Effects of Mini/One Anastomosis Gastric Bypass (MGB/OAGB) and Sleeve Gastrectomy (LSG) on Lower Esophageal Sphincter (LES) Function. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Modifications in terms of LES function
研究概览
简要总结
Background While several articles have reported about the effects of laparoscopic sleeve gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is expected to be the first randomized trial exploring and comparing these two interventions.
Setting "Federico II" University Hospital, Naples - ITALY.
Methods Fifty morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and 24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or MGB/OAGB.
Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss?
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
- •80 morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 40 pts) or MGB (arm 2 - 40 pts).-
排除标准
- •Patients lost at follow up. Cancer patients at any stage.
研究组 & 干预措施
Mini/One anastomosis gastric bypass
Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB)
干预措施: MGB/OAGB (Procedure)
Laparoscopic sleeve gastrectomy
Execution of a laparoscopic sleeve gastrectomy (LSG)
干预措施: LSG (Procedure)
结局指标
主要结局
Modifications in terms of LES function
时间窗: 12 months
Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? This will be measured by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)
Definition of the best procedure
时间窗: 12 months
Does one between the two procedures outperform the other one in terms of eventual LES area modifications? This will be measured in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)
次要结局
- Causes of eventual modifications of LES function in relationship with weight loss(6 months and 12 months)
- Causes of eventual modifications of LES function in relationship with a specific surgical procedure(6 months and 12 months)
研究者
Mario Musella MD
Associate Professor of Surgery
Federico II University