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临床试验/NCT05278117
NCT05278117已完成不适用

A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step

Zagazig University1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
1
主要终点
incisional hernia

研究概览

简要总结

Purpose: This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.

Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.

详细描述

This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.

Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.

研究设计

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

入排标准

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

入选标准

  • •BA Grade IA according to Björck's initial classification following midline laparotomy from various departments,
  • •≥ 18 years
  • •emergency or elective surgery

排除标准

  • •BA grade 1B,2,3, and 4 according to Björck's initial classification,
  • •< 18 years,
  • •primary laparotomy performed through a non-midline incision, open abdomen,
  • •if another laparotomy had been performed between the surgery for BA and the end of the follow-up period,
  • •concomitant intra-abdominal surgery, abdominal complications during BA surgery,
  • •adherent bowel to the defect edge that cannot be separated,
  • •patients lost during follow up,
  • •presence of intra-abdominal contamination that cannot be controlled radiologically,
  • •history of previous BA repair,
  • •stoma exteriorized from the midline primary wound,
  • •temporarily wound closure techniques,
  • •prior abdominal surgeries other than operation resulted in BA,
  • •prior abdominal wall hernia repair with or without mesh,
  • •history of collagen diseases

研究组 & 干预措施

complete burst abdomen repair

Experimental

complete burst abdomen repair

干预措施: outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh (Procedure)

结局指标

主要结局

incisional hernia

时间窗: 3.5 years

incidence of incisional hernia measured by clinical examination and computerized tomography by %

recurrent burst abdomen

时间窗: 3.5 years

incidence of recurrent burst abdomen by %

次要结局

  • incidence of surgical site infection(30 days)

研究者

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

Tamer Alsaied Alnaimy

assistant professour of general and laparoscopic surgery

Zagazig University

研究点 (1)

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