Spanish Experience with Latero-Lateral Duodeno-Ileostomy + Sleeve Gastrectomy with Magnet Anastomosis System.

BACKGROUND: The partial diversion of intestinal contents facilitates achieving and maintaining weight loss and improving glycemic control in patients with obesity and with or without T2DM. The purpose of this study is to report our experience and 1-year follow-up with novel modification of SADI-S. METHODS: This study is a part of a multicentric trial of patients that underwent primary side-to-side duodeno-ileostomy and sleeve gastrectomy (SG) with GT metabolic solutions magnetic anastomosis system. Feasibility, safety, and initial efficacy were evaluated. RESULTS: The mean age of the patients included was 48 ± 8.75 years and the preoperative BMI was 43.32 ± 2.82 kg/m2. The complications were present in 30% of patients. The anastomosis patency was confirmed by the passage of radiological contrast under fluoroscopy at a mean of 17 days (17-29 days), and the mean expulsion time was 42 days (32-62). The mean diameter of the anastomosis after the magnet expulsion was 13.8 × 11.4 mm. The percentage of total weight lost at 1 year was 38.68 ± 8.48% (p < 0.001). The percentage of excess weight loss 82.5 ± 18.44% (p < 0.001) and improvements in glucose profiles were observed. Mean baseline HbA1c 5.77 ± 0.31% was reduced to 5.31 ± 0.26% (p < 0.024). CONCLUSIONS: Latero-lateral duodeno-ileostomy + SG with magnetic duodenal bipartition is afeasible and reasonably safe technique and induces weight loss in patients with obesity and improvement of glycemic control. This modification could be considered as an option to standard SADI-S or as a first step in two stages procedure. However, larger studies are needed. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: #NCT05322122.

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results.

INTRODUCTION: Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. METHODS: In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality. CONCLUSION: In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

Early Bleeding After Laparoscopic Roux-en-Y Gastric Bypass: Incidence, Risk Factors, and Management - a 21-Year Experience.

PURPOSE: Morbidity and mortality associated with bariatric surgery are considered low. The aim of this study is to assess the incidence, clinical presentation, risk factors, and management of early postoperative bleeding (POB) after laparoscopic Roux-en-Y gastric by-pass (RYGB). MATERIALS AND METHODS: Retrospective analysis of prospectively collected data of consecutive patients who underwent RYGB in 2 expert bariatric centers between January 1999 and April 2020, with a common bariatric surgeon. RESULTS: A total of 2639 patients underwent RYGB and were included in the study. POB occurred in 72 patients (2.7%). Intraluminal bleeding (ILB) was present in 52 (72%) patients and extra-luminal bleeding (ELB) in 20 (28%) patients. POB took place within the first 3 postoperative days in 79% of patients. The most frequent symptom was tachycardia (63%). Abdominal pain was more regularly seen with ILB, compared to ELB (50% vs. 20%, respectively, p = 0.02). Male sex was an independent risk factor of POB on multivariate analysis (p < 0.01). LOS was significantly longer in patients who developed POB (8.3 vs. 3.8 days, p < 0.01). Management was conservative for most cases (68%). Eighteen patients with ILB (35%) and 5 patients with ELB (25%) required reoperation. One patient died from multiorgan failure after staple-line dehiscence of the excluded stomach (mortality 0.04%). CONCLUSION: The incidence of POB is low, yet it is the most frequent postoperative complication after RYGB. Most POB can be managed conservatively while surgical treatment is required for patients with hemodynamic instability or signs of intestinal obstruction due to an intraluminal clot.