Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Excess weight loss
研究概览
简要总结
Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.
Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.
With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had sleeve gastrectomy a minimum of 18 months before
- •still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL<50% or significant weight regain (≥20%EWL)
排除标准
- •general contra-indication for bariatric surgery
- •BMI<35kg/m2
- •pregnancy
- •cirrhosis
- •abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease
研究组 & 干预措施
biliopancreatic diversion with duodenal switch
Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
干预措施: Standard duodenal switch (Procedure)
Single-anastomosis duodeno-ileal anastomosis
Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)
干预措施: Single-anastomosis duodenal switch (Procedure)
结局指标
主要结局
Excess weight loss
时间窗: 12 month
Percentage of excess weight loss mobilized in response to surgery
次要结局
- Change in food addiction(from baseline to 60 months)
- Change in nutritional status (ferritin)(from baseline to 60 months)
- Change in quality of life (QLaval)(from baseline to 60 months)
- Change in food intake(from baseline to 60 months)
- Evolution of obesity related diseases(from baseline to 60 months)
- Change in nutritional status (iron)(from baseline to 60 months)
- Change in quality of life (BAROS)(from baseline to 60 months)
- Risk of malnutrition(from baseline to 60 months)
- Change in nutritional status (TIBC)(from baseline to 60 months)
- Change in nutritional status (vitamin A)(from baseline to 60 months)
- Peroperative complications(from baseline up to 60 months)
- Change in quality of life (SF-36)(from baseline to 60 months)
- Change in nutritional status (prealbumin)(from baseline to 60 months)
- Change in nutritional status (vitamin D3)(from baseline to 60 months)
- Change in eating behavior(from baseline to 60 months)
- Change in nutritional status (calcium)(from baseline to 60 months)
- Change in nutritional status (transferrin)(from baseline to 60 months)
- Change in nutritional status (parathormone)(from baseline to 60 months)
- Change in binge eating behavior(from baseline to 60 months)
- Gastro-intestinal side effects(from baseline to 60 months)
研究者
Laurent Biertho
Principal Investigator
Laval University