Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 40
- •ASA Class I or II
排除标准
- •Comorbid cardiac, pulmonary, renal, hepatic disease
- •Bleeding disorder
- •Previous gastric/esophageal surgery
研究组 & 干预措施
Single incision laparoscopic gastric banding
Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.
干预措施: Laparoscopic gastric banding (Procedure)
Five port laparoscopic gastric banding
Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions.
干预措施: Laparoscopic gastric banding (Procedure)
结局指标
主要结局
weight loss
时间窗: 1 month and 1 year post-operative
次要结局
- perioperative complication rate(1 month)
- quality of life(1 week and 3 months post-operative)