跳至主要内容
临床试验/NCT07321743
NCT07321743已完成不适用

A Comparative Study Between Stapled and Handsewn Intestinal Anastmosis in Emergency Laparotomy

Zagazig University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
intestinal leakage

研究概览

简要总结

The goal of this clinical trial is to compare the outcomes of emergency intestinal anastomosis after stapled and handsewn anastmosis. The main question it aims to answer are:

Is stapled intestinal anastmosis is better than handsewn anastmosis in emergency laparotomy?

Participants at surgical emergency unit:

  • Had intestinal anastmosis either by stapler or handsewn.
  • kept in hospital for follow up and detection of complications like wound infection and leakage.
  • Either discharged or managed according to the complications
  • Outcomes were compared between the two groups

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • patients admitted to emergency surgery and needed intestinal anastmosis

排除标准

  • patients below 18 years old
  • immune-compromised patients e.g. corticosteroids therapy, autoimmue disease

研究组 & 干预措施

handsewn group

Active Comparator

干预措施: emergency intestinal anastmosis surgery (Procedure)

stapled group

Active Comparator

干预措施: emergency intestinal anastmosis surgery (Procedure)

结局指标

主要结局

intestinal leakage

时间窗: from one day to two weeks after surgery

intestinal leakage output calculated in ml by weighing dressing or calculating the drain output

次要结局

  • operation time(from incision time to closure (0 to 5 hours))
  • bleeding(from one hour to two days after surgery)
  • hospital stay(from one day to one month after surgery)
  • post-operative pain(from one to three days after after surgery)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Reham Zakaria Mohamed Ahmed

lecturer of general surgery, Zagazig University

Zagazig University

研究点 (1)

Loading locations...

相似试验

Emergency Intestinal Anastmosis | 临床试验