NCT01071824Unknown不适用
Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision
Kantonsspital Liestal2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Pouch function 4 month after closure of protective ileostomy.
研究概览
简要总结
The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.
详细描述
No detailed description necessary, see brief summary.
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
- 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
- •all patients in need of rectal resection due to benign or malign disease
- •>=18 years
排除标准
- •anamnestic rectal resection
- •life expectancy of less than 2 years
- •pregnancy
- •<18 years
- •missing informed consent
研究组 & 干预措施
Transverse coloplasty pouch (Short limb)
Active Comparator
The short limb is the standard technique of transverse coloplasty pouch.
干预措施: Transverse coloplasty pouch (Short limb) (Procedure)
Transverse coloplasty pouch (Long limb)
Experimental
The long limb relates to straight coloanal anastomosis.
干预措施: Transverse coloplasty pouch (Long limb) (Procedure)
结局指标
主要结局
Pouch function 4 month after closure of protective ileostomy.
时间窗: 4 month
次要结局
- Pouch function 2 and 12 month respectively after closure of protective ileostomy.(1 year)
研究者
Christoph A. Maurer, MD
Prof. Dr. med. Christoph A. Maurer
Kantonsspital Liestal
研究点 (2)
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