Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Changes in body-mass index (BMI)
研究概览
简要总结
This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.
详细描述
Sleeve gastrectomy is an established therapeutic option for morbidly obese patients without preexisting gastroesophageal reflux disease. The novel single anastomosis sleeve ileal bypass (SASI) procedure is already introduced in Norway at a private high-volume bariatric hospital. The purpose of this study is to evaluate the effects of SASI in comparison to an established bariatric procedure, i.e. sleeve gastrectomy. The primary end point is 2-year changes in BMI after sleeve gastrectomy and SASI.
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
- Single (Participant)
盲法说明
Patients are allocated to surgical treatment 2 weeks before surgery and blinded to treatment allocation until the first postoperative day.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbid obesity at referral for bariatric surgery (i.e. a body-mass index [BMI] of ≥35 kg/m2 with obesity-related comorbid conditions or ≥40 kg/m2 with or without such comorbidities).
- •Age 20-60 years.
- •Previous failed attempts of weight loss.
- •Norwegian speaking patients.
排除标准
- •BMI ≥55 kg/m
- •A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio).
- •Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery.
- •Previous or current gastroesophageal reflux symptoms with daily use of antireflux medication. Patients are also excluded if preoperative manometry identifies a hiatal hernia (≥4cm in axial length) or if preoperative upper endoscopy identifies esophagitis grade C or D (LA classification), peptic stricture, Barrett's esophagus, or esophageal carcinoma.
研究组 & 干预措施
Single anastomosis sleeve ileal bypass
A Single anastomosis sleeve ileal bypass procedure is performed.
干预措施: Single anastomosis sleeve ileal bypass (Procedure)
Sleeve gastrectomy
A sleeve gastrectomy procedure is performed.
干预措施: Sleeve gastrectomy (Procedure)
结局指标
主要结局
Changes in body-mass index (BMI)
时间窗: 2 year
Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.
次要结局
- Change in prevalence of esophagitis.(2 year)
- Change in prevalence of gastroesophageal reflux disease.(2 year)
- Complications(6 weeks (100 days for deaths), 2 year, 5 year)
- Obesity-related comorbid conditions.(2 year, 5 year)
- Vitamin concentrations(2 year, 5 year)
- Gastrointestinal symptoms(2 year, 5 year)
- Revisional surgery(2 year, 5 year)
- Health-related quality of life(2 year, 5 year)
- Obesity-related symptoms(2 year, 5 year)
- Gastroesophageal reflux disease symptoms(2 year, 5 year)
- Bowel habits(2 year, 5 year)
- Long-term changes in BMI(5 years)
- Body composition(2 years)
研究者
Torgeir Søvik
Principal Investigator
Oslo University Hospital