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临床试验/NCT01326052
NCT01326052已完成3 期

Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2004年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Saverio Mari

Reserch Fellows

University of Roma La Sapienza

研究点 (2)

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