Prospective Evaluation of Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)

Overview

Obesity is a chronic disease that can be treated with metabolic and bariatric surgery when appropriate. This study will prospectively evaluate a new laparoscopic bariatric procedure called Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS). SIBS combines sleeve gastrectomy with a side-to-side connection between the first part of the duodenum and the ileum. Unlike standard single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S), the duodenum is not divided. Instead, the new connection is created while the duodenum remains intact, allowing food to continue through the normal duodenal pathway while also providing an additional pathway to the ileum. The connection is created laparoscopically using a conventional linear surgical stapler. The main purpose of this prospective study is to evaluate the technical feasibility and short-term safety of the SIBS procedure in adults undergoing metabolic and bariatric surgery. The study will assess whether the planned procedure can be completed successfully and will record postoperative complications occurring within 30 days after surgery. Participants will also be followed after surgery to evaluate weight loss, changes in body mass index, glycemic control and other obesity-associated medical conditions, nutritional status, gastrointestinal symptoms, hospital readmission, reoperation, and procedure-related complications. Follow-up assessments are planned for up to 12 months after surgery. The study is intended to provide prospective evidence regarding the safety, feasibility, and early clinical outcomes of this surgical approach. Longer-term and comparative studies will be needed to determine how its outcomes compare with established metabolic and bariatric procedures

This is a prospective, single-arm, open-label interventional study evaluating Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) in adults undergoing metabolic and bariatric surgery. Standard single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) combines sleeve gastrectomy with transection of the proximal duodenum and creation of a duodenoileal anastomosis. SIBS modifies this anatomical configuration by preserving continuity of the duodenum and creating a side-to-side duodenoileal anastomosis without duodenal transection. The rationale for this approach is to establish a duodenoileal pathway while avoiding creation of a blind-ending duodenal stump and maintaining continuity of the native proximal intestinal pathway. Whether these anatomical differences translate into clinically meaningful differences in safety, weight loss, metabolic outcomes, nutritional outcomes, or gastrointestinal function requires prospective evaluation. The procedure is performed laparoscopically. Sleeve gastrectomy is performed using standard bariatric surgical principles. An ileal loop is then identified at a protocol-defined distance proximal to the ileocecal valve and brought ante-colically to the first portion of the duodenum in an isoperistaltic orientation. Small enterotomies are created in the duodenum and ileum, and a conventional laparoscopic linear stapler is used to construct a side-to-side duodenoileal anastomosis. The common enterotomy is closed laparoscopically. The duodenum is not transected, thereby maintaining continuity of the native pyloro-duodenojejunal pathway in addition to the newly created duodenoileal pathway. Anastomotic integrity is assessed intraoperatively before completion of the procedure. The primary objectives of the study are to assess technical feasibility and short-term safety. Technical feasibility will be evaluated by successful laparoscopic completion of the planned SIBS procedure with creation of the side-to-side duodenoileal anastomosis while preserving an intact duodenum and without conversion to an alternative bariatric procedure or open surgery. Short-term safety will be evaluated by prospectively recording major postoperative complications occurring within 30 days after surgery. Perioperative outcomes will include operative time, estimated blood loss, conversion, length of hospital stay, postoperative complications, unplanned intervention, readmission, reoperation, and mortality. Particular attention will be given to complications potentially related to the duodenoileal anastomosis, including anastomotic leak, bleeding, obstruction, stenosis, ulceration, intra-abdominal collection, and other gastrointestinal complications. Participants will undergo standardized postoperative clinical and laboratory follow-up for up to 12 months. Weight-related outcomes will include body weight, body mass index (BMI), percentage total weight loss (%TWL), and percentage excess weight loss (%EWL) at predefined postoperative time points. Metabolic assessment will include glycemic measures such as glycated hemoglobin (HbA1c) and changes in treatment requirements among participants with type 2 diabetes mellitus or prediabetes. Changes in other obesity-associated medical conditions, including hypertension and dyslipidemia, will also be documented where applicable. Nutritional follow-up will include clinically appropriate laboratory assessment of hematological, protein, mineral, and micronutrient parameters according to the institutional metabolic and bariatric surgery follow-up protocol. Gastrointestinal symptoms and clinically relevant postoperative events will be prospectively recorded throughout follow-up. Where specified in the final study protocol, postoperative imaging may be used to assess anastomotic patency and passage of contrast through the native duodenojejunal and duodenoileal pathways. Any imaging or metabolic investigations performed specifically for research purposes will be predefined in the approved study protocol. The study is designed as an initial prospective evaluation of the feasibility, safety, and clinical outcomes of SIBS. It is not designed to establish superiority or noninferiority to SADI-S, Roux-en-Y gastric bypass, sleeve gastrectomy, or other established bariatric procedures. Findings from this study are intended to inform subsequent larger and comparative studies evaluating the longer-term effectiveness, metabolic effects, nutritional consequences, and safety of the procedure.