Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
Vertical Sleeve Gastrectomy 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. The investigators 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 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 vertical sleeve gastrectomy
Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision.
干预措施: Laparoscopic vertical sleeve gastrectomy (Procedure)
Five port laparoscopic vertical sleeve gastrectomy
Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions.
干预措施: Laparoscopic vertical sleeve gastrectomy (Procedure)
结局指标
主要结局
Weight Loss
时间窗: 1 month and 1 year
次要结局
- Quality of life(1 week and 3 months)
- Peri-Operative Complications(1 month)