Safety, Feasibility, and Clinical Outcomes of Laparoscopic Side-to-Side Duodenoileal Bipartition Without Duodenal Transection Using a Conventional Linear Stapler: A Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Successful Technical Completion of the SIBS Procedure
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)
Participants assigned to this single study arm will undergo laparoscopic Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS). The procedure consists of sleeve gastrectomy followed by creation of a side-to-side duodenoileal anastomosis between the intact first portion of the duodenum and an ileal loop using a conventional laparoscopic linear stapler. The duodenum is not transected, preserving continuity of the native pyloro-duodenojejunal pathway while creating an additional duodenoileal pathway. Participants will undergo standardized postoperative follow-up to assess technical feasibility, perioperative safety, weight-loss outcomes, metabolic outcomes, nutritional status, and procedure-related complications
干预措施: Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) (Procedure)
结局指标
主要结局
Proportion of Participants With Successful Technical Completion of the SIBS Procedure
时间窗: During the index surgical 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
时间窗: From the day of surgery through postoperative day 30
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.
次要结局
- Percentage Total Weight Loss (%TWL) at 12 Months(12 months after surgery)
- Percentage Excess Weight Loss (%EWL) at 12 Months(12 months after surgery)
- Change in Body Mass Index From Baseline to 12 Months(Baseline to 12 months after surgery)
- Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months(Baseline to 12 months after surgery)
- Proportion of Participants With Type 2 Diabetes Remission at 12 Months(12 months after surgery)
- Operative Time(During the index surgical procedure)
- Estimated Intraoperative Blood Loss(During the index surgical procedure)
- Postoperative Length of Hospital Stay(From the day of surgery until hospital discharge, assessed up to 30 days)
- Proportion of Participants With Unplanned Hospital Readmission Within 30 Days(From hospital discharge through postoperative day 30)
- Proportion of Participants Requiring Unplanned Reoperation Within 30 Days(From the day of surgery through postoperative day 30)
- Proportion of Participants With Duodenoileal Anastomotic Leak Within 30 Days(From the day of surgery through postoperative day 30)
- Proportion of Participants With Duodenoileal Anastomotic Stenosis(From surgery through 12 months after surgery)
- Proportion of Participants With Duodenoileal Anastomotic Ulceration(From surgery through 12 months after surgery)
- Change in Selected Nutritional Laboratory Parameters From Baseline to 12 Months(Baseline to 12 months after surgery)
研究者
Mohammed Al Sibani
Senior Consultant General, MIS, and Bariatric Surgeon
Medical City for Military and Security Services