J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 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.
研究组 & 干预措施
j-pouch coloanal anastomosis
although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.
干预措施: j-pouch coloanal anastomosis (Procedure)
side-to-end coloanal anastomosis
in the Netherlands, the side-to-end anastomosis is the standard procedure to perform an anastomosis in case of rectal resection. therefore, the side-to-end group was our control group
干预措施: side-to-end coloanal anastomosis (Procedure)
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
- Function of the neo-rectum as assessed by the functional outcome questionnaire(12 months)
- Surgical results(4 and 12 months)
- Quality of life(4 and 12 months)