NCT01110798Unknown不适用
Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer: Impact on Anastomotic Leak, Bowel Function and Quality of Life
Azienda Ospedaliera di Padova7 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Major anastomotic leak rate
研究概览
简要总结
RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.
PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.
详细描述
OBJECTIVES:
Primary
- To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis.
Secondary
- To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients.
- To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed rectal adenocarcinoma meeting the following criteria:
- •Mid and/or low rectal cancer
- •Tumor site ≤ 11 cm from anal verge
- •Must have a temporary stoma (ileostomy or colostomy)
- •Must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (R0-R1)
- •No locally recurrent disease
- •No distant metastasis
- •PATIENT CHARACTERISTICS:
- •Must be able to understand the study
- •PRIOR CONCURRENT THERAPY:
- •No prior handsewn coloanal anastomosis
- •No prior colonic resection
- •No prior surgery for local recurrence
排除标准
- 未提供
结局指标
主要结局
Major anastomotic leak rate
次要结局
- Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm
- Global anastomotic leak rate
- Anastomotic complications rate in addition to anastomotic leak
- Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires
研究者
研究点 (7)
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