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
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.
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.
Single group
Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)
Procedure/SurgerySIBS 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.
Proportion of Participants With Successful Technical Completion of the SIBS Procedure
Technical success is defined as successful laparoscopic completion of the planned Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS), including creation of the side-to-side duodenoileal anastomosis with preservation of an intact, non-transected duodenum, without conversion to open surgery or conversion to an alternative bariatric procedure. The outcome will be reported as the number and percentage of participants who meet all criteria for technical success.
Proportion of Participants With Major Postoperative Complications Within 30 Days
Major postoperative morbidity will be defined as the occurrence of one or more complications classified as Clavien-Dindo grade III or higher within 30 days after surgery. This includes complications requiring surgical, endoscopic, or radiological intervention; life-threatening complications requiring intensive care management; and death. Events of particular interest include anastomotic leak, intra-abdominal collection, gastrointestinal bleeding, bowel obstruction, unplanned reoperation, and unplanned endoscopic or radiological intervention. Results will be reported as the number and percentage of participants experiencing at least one major complication.
Percentage Total Weight Loss (%TWL) at 12 Months
Percentage total weight loss will be calculated as: %TWL = \[(preoperative weight - postoperative weight) / preoperative weight\] × 100. The mean %TWL and corresponding measures of variability will be reported for participants with available 12-month follow-up data.
Percentage Excess Weight Loss (%EWL) at 12 Months
Percentage excess weight loss will be calculated as: %EWL = \[(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)\] × 100. Ideal body weight will be defined using the prespecified method in the study protocol. The mean %EWL and corresponding measures of variability will be reported.
Change in Body Mass Index From Baseline to 12 Months
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Change in BMI will be calculated as 12-month postoperative BMI minus preoperative BMI and reported as the mean change with corresponding measures of variability.
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Glycated hemoglobin (HbA1c) will be measured before surgery and at 12 months after surgery. Change in HbA1c will be calculated as the 12-month value minus the baseline value and reported in percentage points. Analyses will be performed for participants with available paired measurements, with additional assessment among participants with type 2 diabetes mellitus or prediabetes where appropriate.
Proportion of Participants With Contrast Passage Through Both Gastrointestinal Pathways
In participants undergoing protocol-specified postoperative upper gastrointestinal contrast imaging, passage of contrast through the native pyloro-duodenojejunal pathway and through the side-to-side duodenoileal pathway will be assessed. Dual-pathway patency will be defined as visualization of contrast passage through both routes without evidence of anastomotic obstruction. The number and percentage of evaluable participants demonstrating dual-pathway passage will be reported.
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