NCT00070005Unknown3 期
A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Functional outcome as measured by a validated questionnaire
研究概览
简要总结
RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.
PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.
详细描述
OBJECTIVES:
Primary
- Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision.
Secondary
- Compare the quality of life of patients treated with these procedures.
- Compare anorectal function in patients treated with these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
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 adenocarcinoma of the rectum
- •T2 or T3 disease
- •Disease located in the mid- or distal rectum
- •No evidence of metastatic disease
- •No preexisting grade III or IV incontinence
- •Completed preoperative radiotherapy (5 x 5 Gy) before study entry
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Working knowledge of the Dutch language
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior radiotherapy to the pelvis
- •No prior colon resection
- •No prior anorectal surgery
- •No concurrent abdominoperineal resection
排除标准
- 未提供
结局指标
主要结局
Functional outcome as measured by a validated questionnaire
次要结局
- Quality life as measured by a validated questionnaire
- Anorectal function as assessed by anorectal manometry and barostat measurements
研究者
研究点 (9)
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