Scientific evidence for the updated guidelines on indications for metabolic and bariatric surgery (IFSO/ASMBS).

The 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) updated the indications for metabolic and bariatric surgery (MBS), replacing the previous guidelines established by the National Institutes of Health (NIH) over 30 years ago. The evidence supporting these updated guidelines has been strengthened to assist metabolic and bariatric surgeons, nutritionists, and other members of multidisciplinary teams (MDTs), as well as patients. This study aims to assess the level of evidence and the strength of recommendations compared to the previously published criteria.

A Core set of patient-reported outcome measures to measure quality of life in obesity treatment research.

The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters.

Development of the International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC) Grade-Based Guidelines on the Surgical Treatment of Obesity Using Multimodal Strategies: Design and Methodological Aspects.

Background: The prevalence of obesity is already a worldwide health concern. The development of straightforward guidelines regarding the whole available armamentarium (i.e., medical, endoscopic, and surgical interventions in conjunction with a guidance program) is paramount to offering the best multimodal approach to patients with obesity. Methods: The International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC) identified a panel of experts to develop the present guidelines. The panel formulated a series of clinical questions (based on the patient, intervention, comparison, and outcome conceptual framework), which have been voted on and approved. A GRADE methodology will be applied to assess the quality of evidence and formulate recommendations employed to minimize selection and information biases. This approach aims to enhance the reliability and validity of recommendations, promoting greater adherence to the best available evidence. Results: These guidelines are intended for adult patients with a body mass index (BMI) ≥ 30 kg/m2 who are candidates for metabolic bariatric surgery (MBS). The expert panel responsible for developing these guidelines comprised 25 panelists (92% were bariatric surgeons) and 3 evidence reviewers, with an average age of 50.1 ± 10.2 years. The panel focused on 3 key questions regarding the combined use of structured lifestyle interventions, approved obesity management medications, and endoscopic weight loss procedures with MBS. Conclusions: The complexity of obesity as a chronic disease requires a comprehensive knowledge of all the available and feasible therapeutic options. The IFSO-EC society felt the urgent need to develop methodologically valid guidelines to give a full picture and awareness of the possible surgical and non-surgical therapeutic strategies employed with a multimodal approach.

Scientific Evidence for the Updated Guidelines on Indications for Metabolic and Bariatric Surgery (IFSO/ASMBS).

The 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) updated the indications for Metabolic and Bariatric Surgery (MBS), replacing the previous guidelines established by the NIH over 30 years ago. The evidence supporting these updated guidelines has been strengthened to assist metabolic and bariatric surgeons, nutritionists, and other members of multidisciplinary teams, as well as patients. This study aims to assess the level of evidence and the strength of recommendations compared to the previously published criteria.

Single Anastomosis Duodeno-Ileostomy with Sleeve Gastrectomy/Single Anastomosis Duodenal Switch (SADI-S/SADS) IFSO Position Statement-Update 2023.

The single anastomosis duodeno-ileostomy with sleeve gastrectomy/single anastomosis duodenal switch (SADI-S/SADS) has gained attention as an alternative to the traditional biliopancreatic diversion with duodenal switch (BPD-DS). In 2021, IFSO endorsed SADI-S/SADS as a safe and effective procedure, underscoring the necessity for long-term multidisciplinary care and randomized controlled trials (RCTs). A task force was established to conduct a systematic review of current evidence on SADI-S/SADS to guide clinical practice. A systematic review was conducted across three databases, focusing on studies examining SADI-S/SADS and its outcomes. A total of 93 studies were analyzed. SADI-S/SADS demonstrated efficacy in weight loss and medium-to-long-term control of type 2 diabetes mellitus (T2DM), along with positive outcomes regarding hypertension and hyperlipidemia. However, its impact on other comorbidities remains inconclusive. Frequent nutritional deficiencies were identified, particularly in fat-soluble vitamins, anemia, and hypoalbuminemia. Despite significant efforts, high-quality evidence on SADI-S/SADS remains scarce, prompting IFSO to advocate for increased registry participation, publication of long-term studies, and more RCTs. Lifelong supplementation and monitoring for nutritional deficiencies are recommended. The current position statement will be reviewed in 2 years.

Feasibility and Safety Study of the Use of a New Robot (Maestro™) for Laparoscopic Surgery.

BACKGROUND: In laparoscopic surgery, telerobotic systems such as Da Vinci™ were developed, among other things, to give back exposure and vision control to the operating surgeon. However, new limitations such as the separation of the operating surgeon from the operating table, cost, and size were unveiled. A new device, Maestro™, appears promising in addressing these limitations. The current work evaluates the feasibility, safety, and surgeon satisfaction with the assistance provided by the Maestro System. METHODS: Non-consecutive patients who were candidates for laparoscopic digestive surgery were enrolled in a descriptive prospective, monocentric study. Case selection was solely based on the availability of the device, but not on the patient's characteristics. Surgery was performed by a leading surgeon with the help of one less experienced surgeon. Feasibility was defined by the maintenance of the initial surgical plan. Safety was assessed by the absence of serious adverse events related to the device and surgeon satisfaction was evaluated by a questionnaire following the intervention. RESULTS: All 50 procedures were completed without conversion in laparotomy and without adjustment of the surgical team. Four complications were recorded during the study; however, none related to the use of the Maestro System. In 92% of the cases, the surgeon was satisfied with the assistance provided by the Maestro System. CONCLUSIONS: In standard elective digestive procedures by laparoscopy, the use of the Maestro System is feasible and safe. It is beneficial to the surgeon and operative room organization by limiting the size of the surgical team.

Metabolic Bariatric Surgery Across the IFSO Chapters: Key Insights on the Baseline Patient Demographics, Procedure Types, and Mortality from the Eighth IFSO Global Registry Report.

INTRODUCTION: The International Federation for Surgery for Obesity and Metabolic Disorders (IFSO) Global Registry aims to provide descriptive data about the caseload and penetrance of surgery for metabolic disease and obesity in member countries. The data presented in this report represent the key findings of the eighth report of the IFSO Global Registry. METHODS: All existing Metabolic and Bariatric Surgery (MBS) registries known to IFSO were invited to contribute to the eighth report. Aggregated data was provided by each MBS registry to the team at the Australia and New Zealand Bariatric Surgery Registry (ANZBSR) and was securely stored on a Redcap™ database housed at Monash University, Melbourne, Australia. Data was checked for completeness and analyzed by the IFSO Global Registry Committee. Prior to the finalization of the report, all graphs were circulated to contributors and to the global registry committee of IFSO to ensure data accuracy. RESULTS: Data was received from 24 national and 2 regional registries, providing information on 502,150 procedures. The most performed primary MBS procedure was sleeve gastrectomy, whereas the most performed revisional MBS procedure was Roux-en-Y gastric bypass. Asian countries reported people with lower BMI undergoing MBS along with higher rates of diabetes. Mortality was a rare event. CONCLUSION: Registries enable meaningful comparisons between countries on the demographics, characteristics, operation types and approaches, and trends in MBS procedures. Reported outcomes can be seen as flags of potential issues or relationships that could be studied in more detail in specific research studies.

Effect of opioid-free versus opioid-based strategies during multimodal anaesthesia on postoperative morphine consumption after bariatric surgery: a randomised double-blind clinical trial.

Background: The efficacy and safety of opioid-free anaesthesia during bariatric surgery remain debated, particularly when administering multimodal analgesia. As multimodal analgesia has become the standard of care in many centres, we aimed to determine if such a strategy coupled with either dexmedetomidine (opioid-free anaesthesia) or remifentanil with a morphine transition (opioid-based anaesthesia), would reduce postoperative morphine requirements and opioid-related adverse events. Methods: In this prospective double-blind study, 172 class III obese patients having laparoscopic gastric bypass surgery were randomly allocated to receive either sevoflurane-dexmedetomidine anaesthesia with a continuous infusion of lidocaine and ketamine (opioid-free group) or sevoflurane-remifentanil anaesthesia with a morphine transition (opioid-based group). Both groups received at anaesthesia induction a bolus of magnesium, lidocaine, ketamine, paracetamol, diclofenac, and dexamethasone. The primary outcome was 24-h postoperative morphine consumption. Secondary outcomes included postoperative quality of recovery (QoR40), incidence of hypoxaemia, bradycardia, and postoperative nausea and vomiting (PONV). Results: Eighty-six patients were recruited in each group (predominantly women, 70% had obstructive sleep apnoea). There was no significant difference in postoperative morphine consumption (median [inter-quartile range]: 16 [13-26] vs 15 [10-24] mg, P=0.183). The QoR40 up to postoperative day 30 did not differ between groups, but PONV was less frequent in the opioid-free group (37% vs 59%, P=0.005). Hypoxaemia and bradycardia were not different between groups. Conclusions: During bariatric surgery, a multimodal opioid-free anaesthesia technique did not decrease postoperative morphine consumption when compared with a multimodal opioid-based strategy. Quality of recovery did not differ between groups although the incidence of PONV was less in the opioid-free group. Clinical trial registration: NCT05004519.

Metabolic and Bariatric Surgery in Patients with Obesity Class V (BMI > 60 kg/m2): a Modified Delphi Study.

BACKGROUND: Metabolic and bariatric surgery (MBS) is the preferred method to achieve significant weight loss in patients with Obesity Class V (BMI > 60 kg/m2). However, there is no consensus regarding the best procedure(s) for this population. Additionally, these patients will likely have a higher risk of complications and mortality. The aim of this study was to achieve a consensus among a global panel of expert bariatric surgeons using a modified Delphi methodology. METHODS: A total of 36 recognized opinion-makers and highly experienced metabolic and bariatric surgeons participated in the present Delphi consensus. 81 statements on preoperative management, selection of the procedure, perioperative management, weight loss parameters, follow-up, and metabolic outcomes were voted on in two rounds. A consensus was considered reached when an agreement of ≥ 70% of experts' votes was achieved. RESULTS: A total of 54 out of 81 statements reached consensus. Remarkably, more than 90% of the experts agreed that patients should be notified of the greater risk of complications, the possibility of modifications to the surgical procedure, and the early start of chemical thromboprophylaxis. Regarding the choice of the procedure, SADI-S, RYGB, and OAGB were the top 3 preferred operations. However, no consensus was reached on the limb length in these operations. CONCLUSION: This study represents the first attempt to reach consensus on the choice of procedures as well as perioperative management in patients with obesity class V. Although overall consensus was reached in different areas, more research is needed to better serve this high-risk population.

First human surgery using a surgical assistance robotics device for laparoscopic cholecystectomies.

BACKGROUND: Over the past 20 years, surgeons involved in soft tissue minimally invasive surgery have experienced the pros and cons of both conventional and tele-robotic laparoscopic approaches. The Maestro System, developed by Moon Surgical (Paris, France) aims to overcome the challenges inherent to both approaches thanks to a new concept that augments the surgeon's performance at the bedside during a laparoscopic procedure. METHODS: The current study aims to present the first human experience with laparoscopic cholecystectomy with the Maestro system on 10 patients. RESULTS: All ten procedures were completed successfully. No significant complications related to the use of the Maestro system werenoted. CONCLUSION: Our preliminary observations appear to support the benefits of the Maestro system in non-emergent laparoscopic cholecystectomies. It goes without saying that further research is necessary to demonstrate the safety of this approach in other procedures.

Innovative Bariatric Procedures and Ethics in Bariatric Surgery: the IFSO Position Statement.

With the rise in obesity and bariatric procedures worldwide, there has been a surge in new and innovative procedures that has been increasingly offered to patients. In this position statement, IFSO highlights the importance of surgical ethics in innovation and when offering new procedures. Furthermore, the task force reviewed the current literature to describe which procedures can be offered as mainstream outside research protocols versus those that are still investigational and need further data.

2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery.

MAJOR UPDATES TO 1991 NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR BARIATRIC SURGERY: Metabolic and bariatric surgery (MBS) is recommended for individuals with a body mass index (BMI) >35 kg/m2, regardless of presence, absence, or severity of co-morbidities.MBS should be considered for individuals with metabolic disease and BMI of 30-34.9 kg/m2.BMI thresholds should be adjusted in the Asian population such that a BMI >25 kg/m2 suggests clinical obesity, and individuals with BMI >27.5 kg/m2 should be offered MBS.Long-term results of MBS consistently demonstrate safety and efficacy.Appropriately selected children and adolescents should be considered for MBS.(Surg Obes Relat Dis 2022; https://doi.org/10.1016/j.soard.2022.08.013 ) © 2022 American Society for Metabolic and Bariatric Surgery. All rights reserved.

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.

Major updates to 1991 National Institutes of Health guidelines for bariatric surgery.

Innovative Bariatric Procedures and Ethics in Bariatric Surgery: the IFSO Position Statement.

With the rise in obesity and bariatric procedures worldwide, there has been a surge in new and innovative procedures that has been increasingly offered to patients. In this position statement, IFSO highlights the importance of surgical ethics in innovation and when offering new procedures. Furthermore, the task force reviewed the current literature to describe which procedures can be offered as mainstream outside research protocols versus those that are still investigational and need further data.

The first international Delphi consensus statement on Laparoscopic Gastrointestinal surgery.

BACKGROUND: Laparoscopic surgery has almost replaced open surgery in many areas of Gastro-Intestinal (GI) surgery. There is currently no published expert consensus statement on the principles of laparoscopic GI surgery. This may have affected the training of new surgeons. This exercise aimed to achieve an expert consensus on important principles of laparoscopic GI surgery. METHODS: A committee of 38 international experts in laparoscopic GI surgery proposed and voted on 149 statements in two rounds following a strict modified Delphi protocol. RESULTS: A consensus was achieved on 133 statements after two rounds of voting. All experts agreed on tailoring the first port site to the patient, whereas 84.2% advised avoiding the umbilical area for pneumoperitoneum in patients who had a prior midline laparotomy. Moreover, 86.8% agreed on closing all 15 mm ports irrespective of the patient's body mass index. There was a 100% consensus on using cartridges of appropriate height for stapling, checking the doughnuts after using circular staplers, and keeping the vibrating blade of the ultrasonic energy device in view and away from vascular structures. An 84.2% advised avoiding drain insertion through a ≥10 mm port site as it increases the risk of port-site hernia. There was 94.7% consensus on adding laparoscopic retrieval bags to the operating count and ensuring any surgical specimen left inside for later removal is added to the operating count. CONCLUSION: Thirty-eight experts achieved a consensus on 133 statements concerning various aspects of laparoscopic GI Surgery. Increased awareness of these could facilitate training and improve patient outcomes.

A Technique of Preserving Preexisting Fundoplication When Converting to Roux-en-Y Gastric Bypass.

BACKGROUND: The standard surgical treatment of gastro-esophageal reflux disease (GERD) consists of either 360° (Nissen, NFP) or 270° (Toupet, TFP) fundoplication. On some occasions, such as recurrent GERD and/or severe overweight, patients may benefit from conversion to Roux-en-Y gastric bypass (RYGB), which is however technically difficult. Most techniques of conversion involve unwrapping of the fundoplication. We developed a laparoscopic technique that includes preservation of the wrap, while constructing a standard small-pouch RYGB. We describe the surgical technique and report the short-term outcomes of our technique. METHODS: Consecutive patients underwent conversion of NFP to RYGB by our fundoplication preserving technique as described in surgical technique. Perioperative outcomes were assessed by analysis of the electronic patient records; progression of GERD symptoms and patient satisfaction were evaluated by an on-line questionnaire. RESULTS: Fourteen patients underwent the conversion. There were no peroperative complications and no conversions. Short-term complications were registered in 4 patients (Clavien-Dindo grade 1, n = 2; grade 2, n = 1 and grade 3a, n = 1). No long-term complications were reported. None of the participants reported significant GERD symptoms Patient satisfaction was good. CONCLUSION: We developed a laparoscopic technique of NFP to RYGB conversion, with preservation of fundoplication integrity, which appears to add to the safety and efficacy of the procedure.

Single Anastomosis Jejuno-ileal (SAJI): a New Model of Malabsorptive Revisional Procedure for Insufficient Weight Loss or Weight Regain After Roux-en-Y Gastric Bypass.

BACKGROUND: In case of insufficient weight loss or weight regain or relapse of weight-related comorbidities after Roux-en-Y gastric bypass (RYGB), other procedures such as reduction of a large gastric pouch and stoma, lengthening of the Roux limb, conversion to sleeve gastrectomy and/or bilio-pancreatic diversion with duodenal switch have been advocated. Single anastomosis jejuno-ileal (SAJI) is a new revisional simple operation performed after RYGB failure which adds malabsorption to the previous gastric bypass. METHODS: SAJI includes a single jejuno-ileal anastomosis specifically joining the ileum 250-300 cm proximal to the ileo-caecal valve and the jejunum 30 cm below the gastro-jejunal anastomosis on the Roux limb of the previous RYGB. Thirty-one patients underwent SAJI for insufficient weight loss and/or weight regain after RYGB. The percent total weight loss (%TWL) after RYGB and before SAJI was 21.8 ± 7.8. All SAJI operations were performed laparoscopically. The SAJI mean operating time was 145 min. RESULTS: Regarding weight loss after SAJI, %TWL is 27.2 ± 7.4, 31.2 ± 6.4, 33.7 ± 5.9 and 32.9 ± 5.2 at 12, 24, 36 and 48 months, respectively. Our series recorded a low rate of peri-operative and medium-term complications with a low grade of severity (Clavien-Dindo classification grade). One patient required reoperation 36 days after SAJI for epigastrium incarcerated incisional hernia at the previous RYGB laparotomy site. Mortality was 0. Comorbidity reduction/resolution after SAJI is 83.2% for type 2 diabetes mellitus, 42.8% for arterial hypertension, 72.8% for dyslipidemia and 45.3% for OSA. CONCLUSIONS: Treatment of failed RYGB is challenging. SAJI is a less complicated, purely low invasive malabsorptive operation that should reach satisfactory %TWL and comorbidity reduction/resolution.

Patient Selection in One Anastomosis/Mini Gastric Bypass-an Expert Modified Delphi Consensus.

PURPOSE: One anastomosis/mini gastric bypass (OAGB/MGB) is up to date the third most performed obesity and metabolic procedure worldwide, which recently has been endorsed by ASMBS. The main criticisms are the risk of bile reflux, esophageal cancer, and malnutrition. Although IFSO has recognized this procedure, guidance is needed regarding selection criteria. To give clinicians a daily support in performing the right patient selection in OAGB/MGB, the aim of this paper is to generate clinical guidelines based on an expert modified Delphi consensus. METHODS: A committee of 57 recognized bariatric surgeons from 24 countries created 69 statements. Modified Delphi consensus voting was performed in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was considered to indicate a consensus. RESULTS: Consensus was achieved for 56 statements. Remarkably, ≥ 90.0% of the experts felt that OAGB/MGB is an acceptable and suitable option "in patients with Body mass index (BMI) > 70, BMI > 60, BMI > 50 kg/m2 as a one-stage procedure," "as the second stage of a two-stage bariatric surgery after Sleeve Gastrectomy for BMI > 50 kg/m2 (instead of BPD/DS)," and "in patients with weight regain after restrictive procedures. No consensus was reached on the statement that OAGB/MGB is a suitable option in case of resistant Helicobacter pylori. This is likely as there is a concern that this procedure is associated with reflux and its related long-term complications including risk of cancer in the esophagus or stomach. Also no consensus reached on OAGB/MGB as conversional surgery in patients with GERD after restrictive procedures. Consensus for disagreement was predominantly achieved "in case of intestinal metaplasia of the stomach" (74.55%), "in patients with severe Gastro Esophageal Reflux Disease (GERD)(C,D)" (75.44%), "in patients with Barrett's metaplasia" (89.29%), and "in documented insulinoma" (89.47%). CONCLUSION: Patient selection in OAGB/MGB is still a point of discussion among experts. There was consensus that OAGB/MGB is a suitable option in elderly patients, patients with low BMI (30-35 kg/m2) with associated metabolic problems, and patients with BMIs more than 50 kg/m2 as one-stage procedure. OAGB/MGB can also be a safe procedure in vegetarian and vegan patients. Although OAGB/MGB can be a suitable procedure in patients with large hiatal hernia with concurrent hiatal hernia, it should not be offered to patients with grade C or D esophagitis or Barrett's metaplasia.