跳至主要内容
临床试验/NCT06016426
NCT06016426招募中不适用

Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children: a Randomized Clinical Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
wound failure with the development of incisional hernia later in either group

研究概览

简要总结

to assess two different ways of closure of laparotomy in children and infants

详细描述

Introduction:

The technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles.

There are two ways to close this laparotomy incision. These ways are either closure in mass or layer by layer closure. Neither of them is superior to the other.

The main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia.

The aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
3 Months 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • all infants and children with transverse laparotomy

排除标准

  • previous abdominal operations
  • children and infants with congenital abdominal wall defects

结局指标

主要结局

wound failure with the development of incisional hernia later in either group

时间窗: one year

the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children

次要结局

  • surgical site infections(two weeks up to one month)

研究者

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

Mohammad Gharieb Mohammad Khirallah

professor of pediatric surgery

Tanta University

研究点 (2)

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