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临床试验/NCT00070005
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)18 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
100
试验地点
18
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

入选标准

  • 未提供

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 (18)

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