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临床试验/NCT01567098
NCT01567098Unknown不适用

Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy: A Single Center Prospective Randomized Trial

Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
operation time

研究概览

简要总结

A randomized trial to study the null hypothesis:" single incision appendectomy does not take longer operation time when compared to conventional 3-port appendectomy". The study will be carried out in a tertiary referral center in Hong Kong with a catchment population of 1 million.

详细描述

Since the introduction of single incision laparoscopic surgery (SILS), this approach has become more popular and various case series and reports had described its feasibility in many general surgical procedures including appendectomy, cholecystectomy, and colectomy. Despite this, strong evidence in support of SILS to be equivalent or even superior to conventional multi-port approaches remain scarce, although there are case series and comparative studies with promising results in cholecystectomy and colectomy. There are many case series available stating that single incision appendectomy may be a feasible alternative to conventional approach, but may be at the expense of a longer operating time and a higher post operative wound pain score. A recent randomized trial by St. Peter et al. was the first to test the feasibility of this approach to standard 3-port approach in appendectomy in children. Under randomized settings of this trial the single incision appendectomy produced longer operating times and resulted in greater charges. However, the primary outcome measure in this trial was wound infection and the result showed no significant differences between the two approaches. The answer to whether single incision appendectomy produces a longer operating time when compared to conventional 3-port approach remained undetermined, in particular the adult population, and therefore a randomized trial design based on operating time as its primary outcome is desired.

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

入选标准

  • appendicitis score >5, imaging showed no complication from appendicitis

排除标准

  • pregnancy, mentally incapacitated, previous surgery

结局指标

主要结局

operation time

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Canon KO Chan, F.R.C.S. Ed.

Principal Investigator

Hospital Authority, Hong Kong

研究点 (1)

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