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临床试验/NCT00981136
NCT00981136已完成不适用

Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2009年8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
360
试验地点
2
主要终点
Post-operative infection

研究概览

简要总结

This is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy.

The hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.

详细描述

This is a prospective, randomized clinical trial involving patients who present to the hospital with non-perforated appendicitis. We will offer enrollment to several institutions provided they receive institutional approval.

There are likely several parameters that will show small differences between groups, and this study will precisely quantify them to allow for adequate consultation from surgeons to families dealing with acute appendicitis. One theoretical concern over the SILS approach is that the exposure of the appendix to the wound could increase the rate of infectious complications; therefore, this is the primary outcome variable. The documented rate of infectious complications at our institution in patients with non-perforated appendicitis is 0.6%. An unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new technique. Using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or 180 in each arm.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication. Cosmetic scores will be obtained at 6 weeks and 6 months.

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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children under 18 years
  • Non-perforated appendicitis

排除标准

  • Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

结局指标

主要结局

Post-operative infection

时间窗: 6 weeks

次要结局

  • Doses of analgesic(3 days)
  • Operative time(1 day)
  • Cosmetic scores(6 months)
  • Length of Hospitalization(1 week)
  • Surgeon perception of difficulty(1 day)
  • Hospital/operative charges(1 week)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn St. Peter

MD

Children's Mercy Hospital Kansas City

研究点 (2)

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