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临床试验/NCT06506552
NCT06506552已完成不适用

Inferior Mesenteric Artery Preservation in Laparoscopic Colorectal Resection for Diverticular Disease; Short and Long Term Effects in Defecatory Function

University of Roma La Sapienza0 个研究点目标入组 300 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
主要终点
Defecatory disorders

研究概览

简要总结

This is a prospective randomized study aimed to verifying the short and long-term results of inferior mesenteric artery preservation following colorectal resection for diverticular disease

详细描述

This study wants to demonstrate that the preservation of the inferior mesenteric artery allow to improve postoperative defecatory function and improve patient's quality of life.

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

  • BMI < 35
  • ASA I-III
  • Hinchey I-III

排除标准

  • BMI > 35
  • Hinchey IV
  • Previous procedures that could have been modified the nervous mesenteric pattern (surgery, radiotherapy or chemotherapy)

结局指标

主要结局

Defecatory disorders

时间窗: 6 years from surgery

the presence of defecatory disorders was evaluated (Costipation, Evacuation frequency,evacuation urgency, fragmented evacuation,flatus incontinence, liquid incontinence)

次要结局

  • Postoperative surgical complication(1 month from surgery)
  • Constipation(6 years from surgery)
  • Incontinence(6 years from surgery)
  • Anorectal Muscles function(6 years from surgery)
  • Postoperative quality of life(6 years from surgery)

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, MD, PhD, FACS

Research fellow

University of Roma La Sapienza

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