Comparison of Functional Results of High Ligation and Low Ligation After Anterior Resection for Rectal Cancer - Randomized Controlled Trial-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of bowel function
研究概览
简要总结
The purpose of this study is to evaluate the defecatory function when nerve fibers around the inferior mesenteric artery(IMA) and left colic artery(LCA) are preserved(so called low ligation ) or not(high ligation) in the rectosigmoid and rectal cancer surgery.
详细描述
Fecal incontinence after anterior resection are often observed. Whether or not postoperative bowel function is influenced by the preservation of nerve fibers around the root of IMA and LCA (low ligation) is still unknown. So in this randomized controlled trial, we evaluate the efficacy of low ligation in terms of the bowel function.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On the basis of whether anterior resection was anticipated at WMUH for rectosigmoid and rectal cancer, and appropriate informed consent was obtained.
排除标准
- •Patients who could not respond to medical interview for own bowel function
- •Patients without an informed consent
研究组 & 干预措施
1
low ligation, which the IMA is ligated below the origin of the left colic artery
干预措施: preservation of nerve fibers around IMA (Procedure)
2
high ligation, which the IMA is ligated at its origin from the aorta
干预措施: resection of nerve fibers around IMA (Procedure)
结局指标
主要结局
Assessment of bowel function
时间窗: 1 year
次要结局
- comparison of leakage rate(2 weeks)
研究者
Hiroki Yamaue
Second Department of Surgery
Wakayama Medical University