A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- surgical site infection
研究概览
简要总结
Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative classification. The ideal stoma site closure technique is still debated in the current literature. The aim of this study was to compare the rate of SSI following two different stoma closure techniques, primary closure versus a skin approximating purse string closure, in a multi-center randomized controlled trial. The investigators hypothesize that purse string closure technique will have a lower rate of SSI than primary closure technique.
详细描述
The investigators will randomize ileostomy takedown patients to either a primary closure or purse string closure technique intraoperatively. Surgeons at both the University of Minnesota and the CHUV hospital in Switzerland will participate in the this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no limitations based upon initial indication for formation of the ostomy. Indications for initial ostomy formation for fecal diversion can include: infection (e.g. diverticulitis) and protection of an anastomosis. (following resection for inflammatory bowel disease, benign diseases, or cancer)
排除标准
- •Subjects will be excluded from the study if:
- •The stoma site is left open to heal by secondary intention due to gross contamination (surgeon discretion)
- •The stoma site is re-used (i.e. the same stoma site used for the formation of a new ostomy)
- •A new stoma is created at a different site.
研究组 & 干预措施
Purse string closure
Patients undergo a purse string closure of their old stoma site.
干预措施: Purse string closure (Procedure)
Primary closure
Patients have their stoma sites close primarily with staples.
干预措施: Primary closure (Procedure)
结局指标
主要结局
surgical site infection
时间窗: 30 days postoperatively
次要结局
- delayed wound healing(30 days postoperatively)
- patient satisfaction(30 days postoperatively)