Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.
详细描述
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study
排除标准
- •Patients with secondary obesity due to endocrine disorders
- •patient unfit for general anesthesia.
- •patients who had not attempted non-surgical weight loss treatment in the past
- •patients with psychological conditions that influence his/her perception of the study protocol
- •patients with previous surgery for morbid obesity
研究组 & 干预措施
Gastric plication ileal bypass
single-anastomosis plication ileal bypass
干预措施: Gastric plication ileal bypass (Procedure)
结局指标
主要结局
weight loss
时间窗: 6 months
Percentage of excess weight loss at 6 months after the procedure
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University