Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Quality Of Life (GQLI - Questionnaire)
研究概览
简要总结
The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.
详细描述
In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anastomosis ≤ 5cm from anal verge
- •age >18 years
- •informed consent
- •uneventful course after first operation
排除标准
- •pregnancy
- •allergy to contrast agent
- •severe non-surgical complications
- •evident abdominal - pelvic complications
研究组 & 干预措施
2 weeks
Ileostomy closure after 2 weeks
干预措施: Ileostomy closure (Procedure)
12 weeks
Ileostomy closure after 12 weeks
干预措施: Ileostomy closure (Procedure)
结局指标
主要结局
Quality Of Life (GQLI - Questionnaire)
时间窗: 6 weeks
Quality Of Life Survey using the GQLI - Questionnaire
次要结局
- Safety as assessed by Morbidity, Mortality(6 weeks, 16 weeks)
- Feasibility (via Visual Analogue Scale)(intraoperatively)
- Quality Of Life (GQLI - Questionnaire)(preOP, 16 weeks)
- Quality Of Life (EORTC - Questionnaire)(preoperative (preOP), 6 weeks, 16 weeks)