Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Single-anastomosis Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 44
- 主要终点
- Excess Weight Loss measurement
研究概览
简要总结
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Nowadays, France is ranked 3rd in terms of bariatric surgeries performed per year.
Since the laparoscopic Roux-en-Y gastric bypass (RYGB) was described in 1977, this restrictive and malabsorptive procedure has become a gold standard for morbid obesity with an average Excess Weight Loss % (EWL%) of 72% at 2 years, and a strong metabolic effect, especially with regard to type 2 diabetes remission. Nevertheless, failures are observed (up to 20%), particularly in super obese patients, which are then difficult to manage. In this population, biliopancreatic diversion with duodenal switch (BPD-DS) is indicated due to its stronger weight loss and metabolic effect, but is still little performed worldwide because of its higher morbidity, surgical complexity and risk of malnutrition.
A novel technique combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction was introduced in 2007 by Sanchez-Pernaute, who described the single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as an evolution of the BPD-DS. With a 2.5-meter common channel, SADI-S seems to offer good results for the treatment of both morbid obesity and its metabolic complications, with an EWL% of up to 95% at 2 years and potentially less nutritional consequences.
To date, there is only one Spanish randomized trial comparing SADI-S to BPD-DS, whereas BPD-DS represents less than 1% of bariatric procedures in France and is only allowed in super obese patients. Thus only preliminary data of poor scientific value exists. Nevertheless, facing very encouraging short-term outcomes, there is a real need for a prospective trial comparing SADI-S to a standard bariatric procedure.
The aim of the investigator's study is to assess weight loss efficiency and the morbi-mortality of the SADI-S in comparison to a standard (RYGB), in order to validate this procedure among bariatric techniques
HYPOTHESIS SADI-S is superior to the standard RYGB for weight loss, increasing the EWL% by 10% (82% vs 72%, respectively) at 2 years.
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
- 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
- •Patient aged between 18 and 65 years old,
- •Morbid obesity with BMI ≥40 kg/m2 or BMI ≥35 kg/m2 associated with one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis)
- •Patient who has benefited from an upper GI endoscopy with biopsies to look for Helicobacter pylori , within the 12 months before surgery,
- •Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SADI-S or RYGB as a primary surgery or after failure of sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20%)).
- •Patient who understands and accepts the need for a long term follow-up,
- •Patient who agrees to be included in the study and who signs the informed consent form,
- •Patient affiliated with a healthcare insurance plan.
排除标准
- •History of previous bariatric surgery, other than a sleeve gastrectomy,
- •Presence of a severe and evolutive life threatening pathology, unrelated to obesity,
- •History of type 1 diabete,
- •History of chronic inflammatory bowel disease,
- •Pregnancy or desire to be pregnant during the study,
- •Presence of Helicobacter pylori resistant to medical treatment,
- •Presence of a unhealed gastro-duodenal ulcer or diagnosed less than 2 months previously,
- •Mentally unbalanced patients, under supervision or guardianship,
- •Patient who does not understand French/ is unable to give consent,
- •Patient not affiliated to a French or European healthcare insurance,
- •Patient who has already been included in a trial which has a conflict of interests with the present study
结局指标
主要结局
Excess Weight Loss measurement
时间窗: 2 years after surgery
For each surgical procedure, weight loss will be assessed 2 years after surgery using Excess Weight Loss percentage (EWL%), calculated using the following formula: ((weight at 2-year visit - initial weight) / (initial weight - ideal weight)) X 100 The assessment of the primary endpoint will be standardized between the centers and carried out under blind conditions.
次要结局
- Albumin(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Pre-albumin(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Hemoglobin(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Vitamin D(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Prothrombin rate(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Steatorrhea rate(6 month after surgery)
- Calcium(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Ferritin(At each study visit (before surgey and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Iron(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- % of transferrin saturation(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Vitamin A(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Vitamin B1(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Vitamin B12(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Vitamin B9(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Vitamin C(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Vitamin E(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- HbA1c(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Fasting glycemia(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Average number of stools per day(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- HDL(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- LDL(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Cholesterol(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Triglycerides(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Antidiabetic drugs(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Antilipidemic drugs(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Antihypertensive drugs(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea(Before surgery and 6, 12, 24, 60 and 120 months after surgery)
- Occurrence of kidney stones(Within 10 years after surgery)
- Length of stay(End of the hospitalization period)
- Readmission of patient(30 days after surgery)
- Overall complication rate(Within 10 years after surgery)
- Type and severity of early complications(Within 30 days after surgery)
- Type and severity of late complications(Within 10 years after surgery)
- Gastroesophageal reflux assessment(At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery))
- Absolute weight loss assessment(1, 3, 6, 12, 18, 24, 60 and 120 months after surgery)
- Excess Weight Loss percentage assessment(1, 3, 6, 12, 18, 24, 60 and 120 months after surgery)
- Excess BMI Loss percentage assessment(1, 3, 6, 12, 18, 24, 60 and 120 months after surgery)
- Quality of life assessed with GIQLI questionnaire(Before surgery and at 6, 12 and 24 months after surgery)
- Quality of life assessed with SF36 questionnaire(Before surgery and at 6, 12 and 24 months after surgery)
- Quality of life assessed with Sigstad questionnaire(Before surgery and at 1, 3, 6, 12, 24, 60 and 120 months after surgery)
- Evolution of food choices and preferences within 2 years after surgery(Before surgery and 3, 12 and 24 months after surgery)
- Number of reflux episodes lasting more than 5 minutes(60 and 120 months after surgery)
- Exposure time with pH < 4(60 and 120 months after surgery)
- Number of poor acid reflux(60 and 120 months after surgery)
- Modifications of the gastric and esophageal mucosa(60 and 120 months after surgery)
- Number of reflux episodes(60 and 120 months after surgery)
- Number of acid refluxes(60 and 120 months after surgery)
- Number of non-acid refluxes(60 and 120 months after surgery)
- Association with symptoms(60 and 120 months after surgery)