Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postoperative Pain
研究概览
简要总结
Bariatric surgery has been established as the best treatment for morbid obesity, compared with diet or medical treatment. Laparoscopic approach have improved the results of this surgery in terms of postoperative pain, reduction in the number of complications and hospital stay, as well as better cosmetic results. Conventional laparoscopic technique requires five to seven abdominal incisions to facilitate placement of the multiple trocars. New Single Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one incision is needed for the introduction of all trocars. Altough this technique can be performed with conventional laparoscopic instruments, new devides have been developed for facilitate this operations by SILS. The investigators think that reducing the number of incision would decrease the postoperative pain and improve cosmetic results in our patients, being a safe and technically feasible intervention supported by these special devices.
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
- None
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
- •Body Mass Index > 40
- •Body Mass Index > 35 with 2 mayor comorbidities
排除标准
- •Severe gastroesophageal reflux
- •Esophagitis grade B or higher
- •Midline periumbilical incision
- •Umbilical hernia >4cms.
结局指标
主要结局
Postoperative Pain
时间窗: 3 days
Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days
次要结局
- Cosmestic results(1,3 and 6 months)
- Operative time(Surgery)
研究者
Salvador Morales Conde
Innovation and Minimally Invasive Surgery Unit Cordinator
Hospitales Universitarios Virgen del Rocío
