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NCT07765758

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

Sponsor: Medical City for Military and Security Services

View on ClinicalTrials.gov

Summary

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

Official title: Safety, Feasibility, and Clinical Outcomes of Laparoscopic Side-to-Side Duodenoileal Bipartition Without Duodenal Transection Using a Conventional Linear Stapler: A Prospective Interventional Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2027-12-31

Last Updated

2026-08-14

Healthy Volunteers

Conditions

Obesity Obesity Type 2 Diabetes Mellitus

Interventions

PROCEDURE

Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)

SIBS is a laparoscopic metabolic and bariatric procedure combining sleeve gastrectomy with a side-to-side duodenoileal anastomosis without duodenal transection. Following sleeve gastrectomy, an ileal loop at a protocol-defined distance from the ileocecal valve is brought ante-colically to the first portion of the duodenum. Small enterotomies are created in the duodenum and ileum, and a conventional laparoscopic linear stapler is used to construct the side-to-side anastomosis. The common enterotomy is closed laparoscopically. The duodenum remains intact, preserving the native pyloro-duodenojejunal pathway while creating an additional duodenoileal pathway. Anastomotic integrity is assessed intraoperatively before completion of the procedure.

Inclusion Criteria * Age 18-65 years. * Body mass index (BMI) ≥35 kg/m², regardless of the presence or severity of obesity-associated medical conditions; or BMI 30.0-34.9 kg/m² with type 2 diabetes mellitus or another clinically significant obesity-associated medical condition and inadequate weight loss or improvement following appropriate nonsurgical management. * Eligible for metabolic and bariatric surgery following multidisciplinary clinical assessment. * Considered suitable for laparoscopic Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) based on preoperative assessment. * For primary procedures, no previous metabolic or bariatric surgical procedure. * For revisional procedures, previous sleeve gastrectomy with a clinical indication for revisional metabolic/bariatric surgery and anatomy considered suitable for SIBS. * Able to understand the investigational nature of the SIBS procedure, its potential risks and benefits, and established alternative bariatric procedures. * Able and willing to provide written informed consent. * Willing and able to comply with the scheduled postoperative clinical, nutritional, laboratory, and study follow-up for at least 12 months. Exclusion Criteria * Age \<18 years or \>65 years. * Pregnancy or breastfeeding. * Planned pregnancy during the 12-month postoperative study period. * Contraindication to general anesthesia or laparoscopic metabolic/bariatric surgery. * Previous gastrointestinal surgery resulting in anatomy that precludes safe performance of the planned SIBS procedure, except previous sleeve gastrectomy in participants undergoing an eligible revisional procedure. * Intraoperative anatomy that prevents safe creation of a tension-free side-to-side duodenoileal anastomosis. * Active inflammatory bowel disease involving the small intestine. * Active gastrointestinal malignancy or other active malignancy for which the proposed operation or follow-up would be inappropriate. * Severe hepatic dysfunction, severe renal dysfunction, or another major systemic illness considered to confer an unacceptable operative or nutritional risk. * Pre-existing severe protein-calorie malnutrition or clinically significant nutritional deficiency that cannot be adequately corrected before surgery. * Active gastrointestinal ulceration or another gastrointestinal condition considered to substantially increase the risk of the planned procedure. * Uncontrolled psychiatric illness or cognitive impairment that precludes valid informed consent or adherence to postoperative care. * Active alcohol or substance use disorder considered incompatible with safe metabolic and bariatric surgery. * Inability or unwillingness to adhere to postoperative dietary recommendations, nutritional supplementation, or scheduled follow-up. * Any medical, surgical, anatomical, or psychosocial condition that, in the judgment of the multidisciplinary bariatric team, makes participation or performance of SIBS inappropriate or unsafe.

Locations (1)

Division of Bariatric and Metabolic Surgery, Medical City for Military and Security Services

Muscat, Oman