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临床试验/NCT02023294
NCT02023294已完成不适用

Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy

Hospitales Universitarios Virgen del Rocío2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年4月1日最近更新:
适应症

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

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

发起方
Hospitales Universitarios Virgen del Rocío
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salvador Morales Conde

Innovation and Minimally Invasive Surgery Unit Cordinator

Hospitales Universitarios Virgen del Rocío

研究点 (2)

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