Single Incision Versus Standard Laparoscopic Appendectomy for Non-Perforated Appendicitis
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
- 否
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
Shawn St. Peter
MD
Children's Mercy Hospital Kansas City
