Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- safety of the technique
研究概览
简要总结
The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy
详细描述
In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- •Approval to share in the study
- •Patients fit for laparoscopic surgery
排除标准
- •Patient age less than 18 or more than 50 years old
- •Refusal to share in the study
- •Unfit for surgery
- •patients with gastroesophageal reflux disease clinically or by investigation
研究组 & 干预措施
Laparoscopic internal gastric banding
Laparoscopic internal gastric banding
干预措施: Laparoscopic internal gastric banding (Procedure)
Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy
干预措施: laparoscopic sleeve gastrectomy (Procedure)
结局指标
主要结局
safety of the technique
时间窗: 4 weeks
the incidence of introperative and early postoperative complications
次要结局
- Hospital stay(30 days)
- Metabolic effect(6-12 months)
- operative time(12 hours)
- total cost(16 weeks)
研究者
Alaa Mstafa Hassan Sewefy
MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt
Minia University