NCT00956241已完成不适用
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2002年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
研究概览
简要总结
The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.
详细描述
Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.
排除标准
- •Patients with a T1 or T4 tumor were excluded
- •Patients diagnosed with distant metastases
- •A medical history of colonic resection
- •Anorectal surgery or chemo- radiotherapy
- •Pre-existing fecal incontinence grade III or IV according to Parks10
- •Life expectancy of less than one year.
结局指标
主要结局
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
时间窗: 4 months
次要结局
- Quality of life(4 and 12 months)
- Function of the neo-rectum as assessed by the functional outcome questionnaire(12 months)
- Surgical results(4 and 12 months)
研究者
研究点 (2)
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