Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from preoperative time in anorectal function
研究概览
简要总结
The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 80 years
- •Presence of symptomatic diverticular disease
- •ASA I-III
排除标准
- •age > 80 years
- •Hinchey III-IV
- •Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
研究组 & 干预措施
Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
干预措施: Inferior Mesenteric Artery Preservation (Procedure)
Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
干预措施: Inferior Mesenteric Artery Ligation (Procedure)
结局指标
主要结局
Change from preoperative time in anorectal function
时间窗: 6 and 12 months
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
次要结局
- Constipation(6 and 12 months)
- Quality of life(6 and 12 months)
- Incontinence(6 and 12 months)
- Postoperative complication(1 month)
研究者
Francesco Saverio Mari
Reserch Fellows
University of Roma La Sapienza