A Randomized, Controlled Trial to Compare the Functional Outcome and Quality of Life in Patients With Low Rectal Cancer Who Undergo a J Pouch or a Side to End Coloanal Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Improved function and capacity of the neorectum.
研究概览
简要总结
The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.
详细描述
The side to end anastomosis has become popular in recent years as it is technically simple to construct. The difference between the Baker type(side to end) of anastomosis and the J pouch, is that no formal pouch is constructed in the side to end. It has one staple line and the anastomosis.
The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study.
- •No evidence of distant metastatsis -
排除标准
- •Stage IV rectal cancer
- •History of radiation to the pelvis ( eg. for uterine or prostatic cancer)
- •Evidence of synchronus or metachronus disease
- •H/o dementia
- •Women who are pregnant
- •History of previous Right Colectomy
- •History of inflammatory bowel disease -
结局指标
主要结局
Improved function and capacity of the neorectum.
时间窗: 2 years from date of surgery
次要结局
未报告次要终点
研究者
Massarat Zutshi
MD
The Cleveland Clinic