Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 18
- 主要终点
- Weight loss assessment according to Excess BMI Loss percentage (EBL%)
研究概览
简要总结
Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers.
More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.
By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery
Hypothesis :
The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.
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
- •Aged between 18 and 65 years old
- •Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)
- •Patient who has benefited from an upper GI endoscopy with biopsies
- •Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass
- •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 to a healthcare insurance plan
排除标准
- •History of esophagitis on upper GI endoscopy (Los Angeles classification)
- •Severe gastroesophageal reflux disease (GERD), resistant to medical treatment
- •Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy.
- •Presence of Helicobacter Pylori resistant to medical treatment
- •Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously
- •History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty)
- •Presence of a severe and evolutive life threatening pathology, unrelated to obesity
- •Presence of chronic diarrhea (≥ 3 loose or liquid stools per day, over a period of more than 4 weeks)
- •Pregnancy or desire to be pregnant during the study
- •Binge eating disorders or other eating disorders according to DSM V criteria
- •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
研究组 & 干预措施
Laparoscopic Omega Loop Bypass
Laparoscopic Mini-gastric bypass
干预措施: Laparoscopic Mini-gastric bypass (Procedure)
Laparoscopic Roux-en-Y Gastric ByPass
Procedure of reference in bariatric surgery
干预措施: Procedure of reference in bariatric surgery (Procedure)
结局指标
主要结局
Weight loss assessment according to Excess BMI Loss percentage (EBL%)
时间窗: 2 years after surgery
Weight loss assessment according to Excess BMI Loss percentage (EBL%), calculated using the following formula: ((BMI 2 years after surgery - initial BMI) / (initial BMI - 22.5)) X 100
次要结局
- Gastroesophageal reflux(The day before surgery (Day-1) and 6, 12, and 24 months after surgery)
- Modifications of the gastric and esophageal mucosa(2 years after surgery)
- Frequency of diarrhea(The day before surgery (day-1) and 6, 12, and 24 months after surgery)
- Waist size reduction according to absolute waist size (in cm)(1, 3, 6, 12, 18 and 24 months after surgery)
- Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%(1, 3, 6, 12, 18 and 24 months after surgery)
- Medical and surgical complication rates(1, 12 and 24 months after surgery)
- Type and severity of complications(During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications))
- Operative time(Recorded on the day of surgery (Day 0))
- Mean length of stay(Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days))
- Patient's quality of life(The day before surgery (D-1) and 6, 12 and 24 months after surgery)
- Metabolic and lipid profile(During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery)
- Nutritional status(During the period of inclusion (D-60 to D-2) and 6, 12, and 24 months after surgery (The 24-hour steatorrhea will be quantified at 6 months).)
- Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%(1, 3, 6, 12, 18 and 24 months after surgery)
- Waist size reduction according to absolute waist size (in cm)(1, 3, 6, 12, 18 and 24 months after surgery)
- Medical and surgical complication rates(1, 12 and 24 months after surgery)
- Type and severity of complications(During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications))
- Operative time(Recorded on the day of surgery (Day 0))
- Mean length of stay(Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days))
- Patient's quality of life(The day before surgery (D-1) and 6, 12 and 24 months after surgery)
- Metabolic and lipid profile(During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery)
- Dumping syndrome and hypoglycemia symptoms(At 1, 3,6,12,18 and 24 months after surgery)
- Gastroesophageal reflux(The day before surgery (Day-1) and 6, 12, and 24 months after surgery)
- Modifications of the gastric and esophageal mucosa(2 years after surgery)
- Frequency of diarrhea(The day before surgery (day-1) and 6, 12, and 24 months after surgery)
- Nutritional status(During the period of inclusion (D-60 to D-2) and 6, 12, and 24 months after surgery (The 24-hour steatorrhea will be quantified at 6 months).)