Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Incisional hernia
研究概览
简要总结
Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that laparoscopic colon resection would result in fewer incisional hernias, prospective studies demonstrate a similar incidence to open surgery. Observational studies suggest that the rate of incisional hernia after laparoscopic colon resection may be reduced with the use of a transverse compared to a midline extraction incision. However, no randomized trails are available, and a midline extraction incision for hemicolectomy remains the standard current approach. The investigators hypothesize that the use of a lower abdominal transverse muscle splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer incisional hernias compared to a midline periumbilical extraction incision.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled laparoscopic partial colectomy where an abdominal extraction incision is planned
排除标准
- •previous laparotomy
- •rectal resection or anastamosis
- •planned pfannenstiel extraction incision
- •single site surgery
- •planned or performed stoma
- •BMI >35 kg/m2
研究组 & 干预措施
transverse incision
干预措施: laparoscopic colectomy (Procedure)
midline incision
干预措施: laparoscopic colectomy (Procedure)
结局指标
主要结局
Incisional hernia
时间窗: one year
次要结局
- surgical site infection(one month)
- body image(one year)
研究者
Dr. Liane S. Feldman
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
