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临床试验/NCT03133533
NCT03133533撤回不适用

Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial

University of Florida2 个研究点 分布在 1 个国家开始时间: 2018年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Operative time

研究概览

简要总结

Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.

详细描述

Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • surgeon determined need for inguinal hernia repair

排除标准

  • < 18 years of age
  • > 99 years of age
  • medical indication for open repair

结局指标

主要结局

Operative time

时间窗: Immediate perioperative time

Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia.

次要结局

  • Postoperative pain score(Until 5 year postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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