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临床试验/NCT07026201
NCT07026201已完成不适用

Primary Anastomosis After Left Colectomy in Emergency Cases

Ain Shams University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Incidence of Anastomotic Leakage Within 30 Days Post-Operatively

研究概览

简要总结

The aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of intervention.

详细描述

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting to the emergency department with obstructed left colon
  • Patients aged between 18 and 80 years old
  • Decision of laparotomy is made
  • Intraoperative conditions are favorable for anastomosis (e.g., good vascularity, no severe sepsis, no marked tissue edema, no thickened peritoneum)
  • Patient agrees to participate in the study

排除标准

  • Severe diffuse peritonitis (e.g., peritoneal thickening, thickened bowel loop, severe tissue edema, and pyogenic membrane)
  • Marked decreased tissue vascularity due to distension
  • Irresectable mass
  • Rectal mass
  • Patients refusing to participate in the study

结局指标

主要结局

Incidence of Anastomotic Leakage Within 30 Days Post-Operatively

时间窗: 30 days after surgery

* Description: Percentage of patients who develop an anastomotic leak as diagnosed clinically or radiologically * Unit of Measure: % of patients * Assessment Method: Clinical signs and imaging (e.g., contrast-enhanced CT scan)

Incidence of Surgical Site Infection

时间窗: 30 days after surgery

* Description: Percentage of patients who develop a surgical site infection within 30 days after the operation * Unit of Measure: % of patients * Assessment Method: Clinical evaluation and/or positive wound culture

次要结局

  • Incidence of Postoperative Ileus(From date of surgery until first bowel movement, assessed up to 7 days post-surgery)
  • Time to Restoration of Bowel Movement(Assessed up to 7 days post-surgery)
  • Length of Hospital Stay(Assessed up to 14 days post-surgery)
  • Readmission Rate Within 30 Days(Time Frame: 30 days post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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