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临床试验/NCT01039077
NCT01039077已完成不适用

Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年12月最近更新:
适应症

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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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