Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Weightloss short term
研究概览
简要总结
The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
详细描述
Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.
The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.
An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.
Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).
Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).
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 will be randomized single blinded for one of two study arms/procedures. 3 years post-operative unblinding will be done for participants wishing this.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Weightloss short term
时间窗: 1, 3 and 5 years postoperatively
percentage excess weight loss
次要结局
- Weightloss long term(5-10 years postoperatively)
- Health related quality of life questionnaire(until 10 years postoperatively)
- Deficiencies in blood - red blood count(until 10 years postoperatively)
- Deficiencies in blood - electrolytes(until 10 years postoperatively)
- Number of patients with peroperative conversion to sleeve(until 10 years postoperatively)
- Complications short term(up to 30 days postoperatively)
- Complications long term(from 30 days until 10 years postoperatively)
- Revision of the bypass(until 10 years postoperatively)
- Comorbidities(until 10 years postoperatively)
- Deficiencies in blood - vitamins(until 10 years postoperatively)
- Reflux/dumping questionnaire(until 10 years postoperatively)
- Peroperative complications(until 10 years postoperatively)
研究者
L. van Hogezand
Coordinating investigator
St. Antonius Hospital