Intragastric Balloons: Practical Considerations.

Obesity is escalating, projected to affect 17.5% of adults globally and afflict 400 million children by 2035. Managing this intricate and chronic condition demands personalized, multidisciplinary approaches. While dietary changes, lifestyle modifications, and medications yield short-term results, long-term outcomes are often poor, with bariatric surgery standing out as the most effective option. However, only a small fraction undergoes surgery due to various barriers. Intragastric balloon (IGB) emerges as a minimally invasive alternative, approved by major regulatory bodies. This review adresses the pivotal role of IGB in obesity management, delving into its history and technological evolution.

Novel Devices for Endoscopic Suturing: Past, Present, and Future.

Endoscopic suturing has been described in many applications, including the approximation of tissue defects, anchoring stents, hemostasis, and primary and secondary bariatric interventions. Primary endobariatric procedures use endoscopic suturing for gastric remodeling with the intention of weight loss. Currently, the only commercially available device in the United States is the OverStitch endoscopic suturing system (Apollo Endosurgery). We describe devices of potential that are currently in design and/or trials as devices for weight loss by gastric remodeling, including USGI incisionless operating platform used for the primary obesity surgery endoluminal 2.0 procedure, Endomina used for the Endomina endoscopic sleeve gastroplasty, and EndoZip.

How to Build an Endobariatric Practice: Set Up, Branding, and Marketing.

In the last decade there has been significant development of novel devices and techniques in the field of endoscopic bariatric and metabolic therapies (EBMTs). Bariatric endoscopy fulfills an unmet need within the current paradigm of obesity management. The expansion of this field is an important step in offering complete care to patients with obesity and metabolic disease. Nevertheless, information, mentorship and guidance through starting a practice in EBMTs are limited. We discuss important considerations when beginning a practice in obesity care with a focus on endobariatrics in a variety of practice settings.

The Future of Endobariatrics: Bridging the Gap.

With the growing global burden of obesity, the field of endobariatrics has emerged as a promising alternative, filling the void between lifestyle interventions with modest efficacy and more invasive surgical procedures. This article explores the latest advancements in endobariatric therapies, encompassing endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), endoscopic metabolic therapies, and promising pharmacologic and surgical combination approaches that integrate multiple therapeutic modalities. It also outlines the critical factors and strategic considerations necessary for the successful integration of endobariatric interventions into clinical practice.

Perioperative Outcomes Using Single-Fire Stapler.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is the most common bariatric surgery performed worldwide. The Titan stapler aims to standardize the sleeve gastrectomy by eliminating inconsistencies and simplifying the procedure. METHODS: A retrospective chart review was performed on all patients > 18 years of age undergoing LSG using the Titan. Pre-operative demographics, perioperative findings, and post-operative complications were all abstracted from the MBSAQIP database. RESULTS: A total of 807 LSG have been performed using the latest iteration of the Titan stapler since November 2022. Data from these patients was compared to 3829 patients who underwent LSG using a sequential staple firing technique from September 2016-September 2021. The median age of Titan patients was 42 years (IQR 33-52) compared to 44 years (IQR 35-54) for sequential firing. The median pre-operative BMI was 47.1 (IQR 43.5-52.1) for Titan versus 47.6 (IQR 43.1-53.3) for sequential staple firing. After propensity matching, operative duration was significantly less for the Titan. Titan patients had decreased hospital length of stay, experienced fewer 30-day readmissions, and had less post-operative nausea/vomiting. Post-op bleed rates were similar between the two cohorts. Weight loss at 6 months favored the sequential fire arm, but our preliminary data shows this difference diminishes at 1 year. CONCLUSIONS: Here we report our data on patients undergoing LSG using the latest Titan stapler. We show the device is safe, effective, and has resulted in an improvement in length of stay, readmissions, and post-operative nausea/vomiting. We also noted reduced operative time with this technique.

First modified Delphi consensus statement on robotic-assisted da Vinci sleeve gastrectomy.

BACKGROUND: Sleeve gastrectomy (SG) is the most commonly performed metabolic and bariatric surgery (MBS) procedure. Technical considerations related to the performance of SG are well established and reported in the literature but not in relation to robotic-assisted (RA) SG. We report the results of the first modified Delphi consensus-building exercise addressing technical considerations of RA da Vinci (dV) SG. OBJECTIVES: Develop best practices for the performance of robotic-assisted da Vinci sleeve gastrectomy. SETTING: Survey based consensus statement. METHODS: A consensus building committee (CBC) was created comprising 10 experts in the field of RA surgery and MBS based on strict selection criteria. The CBC developed 49 consensus statements which were then shared with 240 experts in RA surgery. Our stopping criterion was stability in responses (≤15%). The consensus cut point was 70%. RESULTS: The overall response rate was 49%. In the first round of voting, there was consensus agreement on 25 statements (51%), consensus disagreement on 14 (28%), and no consensus on the remaining statements (21%). In the second round of voting, we reached agreement on 3 additional statements. Experts recommended the use of the number of pauses generated by the stapler to guide choice of staple height (91.2%) and to upsize the staple height when using buttressing (92%). There was also consensus (81.4%) that the use of the closed staple height of 1.00 mm (white) is acceptable and that stapling of the antrum using a 1.5-mm staple (blue load) is also acceptable (73%). CONCLUSIONS: Collective expert opinion structured through a modified Delphi consensus statement presents a practical guide for surgeons interested in performing dV-SG.

Safety and Efficacy of Barbed Sutures Compared to Non-barbed Sutures in Bariatric Surgery: An Updated Systematic Review and Meta-analysis.

PURPOSE: Mastering intracorporeal suturing is challenging in the evolution from conventional to laparoscopic bariatric surgery. Among various techniques competing for superiority in overcoming this hurdle, we focus on exploring the potential of barbed sutures through a meta-analysis that compares outcomes to those of conventional non-barbed sutures in bariatric surgery. MATERIALS AND METHODS: We conducted a comprehensive search on PubMed, Scopus, and Embase to identify studies comparing barbed sutures with non-barbed sutures in bariatric surgeries, focusing on outcomes such as operative time, suturing time, postoperative complications, and hospital stay. The statistical analysis was carried out using RStudio version 4.3.2. Heterogeneity was assessed using the Cochrane Q test and I2 statistics. RESULTS: Incorporating data from 11 studies involving a total of 27,442 patients, including 3,516 in the barbed suture group across various bariatric surgeries, our analysis demonstrates a significant reduction in suturing time (mean difference -4.87; 95% CI -8.43 to -1.30; p < 0.01; I2 = 99%) associated with the use of barbed sutures. Specifically, in Roux-en-Y gastric bypass, we observed a significant decrease in operative time (mean difference -12.11; 95% CI -19.27 to -4.95; p < 0.01; I2 = 93%). Subgroup analyses and leave-one-out analyses consistently supported these findings. Furthermore, we found that the mean body mass index did not significantly predict the mean difference in operative time outcome. No significant differences emerged in hospital stay or postoperative complications, including leak, bleeding, stenosis, and bowel obstruction (p > 0.05). CONCLUSION: Our study findings address barbed sutures as a potential alternative for laparoscopic intracorporeal suturing in bariatric surgery.

Elastic Intra-corporeal Retractor for Bariatric and Upper Gastrointestinal Surgery.

INTRODUCTION: In minimally invasive upper gastrointestinal and bariatric surgery, proper organ retraction, especially liver retraction, is essential to achieve better per-operative precision and safety. Most currently used methods require specific material which might not be available in all hospitals. We introduce an easily reproducible low-cost trocar-less elastic intra-corporeal retractor (ICR). MATERIALS AND METHODS: ICR was created then used in two institutions where around 500 upper gastrointestinal and bariatric procedures are jointly performed yearly. Its design and application require an elastic rubber band, three staples, and a needle holder. For liver retraction, ICR is anchored to the right diaphragmatic crus and the anterior abdominal wall, creating a triangular shaped retractor. RESULTS: ICR requires around 2-3 min for application and can be easily repositioned for adequate exposure. Its trocar-less and intra-corporeal characteristics offer the advantage of decreasing the risk of bleeding, infection, and liver injury accompanying additional trocars, transcutaneous punctures and conventional retractors. CONCLUSION: ICR is a safe, effective, inexpensive, and easily reproducible intra-corporeal organ retractor which can be used in both laparoscopic and robotic bariatric surgery.

Endoscopic Gastric Plication: A Flexible and Tailored Alternative to Bariatric Surgery.

INTRODUCTION: Endoscopic procedures are expanding and have been evolving in recent years, increasing their volume along with the development of new devices. This is due to the low morbidity and complication rate, the reversibility of the procedures, and the positive impact on patients. Among the endoscopic procedures gaining interest is sleeve gastroplasty. It emerged as a feasible and safe alternative to traditional bariatric surgery. There are no guidelines available on the indications and use of endoscopic gastroplasty. The aim of this study is to present preliminary results of a case series of endoscopic gastric plication procedures performed for different options: as a primary endoscopic sleeve, as revision for sleeve gastrectomy, and as revision for gastric bypass. MATERIALS AND METHODS: A retrospective analysis was performed on a prospective database collecting data on all patients with obesity treated with endoscopic gastroplasty with the Overstitch™ (Apollo Endosurgery, Inc., Austin, Texas) device from 2022 to 2023 in the bariatric surgery unit. RESULTS: Twenty-three patients were treated from May 2022 to July 2023 with endoscopic gastric plication. Ten patients (43%) were submitted to primary endoscopic sleeve gastroplasty, three patients to revision of sleeve gastrectomy, one patient to revision of one anastomosis gastric bypass, and eight patients received a revision of Roux-en-Y gastric bypass. The body mass index (BMI) of patients submitted to primary ESG ranged from 33 to 42kg/m2, with a mean BMI of 37kg/m2. The age of the patients ranged from 22 to 70 years, with a mean age of 45. In one case, we registered a Clavien-Dindo 2 complication-an inflammatory perigastric reaction without a collection occurred 15 days after a primary ESG. CONCLUSION: Endoscopic gastric plication is emerging as a safe, mini-invasive, and effective procedure alternative to sleeve gastrectomy in patients with I or II class obesity or for those unfit for bariatric surgery. The endoscopic suturing device can be used both as a primary procedure or as a revisional option after failure of the primary surgery, thus proving to be a versatile option to provide to bariatric patients.

Promising effects of 33 to 36 Fr. bougie calibration for laparoscopic sleeve gastrectomy: a systematic review and network meta-analysis.

The standard size of bougie for laparoscopic sleeve gastrectomy (LSG) is not yet established. Therefore, a systematic review and network meta-analysis were conducted to assess the weight loss effects and associated complications of LSG for patients with morbid obesity, based on different bougie sizes. A total of 15 studies were reviewed in this systemic review and network meta-analysis (2,848 participants), including RCTs and retrospective studies in PubMed, and Embase until September 1, 2020. The effectiveness of different bougie calibration sizes was assessed based on excess weight loss (EWL), total complications, and staple line leak. Within this network meta-analysis, S-sized (≤ 32 Fr.) and M-sized (33-36 Fr.) bougies had similar effects and were associated with the highest EWL improvement among all different bougie sizes (S-sized: standardized mean difference [SMD], 10.52; 95% confidence interval [CI] - 5.59 to - 26.63, surface under the cumulative ranking curve [SUCRA], 0.78; and M-sized: SMD, 10.16; 95% CI - 3.04-23.37; SUCRA, 0.75). M-sized bougie was associated with the lowest incidence of total complications (M-sized: odds ratio, 0.43; 95% CI, 0.16-1.11; SUCRA, 0.92). Based on our network meta-analysis, using M-sized bougie (33-36 Fr.) is an optimal choice to balance the effectiveness and perioperative safety of LSG in the clinical practice.

Port-sharing techniques for laparoscopic cholecystectomy and sleeve gastrectomy.

In Japan, the number of bariatric surgeries performed has remained low. Thus, concomitant laparoscopic cholecystectomy (LC) with laparoscopic sleeve gastrectomy (LSG) is still relatively uncommon, but is increasing. We developed new port-sharing techniques for LC and LSG, which we performed on 26 obese Japanese patients with gall bladder (GB) diseases, using the LSG trocar arrangement and one additional trocar. We performed LC first, and after exchanging a port for a liver retractor in the epigastrium, we then completed LSG. One patient with an anomalous extrahepatic bile duct required one additional port. The mean LC time was 55 min, and the transition to LSG just after LC was smooth in all the patients. One patient suffered postoperative intraperitoneal hemorrhage, which was managed conservatively. Concomitant LC with LSG using port-sharing techniques is feasible and safe for obese Japanese patients with GB diseases.

EndoBarrier™ Implantation Rapidly Improves Insulin Sensitivity in Obese Individuals with Type 2 Diabetes Mellitus.

The EndoBarrier™ medical device is a duodenal-jejunal bypass liner designed to mimic the effects of gastric bypass surgery to induce weight loss and glycaemic improvement. In this study, 10 participants with type 2 diabetes mellitus (T2DM), a mean body mass index (BMI) of 43.3 ± 5.0 (kg/m2) and a mean glycated haemoglobin A1c (HbA1c) of 60.6 ± 8.6 mmol/mol were examined at baseline (before implantation of EndoBarrier™), 4 weeks after implantation, at 36 weeks (right before explantation) and 24 weeks after the removal of the device to explore the short and long-term effects on glucose metabolism. Besides a significant reduction in body weight and fat mass, EndoBarrier™ treatment significantly improved insulin sensitivity during Botnia clamp investigations after four weeks of implantation. The beneficial effects decreased over time but remained significant 24 weeks after removal of the device.

Magnetic Liver Retraction Decreases Postoperative Pain and Length of Stay in Bariatric Surgery Compared to Nathanson Device.

Objective: Retrospective case-matched comparison of magnetic liver retraction to a bedrail-mounted liver retractor in bariatric surgery specifically targeting short-term postoperative outcomes, including pain and resource utilization. Background: Retraction of the liver is essential to ensure appropriate visualization of the hiatus in bariatric surgery. Externally mounted retractors require a dedicated port or an additional incision. Magnetic devices provide effective liver retraction without the need of an incision. Methods: The sample consisted of primary and revisional bariatric surgery patients, including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and biliopancreatic diversion with duodenal switch (BPD-DS) operations. Propensity score analysis was used to match patients with magnetic retraction to patients with a bedrail-mounted retractor with a 1:2 ratio using preoperative characteristics. Baseline characteristics and postprocedure outcomes were compared using two-sample t-tests or Wilcoxon rank sum tests and chi-square or Fisher's exact test as appropriate. Results: One hundred patients met inclusion criteria for the use of magnetic liver retraction (45 RYGB, 35 SG, 20 BPD-DS) with 196 suitable matched external retractor patients identified. Patients were matched and comparable for all preoperative characteristics except for transversus abdominus plane block (27% versus 47%). Patients in the magnet cohort had significantly decreased mean 12-hour postoperative pain scores (2.9 versus 4.2, P = .004) and decreased hospital length of stay (LOS) (1.5 versus 1.9 days, P = .005) while operating room supply were higher in the magnet cohort ($4600 versus $4213, P = .0001). Conclusions: Magnetic liver retraction in bariatric surgery is associated with decreased postoperative pain scores, decreased hospital LOS, and increased operating supply costs.

A Preclinical Animal Study of Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner for Obesity and Metabolic Disease.

INTRODUCTION: Endoscopic bariatric and metabolic therapies can potentially reproduce similar gastric and small intestinal anatomic and physiologic manipulations as Roux-en-Y gastric bypass. This proof of concept animal study was aimed to assess the feasibility, safety, efficacy, and impact on gastrointestinal physiology of combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL) for the treatment of obesity. METHODS: Five Ossabaw pigs were fed a high-calorie diet to develop obesity and were randomly assigned to receive IGB or DJBL in sequence. The weight gain rate was calculated. Fasting and postprandial blood samples were drawn before any intervention (serving as the baseline group) and 1 month after second device insertion (serving as the combination group) to measure gut neurohormonal changes and metabolic parameters. RESULTS: Four pigs successfully received a sequential device insertion. One pig developed duodenal sleeve prolapse that was spontaneously resolved. One pig was early terminated because of developing a central line infection. The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone. A trend of higher postprandial glucagon-like peptide-1 was observed in the combination group compared with the baseline group. DISCUSSION: A combination of IGB and DJBL is feasible and well tolerated. A strategy of sequential use of these devices might offer a synergistic approach that can enhance weight loss and metabolic outcomes.

Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).

OBJECTIVE: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Endoscopic Treatments for Obesity: The Good, the Bad, and the Ugly.

In the current setting of an obesity pandemic, there is an urgent need for minimally invasive, safe, and effective interventions for weight loss. Endoscopic bariatric procedures have been developed as an alternative to more traditional medical and surgical therapies. Multiple options are undergoing evaluation or are already available for clinical use. This review aims to describe these treatments, including their mechanisms of action, efficacy, safety and the knowledge gaps regarding their use.

Computational Tools for the Reliability Assessment and the Engineering Design of Procedures and Devices in Bariatric Surgery.

Obesity is one of the main health concerns worldwide. Bariatric Surgery (BS) is the gold standard treatment for severe obesity. Nevertheless, unsatisfactory weight loss and complications can occur. The efficacy of BS is mainly defined on experiential bases; therefore, a more rational approach is required. The here reported activities aim to show the strength of experimental and computational biomechanics in evaluating stomach functionality depending on bariatric procedure. The experimental activities consisted in insufflation tests on samples of swine stomach to assess the pressure-volume behaviour both in pre- and post-surgical configurations. The investigation pertained to two main bariatric procedures: adjustable gastric banding (AGB) and laparoscopic sleeve gastrectomy (LSG). Subsequently, a computational model of the stomach was exploited to validate and to integrate results from experimental activities, as well as to broad the investigation to a wider scenario of surgical procedures and techniques. Furthermore, the computational approach allowed analysing stress and strain fields within stomach tissues because of food ingestion. Such fields elicit mechanical stimulation of gastric receptors, contributing to release satiety signals. Pressure-volume curves assessed stomach capacity and stiffness according to the surgical procedure. Both AGB and LSG proved to reduce stomach capacity and to increase stiffness, with markedly greater effect for LSG. At an internal pressure of 5 kPa, outcomes showed that in pre-surgical configuration the inflated volume was about 1000 mL, after AGB the inflated volume was slightly lower, while after LSG it fell significantly, reaching 100 mL. Computational modelling techniques showed the influence of bariatric intervention on mechanical stimulation of gastric receptors due to food ingestion. AGB markedly enhanced the mechanical stimulation within the fundus region, while LSG significantly reduced stress and strain intensities. Further computational investigations revealed the potentialities of hybrid endoscopic procedures to induce both reduction of stomach capacity and enhancement of gastric receptors mechanical stimulation. In conclusion, biomechanics proved to be useful for the investigation of BS effects. Future exploitations of the biomechanical methods may largely improve BS reliability, efficacy and penetration rate.

Novel and emerging devices and operations in the treatment of obesity in children and adolescents.

Obesity is among the most common and costly chronic disorders worldwide. Estimates suggest that in the United States obesity affects one-third of adults, accounts for up to one-third of total mortality, is concentrated among lower income groups, and increasingly affects children as well as adults. A lack of effective options for long-term weight reduction magnifies the enormity of this problem; individuals who successfully complete behavioral and dietary weight-loss programs eventually regain most of the lost weight. We included evidence from basic science, clinical, and epidemiological literature to assess current knowledge regarding mechanisms underlying excess body-fat accumulation, the biological defense of excess fat mass, and the tendency for lost weight to be regained. A major area of emphasis is the science of energy homeostasis, the biological process that maintains weight stability by actively matching energy intake to energy expenditure over time. Growing evidence suggests that obesity is a disorder of the energy homeostasis system, rather than simply arising from the passive accumulation of excess weight. We need to elucidate the mechanisms underlying this "upward setting" or "resetting" of the defended level of body-fat mass, whether inherited or acquired. The ongoing study of how genetic, developmental, and environmental forces affect the energy homeostasis system will help us better understand these mechanisms and are therefore a major focus of this statement. The scientific goal is to elucidate obesity pathogenesis so as to better inform treatment, public policy, advocacy, and awareness of obesity in ways that ultimately diminish its public health and economic consequences.

Technical review: Vertical sleeve gastrectomy in adolescents.

Sleeve gastrectomy is an effective tool for inducing sustainable weight loss in adolescents with obesity. It is a seemingly straight-forward procedure, and yet deceptive in technical nuances. This review highlights the technical preparation (equipment, patient positioning, pre-operative management), and conduct (anatomy, instruments, methodology, pitfalls) of the operation, and concludes with essentials for anticipating and managing complications of the operation. Throughout the discussion, we emphasize practical techniques to maintain patient safety while achieving maximum weight loss benefits.

Current and Future Endoscopic Weight Loss Solutions.

Obesity poses a significant health care concern in the United States, with 39.8% of adults being classified as obese. Several different methods have been introduced to combat obesity, from medical therapy to surgical options. Bariatric surgery has been demonstrated to be superior to medical therapy alone for weight loss in obese patients. Despite this information, only about 1% of eligible patients undergo bariatric surgery per year. The reason for this treatment gap is multifactorial, but patient apprehension to undergo surgery is a major driving force. Many patients perceive bariatric surgery as dangerous, and believe that living with their current weight is safer than undergoing surgery. To combat this treatment gap, endoscopic therapies have been developed to reach more patients in a less invasive way. This article will review endoscopic treatment options currently available and approved by the Food and Drug Administration, as well as other treatment modalities that are currently in development.