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临床试验/NCT03133715
NCT03133715撤回不适用

Laparoscopic Versus Robot-assisted Ventral 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: 2019年5月1日最近更新:
适应症
干预措施

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 robot-assisted and laparoscopic ventral hernia repair surgery.

详细描述

Ventral 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 ventral hernia repair

排除标准

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

研究组 & 干预措施

laparoscopic ventral hernia

Active Comparator

laparoscopic ventral hernia repair

干预措施: laparoscopic repair (Procedure)

robot-assisted ventral hernia

Active Comparator

robot-assisted ventral hernia repair

干预措施: robot-assisted repair (Procedure)

结局指标

主要结局

Operative time

时间窗: perioperative time

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

次要结局

  • Post operative pain score(until year five post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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