Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Excess weight loss
研究概览
简要总结
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
详细描述
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.
However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.
Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.
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
- Double (Participant, 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
- •Age ≥18 years and ≤60 years
- •Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
- •Give written informed consent
排除标准
- •Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
- •Presence of the following baseline comorbidities:
- •Inflammatory bowel disease (IBD),
- •Cirrhosis
- •History of gastric or duodenal ulcers
- •Preoperative hypoalbuminemia (<35 g/L)
- •History of severe renal, hepatic, cardiac or pulmonary disease
- •Past esophageal, gastric or bariatric surgery
- •Type 1 Diabetes
- •Pregnancy
- •Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations
- •History of drug use or alcohol abuse in the last 6 months
- •History of gastro-intestinal inflammatory diseases
结局指标
主要结局
Excess weight loss
时间窗: 2 years
Excess weight loss at 2 years of follow-up %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values
BMI
时间窗: 2 years
change in BMI at 2 years follow-up as compared to preoperative reference values
Rate of protein deficiency or insufficiency
时间窗: from baseline up to 60 months
Rate of protein deficiency (\<35gr/l) or insufficiency (\<30gr/l)
Mortality rate
时间窗: from baseline up to 60 months
Rate of mortality
次要结局
- Cure rate of comorbidities(from baseline up to 60 months)
- Rate of minerals and vitamin deficiencies(from baseline up to 60 months)
- Complication rate(from baseline up to 60 months)
- Body composition by bioimpedance measures(from baseline up to 60 months)
- Change in quality of life(from baseline up to 60 months)
- Change in gatroesophageal reflux symptom(from baseline to 60 months)
研究者
Laurent Biertho
Principal Investigator
Laval University