obesity the cornerstones of treatment are lifestyle interventions, including dietary restrictions and exercise programs, sometimes accompanied by coaching or psychological treatment. As these lifestyle interventions alone often fail to induce and sustain significant weight loss, other treatment options include pharmacological therapy or surgery.7 This specific type of surgery is called bariatric surgery, weight loss surgery or metabolic surgery, often combined into 8 1

‘metabolic bariatric surgery’ (MBS). The word bariatric is derived from the Greek βάρος (baros) meaning heaviness or weight, with ἰατρός (iatros) referring to treatment or doctor. Surgery aimed at weight loss has been performed since the 1960s, but has proliferated since the introduction of laparoscopic techniques in 1994, when Alan Wittgrove performed the first laparoscopic Roux-en-Y gastric bypass (LRYGB).8 Surgical databases of the International Federation for Surgery for Obesity and Metabolic disorders (IFSO) and the Dutch Audit for the Treatment of Obesity (DATO) contain records of 189,719 bariatric cases worldwide in 2018, of which 11,494 in the Netherlands.9,10 The most common bariatric procedures are the Roux-enY gastric bypass (RYGB) and the sleeve gastrectomy (SG) (Figure 1).9 Other MBS procedures include the one-anastomosis gastric bypass (OAGB), and the adjustable gastric band (AGB). Figure 1: Metabolic Bariatric Procedures Worldwide, in Western Europe and the Netherlands in 2022 AGB = Adjustable Gastric Band, OAGB = One-Anastomosis gastric bypass, RYGB = Roux-en-Y gastric bypass, SG = Sleeve Gastrectomy Data derived from the 2018 registries of the International Federation for Surgery for Obesity and Metabolic disorders (IFSO) and the Dutch Audit for the Treatment of Obesity (DATO).9,10 International consensus guidelines advise to use MBS as a treatment option when a patients BMI exceeds 40 kg/m2, or 35 kg/m2 and is accompanied by associated diseases such as sleep apnea, hypertension, and non-alcoholic fatty liver disease.11 However, the most recent statement of the American Society for Metabolic & Bariatric Surgery (ASMBS) recommends MBS for patients with a BMI > 35 kg/m2 regardless of associated diseases, and for patients 1 9 General introduction and outline of this thesis

with type 2 diabetes and a BMI > 30 kg/m2.12 These thresholds have also been advocated for in the Dutch guidelines on the surgical treatment of obesity.13 In 2022, 50.2% of the Dutch population classified as overweight and 15.1% had obesity (Table 1).6 If desired by the patient and deemed feasible by a team of licensed health care professionals, MBS can be presented as a treatment option. In the Netherlands, 10,000 - 12,000 MBS procedures are performed in 18 metabolic bariatric centres each year.10 The effects of these procedures are a combination of restricted food intake, an altered absorption of macro- and micronutrients, combined with more complex mechanisms such as the alteration in gut hormones signalling hunger and appetite, changes in gut microbiome, bile acids and brain function, including changes in reward systems.14–16 Surgical Technique Although both the RYGB and SG are used extensively, the surgical technique varies amongst countries, centres, and individual surgeons. Attempts have been made to both standardize the components of these procedures, as well as the execution.17 The use of a laparoscopic technique instead of an open approach has been considered the standard in MBS. The RYGB, as a treatment option for obesity, was introduced by Mason in 1966. It consists of a gastric pouch, which is connected to the small bowel with a Roux-en-Y reconstruction, bypassing the duodenum and first part of the jejunum.8 After technical modifications with a much smaller gastric pouch and variations in limb length, the ‘standard’ RYGB now consists of a 30 ml pouch, a 50-150 cm biliopancreatic limb (BPL) connected to this pouch, a 50-150 cm alimentary limb (AL) which in turn connects to the BPL and continue together as the common channel (CC) (Figure 2).17 Many variations exist of the anastomosis between the pouch and BPL, the gastrojejunostomy, with for instance a circular stapled, a linear stapled and a handsewn technique. In the Netherlands the use of an antegastric antecolic linear stapled gastrojejunostomy, is the most used technique.18 The SG (Figure 3) was historically used as the first step of a RYGB or biliopancreatic diversion/duodenal switch (BPD/DS) and has been in use as a stand-alone operation from the year 2000 onwards. The vertical transection of the stomach is started 2-6 cm proximal of the pylorus at the greater curvature and continued upwards to 1-2 cm lateral of the esophageal gastric junction. This leaves a 2.5-3 cm wide tube, with a volume of 75-150 ml. The lateral remainder is resected.17 10 1

Figure 2: Roux-en-Y Gastric Bypass 19 In the Roux-en-Y gastric bypass a 30 ml stomach pouch is separated from the remainder. This pouch is connected to the small bowel, transsected at 50-150 cm after Treitz’ ligament. A second anastomosis connects the hereby created biliopancreatic limb (BPL) to the alimentary limb (AL) and remaining common channel (CC) of the small bowel. The large intestine is left unaltered. Figure 3: Sleeve Gastrectomy 19 The sleeve gastrectomy creates a 75-150 ml tube-shaped stomach, after transacting the stomach in a longitudinal fashion. The remaining 80% of the stomach is removed after dissecting this from the greater omentum. The small bowel and large intestine are not altered in this procedure. 1 11 General introduction and outline of this thesis

SKILLS ACQUISITION IN SURGERY – TRAINING AND ASSESSMENT Surgical Curriculum The Dutch Surgical resident curriculum ‘SCHERP’ is a six-year competency-based program with defined learning goals or attainment levels. The first four years are a ‘general residency’ program with rotations in different subspecialties. Postgraduate year (PGY) 5 and 6 of the Dutch surgical curriculum consist of a differentiation in vascular-, paediatric-, trauma-, oncological- or gastrointestinal surgery.20 Next to the entrustable professional activities (EPAs), that can contain specific non-technical skills and knowledge as well as operative procedures, the professional development of residents is monitored by instruments as short clinical assessments and 360-degree feedback, aimed at development in all CANMEDS domains (Figure 4).21 Figure 4: Dutch Surgical Curriculum EPA = entrustable professional activity, PGY = postgraduate year Technical skills are historically trained by a master-apprentice model in which the role of the resident gradually evolves from assistant to first surgeon. With more strict regulations of workhours and administrative obligations, the time spent in the operating theatre, however, is restricted. In the American ACGME residency program working hours are regulated tot 6080 work hours per week. This regulation of the workhours leads to a decrease in operative case load during training.22 In the Dutch collective employment agreement in the medical sector the working hour maximum is even lower with a maximum of 48 hours, including 10 12 1

hours dedicated to educational purposes.23 This urges a time-balanced and goal-directed resident training curriculum. Technical Training Technical training – mastering surgical procedures - has different aspects: the trainee must learn WHY they must perform an operative step; WHAT steps are needed to accomplish this and HOW these steps are executed technically. The technical training includes procedural knowledge, i.e. the knowledge of the techniques available, psychomotor, or manual skills, and the ability to handle unexpected situations. These skills are obtained by observational learning, technical discussions, simulation training and obtaining hands-on experience.24 A major part of surgical training takes place in the operating theatre. Participation of general surgical residents or fellows may lead to a higher complication rate, mainly due to prolonged operation times.25 The effect of training in the operating theatre on patient safety should therefore be monitored. Patient safety is not an issue in surgical simulation, which is used throughout training of residents, fellows, and surgeons. Simulation training includes the use of animal and synthetic models, augmented- and virtual reality, box-training and human cadavers. This type of training can be both used to obtain specific procedural skills and to prevent decay of skills in time.26,27 Assessment A crucial point in learning is guided training, feedback, and assessment. Although in Dutch history the Amsterdam Surgeons’ Guild (1461-1736) finalized surgical training with a master’s exam, in current practice surgical training is completed after a set time, provided the learning goals are met and the EPAs are entrusted.28 During progression to an EPA, formative, not summative, assessments are used to support feedback as well as prove of skill. Formative assessments are usually designed for low-stake assessments, to support the training process, and feedback. Summative assessments, like exams, are usually used in high-stakes situations, for example credentialing of specific privileges. Entrustment of professional activities, including a check of all necessary formative assessments, can therefore be seen as summative assessments. For technical training the standard assessment in the Dutch curriculum is the Objective Structured Assessment of Technical Skill (OSATS) introduced by Martin et al..29 The standard OSATS uses a Global Rating Scale (GRS). A modified version was introduced in the Netherlands 1 13 General introduction and outline of this thesis

around 2012 and implemented in the residents’ portfolio.30 In this version of the OSATS, the GRS is combined with an Overall Performance Scale (OPS) and Alphabetic Summary Scale (ASS). An example is found in Appendix A of this thesis. In laparoscopic training next to the OSATS the Global Operative Assessment of Laparoscopic Skills (GOALS) is used in the Netherlands. Both OSATS and GOALS are generic assessment, they do not focus on specific surgical tasks or procedures. The validity of these GRS in grading or granting privileges is uncertain, as is their role in fellowship training.31 With curricula based on EPAs it is important to support entrustment with well-grounded, valid, assessments. Lifelong Learning After successful completion of general surgical training, the trainee is certified as a surgeon. However, training does not stop there. It is an ongoing process throughout the whole surgical career. Some surgical procedures are, due to their complexity or relatively low prevalence, part of an additional fellowship training program, often less formally described than the resident programs. Moreover, as new operative techniques will emerge throughout any surgical career, the ability to update skills and innovate techniques is an essential part of lifelong learning. METABOLIC BARIATRIC SURGERY TRAINING When new techniques or procedures are added to the surgical armamentarium, history shows that firstly the surgeons, and next the trainees adapt this new technique. After the introduction of laparoscopic surgery in the Netherlands, for example, minimally invasive surgery fellowships -as the LIMIS program-, were introduced to teach this novelty to attending surgeons.32 Nowadays, these laparoscopic techniques are adopted by residents from the first days of training practice. Residency programs include laparoscopic training courses such as the Fundamentals of Laparoscopic Surgery (FLS) program in the United States and specific courses in the Dutch curriculum.20,33 In 2015 Mostaedi et al. published an evaluation of the procedures in the Faculty Practice Solution Center (FPCS) database of the University Health System Consortium and Association of American Medical Colleges.34 In the most performed procedures in general surgical practice in 2006-2011 the laparoscopic RYGB (LRYGB) consistently ranked top 10, representing 18.2 - 24.6% of all cases. A more recent review of Jog et al. shows MBS fellows in the US performed 14 1

a mean number of 52.6 LRYGB and 60.7 laparoscopic SG (LSG) cases in 2018-2019, which are low numbers compared to the learning curve of these procedures.35 This calls for further integration of MBS the general surgery curriculum to ensure adequate skill acquisition to perform advanced laparoscopic surgery and deal with complications of these procedures. With a yearly total of 10,000 - 12,000 procedures in the Netherlands, MBS is a rapidly evolving part of gastrointestinal surgery and therefore claiming its place in the surgical training programs (Figure 5). In the Netherlands, MBS is an optional module in the gastrointestinal differentiation program. The goal of this module is to obtain knowledge about the screening, pre- and postoperative care and follow up of the metabolic bariatric patient and to master the LSG and LRYGB at a completely independent level.20 If these goals are not obtained during the residency, metabolic bariatric fellowship programs are available to obtain these skills. This MBS training module in the SCHERP curriculum results in the EPA MBS, presented in Appendix B of this thesis. Figure 5: Role of MBS in the Extended Surgical Curriculum EPA = entrustable professional activity, MBS = metabolic bariatric surgery, PGY = postgraduate year As MBS is incorporated in the fellow- and resident training programs a more specified curriculum may target the learning curve of both general technical skills and specific procedures. This curriculum should be supported by assessment that are both summative and formative, to provide feedback during training and formalize the EPA in MBS. 1 15 General introduction and outline of this thesis

GENERAL AIM AND OUTLINE OF THIS THESIS This thesis aims to lay the fundament of a laparoscopic metabolic bariatric surgery training program, including assessment and credentialing tools. PART 1 - Current Training Practice The first part of this thesis focusses on the current national and international practice in teaching bariatric surgery. Chapter 2 provides an overview of the available international literature in this field. The review includes research on teaching, assessment and learning of the LRYGB and LSG. It entails the training of both residents and fellows. A systematic review of the available literature demonstrates a heterogeneous range of teaching techniques, and therefore gives a broad fundament of available tools including pre-theatre ex-vivo training - either virtual reality, box training or surgical models – and post theatre surgical coaching. Adopting a stepwise approach of teaching and learning MBS procedures, an overview of the current national practice is established in Chapter 3. Most teaching hospitals in the Netherlands that perform MBS have adopted some sort of stepwise education and instruct the procedural steps either in a chronological order or in the order of complexity of the steps.36,37 Residents in these MBS training programs are expected to have basic laparoscopic skills training, and some experience with less complex laparoscopic procedures. The main questions to be answered in this chapter is WHERE to start and WHEN to start training these procedures. PART 2 - Training and Assessment The second part of this thesis focusses on WHAT we are teaching. In the last decade, statements, and guidelines on the execution of metabolic bariatric procedures were published, supported by the national and international surgical associations such as the Dutch Society for Metabolic and Bariatric Surgery (DSMBS) and IFSO. Chapter 4 presents the results of a consensus amongst Dutch expert bariatric surgeons on which key steps of the LSG and LRYGB should be the focus of both training and assessment. In previous studies, including non-bariatric procedures, such a consensus, attained with the Delphi method, resulted in a framework of surgical key steps for training and assessment. 16 1

Subsequently, Chapter 5 describes the first use of an independence scaled procedure-based assessment in video fragments of the LRYGB. A procedure-based assessment (PBA) can be used both as a formative feedback tool in the learning process, and as a summative assessment in credentialing residents and surgeons for specific procedures. PART 3 - Technical Training In the final part of this thesis, a specific technical step of the LRYGB is discussed: running of the small bowel and determining its length. Determining limb length is arguably an important component of the outcomes of gastric bypass surgery and thus should be performed within an acceptable range. To establish HOW we should train and assess trainees to perform this part of the procedure, this step was transferred to an ex vivo setting to allow repeated measurements. Chapter 6 describes a cross-sectional study of the performance of the bariatric surgical staff and surgical residents on their accuracy in this step. The goal of the study is to investigate whether residents and surgeons perform differently on this task. In Chapter 7 a laparoscopic training box exercise on a rope is used to train residents in this same step of determining small bowel limb length. This study aims to determine if ex vivo box training improves the accuracy of small bowel length determination before residents execute this step as part of a procedure in the operating theatre. Chapter 8 provides a general discussion and reflects on how the results of this research could improve bariatric surgical training and builds towards a bariatric surgical training curriculum. This thesis is summarized in Chapter 9. 1 17 General introduction and outline of this thesis

REFERENCES 1. James WP. WHO recognition of the global obesity epidemic. Int J Obes. 2008;32 Suppl 7:S120S126. 2. World Obesity Federation. World Obesity Atlas 2022 [Internet]. Accessed February 1, 2024. https://www.worldobesityday.org/assets/downloads/World_Obesity_Atlas_2022_WEB.pdf 3. Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894(i-xii,):1-253. 4. Busebee B, Ghusn W, Cifuentes L, Acosta A. Obesity: A Review of Pathophysiology and Classification. Mayo Clin Proc. 2023;98(12):1842-1857. 5. Health Canada. Body Mass Index (BMI) Nomogram [Internet]. Accessed February 1, 2024. https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/healthyweights/canadian-guidelines-body-weight-classification-adults/body-mass-index-nomogram.html 6. Kloosterman R, Akkermans M, Reep C, Tummers – van der Aa M. [(On)gezonde leefstijl 2022: opvattingen, motieven en gedragingen.] 2023 [Internet]. Accessed February 1, 2024. https://www.cbs.nl/nl-nl/longread/rapportages/2023/on--gezonde-leefstijl-2022-opvattingenmotieven-en-gedragingen/5-afvallen 7. NHLBI. Managing Overweight and Obesity in Adults: Systematic Evidence Review from the Obesity Expert Panel. 2013. 8. Faria GR. A brief history of bariatric surgery. Porto Biomed J. 2017;2(3):90-92. 9. Welbourn R, Hollyman M, Kinsman R, et al. Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Fourth IFSO Global Registry Report 2018. Obes Surg. 2019;29(3):782-795. 10. DATO Dutch Audit for Treatment of Obesity. DATO 2015-2019. Published 2019 [Internet]. Accessed February 1, 2024. https://dica.nl/jaarrapportage-2019/dato 11. Fried M, Yumuk V, Oppert JM, et al. Interdisciplinary European guidelines on metabolic and bariatric surgery. Obes Surg. 2014;24(1):42-55. 12. Eisenberg D, Shikora SA, Aarts E, et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022;18(12):1345-1356. 13. Nederlandse Vereniging voor Heelkunde. [Chirurgische behandeling van obesitas]. Federatie Medisch Specialisten. Published online 2020:252. Accessed February 1, 2024. https://richtlijnendatabase.nl/richtlijn/chirurgische_behandeling_van_obesitas/indicatiestelling_ bij_chirurgische_behandeling_van_obesitas/algemene_indicatiestelling_bij_chirurgische_behand eling_van_obesitas.html 14. Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-yy levels after roux-en-y gastric bypass and sleeve gastrectomy a prospective, double blind study. Ann Surg. 2008;247(3):401407. 15. Pournaras DJ, Le Roux CW. Are bile acids the new gut hormones? Lessons from weight loss surgery models. Endocrinology. 2013;154(7):2255-2256. 16. Tremaroli V, Karlsson F, Werling M, et al. Roux-en-Y Gastric Bypass and Vertical Banded Gastroplasty Induce Long-Term Changes on the Human Gut Microbiome Contributing to Fat Mass Regulation. Cell Metab. 2015;22(2):228-238. 17. Bhandari M, Fobi MAL, Buchwald JN, et al. Standardization of Bariatric Metabolic Procedures: World Consensus Meeting Statement. Obes Surg. 2019;29:309-345. 18. Kaijser MA, van Ramshorst GH, Emous M, Veeger NJGM, van Wagensveld BA, Pierie JPEN. A Delphi Consensus of the Crucial Steps in Gastric Bypass and Sleeve Gastrectomy Procedures in the Netherlands. Obes Surg. 2018;28(9):2634-2643. 18 1

19. Steenackers N, Vanuytsel T, Augustijns P, et al. Adaptations in gastrointestinal physiology after sleeve gastrectomy and Roux-en-Y gastric bypass. Lancet Gastroenterol Hepatol. 2021;6(3):225237. 20. Concillium Chirurgicum. [Landelijk Opleidingsplan SCHERP 2.1.] Published 2021. Accessed February 1, 2024. https://www.heelkunde.nl/themas/thema?dossierid=32768000&title=SCHERP 21. Frank JR, Danoff D. The CanMEDS initiative: implementing an outcomes-based framework of physician competencies. Med Teach. 2007;29(7):642-647. 22. Blencowe NS, Parsons BA, Hollowood AD. Effects of changing work patterns on general surgical training over the last decade. Postgrad Med J. 2011;87(1034):795-799. 23. De Jonge Specialist. [Arbeidstijden voor aios en anios]. Published 2022 [Internet]. Accessed February 1, 2024. https://dejongespecialist.nl/wp-content/uploads/2020/10/brochurearbeidstijden-voor-aios-en-anios.pdf 24. Cnossen F. Cognitive Skill in Medicine: An Introduction. In P. Lanzer (Ed.), PanVascular Medicine (2nd ed., pp. 4719–4752). Springer. https://doi.org/10.1007/978-3-642-37393-0_181-1 25. Krell RW, Birkmeyer NJO, Reames BN, et al. Resident involvement and outcomes in bariatric surgery: a population-based study. J Am Coll Surg. 2013;217(3):S104. 26. Schlottmann F, Herbella FAM, Patti MG. Simulation for Foregut and Bariatric Surgery: Current Status and Future Directions. Journal of Laparoendoscopic and Advanced Surgical Techniques. 2021;31(5):546-550. 27. Higgins M, Madan C, Patel R. Development and decay of procedural skills in surgery: A systematic review of the effectiveness of simulation-based medical education interventions. Surgeon. 2021;19(4):e67-e77. 28. IJpma FFA, van de Graaf RC, Pierik EGJMR, van Gulik TM. [A master’s exam in surgical training]. Ned Tijdschr Geneeskd. 2010;154:A795. http://www.ncbi.nlm.nih.gov/pubmed/20178655 29. Martin JA, Regehr G, Reznick R, et al. Objective structured assessment of technical skill (OSATS) for surgical residents. British Journal of Surgery. 1997;84(2):273-278. 30. Hopmans CJ, Den Hoed PT, Van Der Laan L, et al. Assessment of surgery residents’ operative skills in the operating theatre using a modified Objective Structured Assessment of Technical Skills (OSATS): A prospective multicenter study. Surgery (United States). 2014;156(5):1078-1088. 31. van Hove PD, Tuijthof GJ, Verdaasdonk EG, Stassen LP, Dankelman J. Objective assessment of technical surgical skills. Br J Surg. 2010;97(7):972-987. 32. Bosker R, Groen H, Hoff C, et al. Effect of proctoring on implementation and results of elective laparoscopic colon surgery. Int J Colorectal Dis. 2011;26(7):941-947. 33. Fried GM. FLS assessment of competency using simulated laparoscopic tasks. J Gastrointest Surg. 2008;12(2):210-212. 34. Mostaedi R, Ali MR, Pierce JL, Scherer LA, Galante JM. Bariatric surgery and the changing current scope of general surgery practice: implications for general surgery residency training. JAMA Surg. 2015;150(2):144-151. 35. Jog A, Baldwin D, Wernsing D, et al. Trends in bariatric surgery training: bariatric operations performed by Fellowship Council trainees from 2012 to 2019. Surg Obes Relat Dis. 2024;20(6):545-552. 36. Iordens GI, Klaassen RA, van Lieshout EM, Cleffken BI, van der Harst E. How to train surgical residents to perform laparoscopic Roux-en-Y gastric bypass safely. World J Surg. 2012;36(9):20032010. 37. Walinga AB, van Mil SR, Biter LU, Dunkelgrün M, Vijgen GHEJ. A Stepwise Approach in Learning Surgical Residents a Roux-en-Y Gastric Bypass. Obes Surg. 2019;29(2):414-419. 1 19 General introduction and outline of this thesis

PART 1 Current training practice Current Training Practice PART 1

CHAPTER 2 Current techniques of teaching and learning in bariatric surgical procedures: a systematic review Mirjam Kaijser Gabrielle van Ramshorst Bart van Wagensveld Jean-Pierre Pierie Journal of Surgical Education - 2018 Current techniques of teaching and learning in bariatric surgical procedures: a systematic review Mirjam Kaijser, Gabrielle van Ramshorst, Bart van Wagensveld, Jean-Pierre Pierie Journal of Surgical Education - 2018 CHAPTER 2

ABSTRACT Objective: The sleeve gastrectomy and gastric bypass are the 2 most commonly performed metabolic bariatric procedures. This article provides an overview of current teaching and learning methods of those techniques in resident and fellow training. Design: A database search was performed on PubMed, Embase, and the Education Resources Information Center (ERIC) to identify the methods used to provide training in metabolic bariatric surgery worldwide. After exclusion based on titles and abstracts, full texts of the selected articles were assessed. Included articles were reviewed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Results: In total, 2442 titles were identified, and 14 full text articles met inclusion criteria. Four publications described an ex vivo training course, and 6 focused on at least 1 step of the gastric bypass procedure. Two randomized controlled trials (RCT) provided high-quality evidence on training aspects. Surgical coaching caused significant improvement of Bariatric Objective Structured Assessment of Technical Skill (BOSATS) scores (3.60 vs. 3.90, P = 0.017) and reduction of technical errors (18 vs. 10, P = 0.003). A preoperative warm-up increased global rating scales (GRS) scores on depth perception (P = 0.02), bimanual dexterity (P = 0.01), and efficiency of movements (P = 0.03). Conclusion: Stepwise education, surgical coaching, warming up, Internet-based knowledge modules, and ex vivo training courses are effective in relation to metabolic bariatric surgical training of residents and fellows, possibly shortening their learning curves. 24 2

INTRODUCTION Metabolic bariatric surgery (MBS) is a still increasing part of the general and gastrointestinal surgeons’ workload. Metabolic bariatric operations, and especially laparoscopic Roux-en-Y gastric bypass (LRYGB), are among the most frequently performed laparoscopic procedures.1 As the master-apprentice system is still fostered in resident- and fellow training, a significant number of the metabolic bariatric procedures are performed with trainees, either as assistants or as first surgeons. A national questionnaire in 251 surgical residency programs and 48 minimally invasive fellowship programs in the United States by Buchwald and Williams showed that in 185 of the 251 programs, metabolic bariatric surgery was performed, and 100% of cases were taught to residents.2 Numerous reports on the effects of fellow and resident participation in LRYGB are available in literature.3-7 Kim et al. reported benefits of fellowship programs for fellows, metabolic bariatric centres, and patient outcome.8 Negative effects, such as increased operating time, have also been reported.3,4 Steps have been made to incorporate MBS in the resident programs in several countries, including the United States, the bariatric curriculum of the Spanish Society of Bariatric Surgery and Metabolic Diseases (SECO), and the postgraduate Surgery for Obesity Registrar Training and Educational Development (SORTED) program in the United Kingdom.9,10 In the limited time span of surgical residency, as a result of current working hour regulations, advanced laparoscopic skills have to be mastered efficiently, without compromising patient safety.2 An email questionnaire among 132 residents and 59 faculty members performed by Gardner et al. shows that gaps exist in the technical competency of the residents, especially in advanced and laparoscopic cases.11 Mattar et al., describing that 80% of residents are pursuing an additional fellowship to enhance their training level, observed the same problem.12 However, they also describe a gap between the level of the finishing resident and the required level of starting fellows, both on technical and nontechnical aspects. These studies show that a critical appraisal of current teaching techniques could enhance future curriculum development. Among advanced laparoscopic procedures, metabolic bariatric surgery takes a special place because past research has focused on the learning curve of surgeons accustomed with open 2 25 Current techniques of teaching and learning in bariatric surgical procedures

metabolic bariatric procedures. Multiple combined preclinical and clinical training modules (i.e., weekend courses, mini fellowships) allowing metabolic bariatric surgeons to master the laparoscopic procedures are available.13 With most metabolic bariatric cases performed laparoscopically, residents and fellows have to learn these procedures without experience in open gastric bypass and sleeve operations. However, as these novice surgeons use laparoscopy from the start of their training, their laparoscopic learning curve may be shortened. Moreover, they can build on the pioneering work of previous surgeons, with a subsequent shorter learning curve.14,15 Although the learning curve for gastric bypass procedures has previously been suggested to lie between 50 and 150 procedures to reach a standard procedure time and complication rate, the learning curve for bariatric naïve novices such as residents and fellows has not been defined.4 Solid clinical training of residents and fellows can improve results and reduce learning curve related complications. Training may include physical model and virtual reality simulators, animal, and cadaver models, and also pre-, per- and postoperative guidance and instruction. A systematic review of Beyer-Berjot et al. on training in advanced abdominal laparoscopic surgery included 54 studies, but only 5 of those refer to bariatric surgery, of which 3 describe the laparoscopic adjustable gastric band and only 2 the LRYGB.16 Therefore, evidence on the training of the gastric bypass and sleeve gastrectomy is still lacking. This systematic review provides an overview of current teaching methods of the most common bariatric procedures, the laparoscopic Roux-en-Y gastric bypass (LRYGB) and sleeve gastrectomy (LSG), to residents and fellows. METHODS A systematic review was performed using medical databases PubMed-Medline, Embase, and the Education Resources Information Center (ERIC). Searches were dated November 1, 2015. A broad search was performed in PubMed and Embase using the Mesh terms Bariatric Surgery, Medical Education and Learning, and related text words. For ERIC, the keywords “bariatric surgery,” “gastric bypass,” and “gastric sleeve” were used. Duplicates were removed by matching titles and authors. 26 2

Exclusion Criteria By means of a predefined list titles referring to robotic surgery, laparo-endoscopic single-site surgery (LESS) or single incision laparoscopic surgery (SILS), biliopancreatic diversion and laparoscopic adjustable gastric banding were excluded. Studies focusing on obesity-related comorbidity such as obstructive sleep apnea, hernia, and pancreatitis, and other subjects not related to primary metabolic bariatric surgery such as dermatology and cosmetic and plastic surgery were also eliminated. As the search criteria included “training” and “exercise,” studies focusing on patient training and patient exercise, diet and nutrition were removed. Inclusion Criteria Two independent reviewers (M.A.K. and G.H.v.R.) independently selected titles. Only abstracts describing resident or fellow learning were selected, excluding studies solely describing learning curves or education of fully trained surgeons. Next, full-text peer-reviewed articles were included if selected by one or both reviewers. Both reviewers fully and independently assessed the selected full texts. In case of disagreement, articles were discussed until consensus was reached. Data Extraction The final selection was analysed for type of procedure, laparoscopic experience, education level, and types of tests. Outcomes included operation times and complications. Study quality was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.17 RESULTS Article Selection In total, 2442 titles were identified in the search; 388 duplicates were removed. Based on previously described exclusion criteria, 486 titles were excluded, and another 1292 were considered irrelevant. Sixty-two of 276 remaining titles were selected based on abstract. Eighteen of those were not published as a full-text peer-reviewed article. Fourteen out of these 44 articles were included in this systematic review after full text assessment. The selection process is displayed in Figure 1. 2 27 Current techniques of teaching and learning in bariatric surgical procedures

Level of Evidence Two randomized controlled studies, 1 systematic review, 9 cohort or retrospective series, and 2 surveys were included (Table 1). Study populations varied between 5 and 272 subjects. Eight of 14 studies focused on residents only, others also included fellows or surgeons. Most studies concentrated on LRYGB procedures; 3 studies included the LSG. One study of Azer et al. solely focused on knowledge acquisition of surgical residents on the topic of metabolic bariatric surgery through an online platform.18 Four publications (28%) described an ex vivo training course for residents and surgeons.19-22 Three authors (21%) divided the gastric bypass procedure into 3 steps (creating the pouch, gastrojejunostomy, and jejunojejunostomy) and taught residents 1 step at a time.6,23,24 Three other studies described the education of a single step only (jejunojejunostomy) or aimed their study at training of a single step.20,25,26 Figure 1: PRISMA Flow Diagram of Selection Process ERIC = Education Resources Information Center 28 2

Table 1: GRADE Assessment of Included Studies Study Year of publica2on Type of trial Region N. of par2cipants N. of procedures GRADE Up- or down grading Reason for adjustment Azer et al.18 2013 Cohort USA 12 - Very low Downgrade High risk of biasa Bonrath et al.26 2015 RCT Canada 18 - High Upgrade Large effects Buchwald et al.2 2006 Survey USA 251 - Low No downgrade 100% response Davis et al.5 2013 RetrospecOve USA N/A 6133 Low No upgrade Extent of resident involvement not reported Fanous et al.6 2012 Cohort USA 18 711 Very low Downgrade SelecOon biasa Extent of role of senior residents unclear. Harrington et al.25 2007 Cohort USA 12 23 Low No upgrade Small sample size, short observaOon period, no long term follow-up, yet prospecOve work Iordens et al.23 2012 RetrospecOve Europe 5 83 Low No upgrade RetrospecOve study, small sample size Leandros et al.19 2009 Survey Europe 73 - Low No upgrade Effects not that large MarOn et al.28 2010 Cohort USA Unclear 140 Very low No upgrade Small sample size, prospecOve database Moran-Atkin et al.27 2014 RCT USA 20 40 High No upgrade Risk of a[riOon bias Rovito et al.24 2005 RetrospecOve USA 5 200 Very low Downgrade Unclear resident learning curve, small sample size Varas et al.20 2012 Cohort Chili 25 - Moderate Upgrade Large effect Zevin et al.21 2012 Syst. Review Global N/A - Moderate No upgrade Good review, but no grading of mostly retrospecOve arOcles Zimmerman et al.22 2010 Cohort USA 36 - Low No upgrade Effects not that large RCT = randomized controlled trial, RYGB = Roux-en-Y gastric bypass. N/A = not applicable a Risk of bias assessed (Appendix I) 2 29 Current techniques of teaching and learning in bariatric surgical procedures

Quality Grading of Reports The quality grading of reports is displayed in Table 1. For a full overview, a risk of bias assessment is included in Appendix I. Most included studies were small and retrospective. Using the GRADE system, 2 randomized controlled trials (RCT) were graded as “high” with arguments to upgrade the grade for 1 RCT. Two studies provided moderate evidence. The remaining 12 publications provided low (n = 6) or very low (n = 4) graded evidence. Owing to the heterogeneity between the studies, reflected for instance in operating times and types of interventions, statistic comparison or pooling of data was not possible. Training Level and Assessment Most studies applied to senior surgical residents (postgraduate year 3-5). Trainees’ experience in minimal invasive surgery (MIS) was described in detail by Iordens et al. and Bonrath et al.23,26 The Global Ratings Scales, Objective Structured Assessment of Technical Skill (OSATS), Bariatric OSATS (BOSATS), and error counts were used for evaluation of the effects of various interventions.20,26,27 The resident and fellow education remarks are summarized in Table 2. Effects on Surgical Outcome Seven publications that included information on the effects of resident participation on surgical outcome are summarized in Table 3. The average difference in operation time is a decrease of 9.6 minutes (range: −93 to +40 minutes). After exclusion of studies that showed decreased operating room (OR) times due to simplification of the operative procedure, or severe inclusion bias, OR time was increased by 29.3 minutes (range: +13 to +40 minutes).24,28 Two studies described no difference in complication rates. Davis et al. described increased morbidity and return to operating room rates.5 Martin et al. found an overall decrease of early complications from 15% to 5% and a significant decrease in anastomotic strictures using a simplified technique.28 Fanous and Carlin reported increased rates of acute renal failure from 0% to 0.82% (p = 0.047).6 This study found a nonsignificant effect on excess weight loss (64% vs. 66%). Harrington et al., who reported on the effects of in vivo training of the jejunojejunostomy, found increased costs of $1457 per anastomosis (mean duration 93.5 minutes).25 30 2

Table 2: Study Populations and Teaching Methods Study Procedures Target Teaching method MIS experience Tests Azer et al.18 None Resident Online informaqon plarorm PGY 1-2 vs 3-5 Knowledge tests Bonrath et al.26 LRYGB Combinaqon Coaching during jejunojejunostomy vs no coaching PGY 3-5 MIS experience 0-50 a BOSATS OSATS error count Buchwald et al.2 LRYGB Combinaqon N/A N/A N/A Davis et al.5 LRYGB Combinaqon N/A PGY 1-2 vs 3-5 and fellows - Fanous et al.6 LRYGB Resident Whole procedure in vivo SSR - Harrington et al.25 LRYGB Resident Stepwise educaqon in vivo of jejunojejunostomy PGY 3-5 - Iordens et al.23 LRYGB Resident Stepwise educaqon in vivo of gastric bypass in three steps PGY 5-6 b MIS experience > 100 - Leandros et al.19 LSG Combinaqon Ex vivo training course Noted for surgeons - Marqn et al.28 LRYGB Resident Whole procedure simplified RYGB PGY 2-5 - MoranAtkin et al.27 LRYGB and LSG Combinaqon Warm-up vs. no warm-up PGY 1-3 vs 4-5 GRS Rovito et al.24 LRYGB Resident Stepwise educaqon in vivo of gastric bypass in three steps PGY 5 - Varas et al.20 LRYGB Resident Stepwise educaqon ex vivo of the jejunojejunostomy PGY 1 GRS Zevin et al.21 LRYGB Combinaqon Ex vivo training course N/A - Zimmerman et al.22 LSG Resident Ex vivo training course PGY 1-5 - (B)OSATS = (Bariatric) Objective Structured Assessment of Technical Skill, GRS = Global Rating Scale LRYGB = laparoscopic Roux-en-Y gastric bypass, MIS = minimal invasive surgery, PGY = postgraduate year, SSR = senior surgical resident a As primary surgeon b The Dutch curriculum spans 6 years 2 31 Current techniques of teaching and learning in bariatric surgical procedures

Table 3: Effects on Patient Outcomes and Costs Study OR 2me Early complica2ons Late complica2ons Surgical outcome Costs Davis et al.5 Increased 107 to 142 min Increased morbidity 4 to 5.2%. Increased return to OR 2.6 to 2.7% No differences - - Fanous et al.6 Increased 128 to 168 min No difference Increased acute renal failure 0 to 0.82% Nonsignificant 66 vs 64% EWL - Harrington et al.25 Increased 50 to 93.5 mina - - - $1457 per anastomosis Iordens et al.23 Increased 116 to 129 min No difference - - - Marqn et al.28 Decreased 209 to 116 min Decreased 15 to 5% Decreased strictures 10% to 3.6% - - Rovito et al.24 Decreased 213 to 170 min No differences No differences - - Varas et al.20 Increased 12 to 18.543.5 mina N/A N/A N/A - EWL = excess weight loss, OR = operating room, N/A = Not applicable a Study aimed to single step In Vivo Training Interventions Four studies described in vivo training interventions: a coaching program, a preoperative warm-up, and stepwise education.23,24,26,27 Bonrath et al. performed an RCT on the effect of surgical coaching.26 Their study focuses on the creation of the jejunojejunostomy as part of a laparoscopic RYGB. The study group of 18 participants was randomized between standard intraoperative coaching and standard coaching combined with “comprehensive surgical coaching,” i.e., extra operative video playback with self-reflection and feedback from a trained surgeon. This led to significant improvements in post training Bariatric Objective Structured Assessment of Technical Skill (BOSATS) scores (3.60 in control group vs. 3.90 in the intervention group, P = 0.017) and reduction of technical errors (18 in control group vs. 10 in 32 2

the intervention group, P = 0.003). The intervention group also showed significant improvement of the standard Objective Structured Assessment of Technical Skill (OSATS), BOSATS, and technical errors from their baseline to post training measurements (all P = 0.008). The coaching sessions (33 of 40 sessions recorded) took a median time of 25 (23-28) minutes, and 53 minutes of assessment of the procedures, video editing, and defining learning curves. All the participants in the intervention group found the coaching very useful. Moran-Atkin et al. also performed an RCT studying the effect of a preoperative warm-up on performance of residents and fellows on laparoscopic procedures including LSG and LRYGB expressed in global rating scales (GRS) scores. Significant enhanced performance was noted on depth perception (P = 0.02), bimanual dexterity (P = 0.01), and efficiency of movements (P = 0.03).27 In a Dutch study, Iordens et al. described their technique to teach residents the LRYGB.23 Over a 4-year period, a resident performed the last operation of a day dedicated to bypass surgery; in the other procedures, the resident was first assistant. Noted is that all 5 were postgraduate year (PGY) 5 to 6 residents with specific interest in advanced laparoscopic procedures. The residents learned the procedure step-by-step. In this way, residents operated on a total number of 83 patients. This resulted in a slight but significant increase in operating times from 116 minutes to 129 minutes (p ≤ 0.001). Complication rates of 18% in the control group vs. 22% in the group operated by residents did not differ significantly (P = 0.455). The study of Rovito et al. showed a similar design.24 The five PGY 5 students in this group performed at least 12 procedures each. The attending surgeons’ surgical time was 213 minutes, the residents’ mean 170 minutes. In both groups, 2 leaks occurred. Preoperative Intervention Five studies focused on intervention in the training before the operation theatre, 1 group changed the operative procedure to facilitate training and shorten the learning curve. Azer et al. implemented an Internet-based knowledge module on metabolic bariatric surgery to their general surgery curriculum.18 The largest effect was found in a subgroup analysis of residents who completed a bariatric rotation before the study period. Zevin et al. identified the available simulation-based training programs in addition to re-examining the learning curve of Roux-en-Y gastric bypass.21 2 33 Current techniques of teaching and learning in bariatric surgical procedures

They also proposed a 5-step, mostly ex vivo, metabolic bariatric surgery training curriculum, consisting of knowledge-based learning, a procedural task analysis, training in a laboratory environment before the last 2 steps, transfer of skills to the operating room, and granting privileges. The studies of Leandros et al., Varas et al., and Zimmerman et al. described advanced laparoscopic training courses focused on bariatric procedures.19,20,22 These wet lab and box trainer studies concluded the LRYGB and LSG, or steps of the procedures, can be trained ex vivo before transferring skills to the operating theatre even for PGY1 residents. In 2007, Harrington et al. performed a time-cost analysis on the LRYGB procedural step of the laparoscopic jejunojejunostomy.25 Their results showed that it would cost around $45,000 to give 15 senior residents the opportunity to perform 2 anastomoses. Part of their calculation was the educational time, and the extra 43 minutes of operation time residents needed compared to surgeons. Martin et al. reduced the learning curve by simplification and standardization of the operative technique, introducing a linear stapled anastomosis. In this study, PGY 2 to 5 residents performed 140 LRYGB surgeries. The average operating time was 116 minutes. A survey between the surgeons and residents showed the new technique to be faster and simpler, and easier to teach.28 DISCUSSION This systematic review is the first to focus on education of bariatric surgical procedures. Fourteen studies describing training aspects of the LRYGB and LSG were included. With the use of the educational database ERIC, attempted was made to include studies from an educational point of view; however, none of the search hits were suitable for inclusion. We will next asses the systematic review process, summarize the data on training and effect on patient outcomes, and propose how to implement these outcomes. A variety of methods to perform a systematic review are available. In this study, the GRADE technique was used because this system is suitable for both studies with a high and low level of evidence, and both RCTs and local initiatives were expected.17 This system not only assigns grades to the type of evidence but also offers clear guidelines for altering this grade with a downgrade or upgrade for the quality of this study. For health care education literature, 34 2

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