Impact of Extent of Antral Resection on Surgical Outcomes of Sleeve Gastrectomy for Morbid Obesity (A Prospective Randomized Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- percent of excess weight loss
研究概览
简要总结
Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by both restrictive and hormonal action.
Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.
详细描述
This prospective randomized study was designed to compare between the beginning of sleeve gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative problems, weight loss, improvement of comorbidities, postoperative complications, nutritional and elemental deficiencies.
Consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG) at the department of general surgery, Mansoura University, Egypt, during the period from January 2008 to January 2012, were eligible for the study. The exclusion criteria included patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.
The operation was done under general anesthesia. Patient was in supine position with splitting of the operating table legs.Gastric transection started 2 cm proximal to the pylorus using 60 mm, green endo-stapler (Ethicon, USA) (GI) or 6 cm from the pylorus (G II). The following staplers were placed approximately 1 cm from the bougie in the direction of the gastroesophageal junction.
Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG)
排除标准
- •patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.
结局指标
主要结局
percent of excess weight loss
时间窗: one year postoperative
The percent of EWL was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.
次要结局
- length of postoperative stay(30 days)
- postoperative complications(one year postoperative)
- weight regain(one year postoperative)
- Resolution of comorbidity(one year postoperative)
研究者
Ayman El Nakeeb
Ass. Prof.
Mansoura University