跳至主要内容
临床试验/NCT04808063
NCT04808063Unknown不适用

Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.

Hospital del Mar2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Incisional hernia

研究概览

简要总结

Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.

详细描述

Midline laparotomy complications have a high rate. When midline laparotomy is performed complications rate is even higher. One of the commons complications is incisional hernia, reaching up to 40%- 50% of cases in High risk groups.

Prophylactic mesh use has been proved to be useful preventing midline laparotomy in elective surgery. Despite this, there is not enough data to recommend its use in emergency surgery.

Aim of the study is to investigate if use of an algorithm of informed decision for use of prophylactic mesh in emergency midline laparotomy reduces incisional hernia incidence.

Prospective cohort study of all consecutive midline laparotomy performed at our emergency surgery department. Compare correct application of algorithm outcomes versus non correct application.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Emergency midline laparotomy.

排除标准

  • Surgical infection present at the moment of surgery.
  • Ventrla or incisional hernia present at the moment of laparotomy .
  • Open abdomen.
  • Preoperative American Society of Anesthesiologist score (ASA) of V.

结局指标

主要结局

Incisional hernia

时间窗: Durign first and second year of follow up

Diagnosis by clinical or image control of incicionsal hernia during follow up.

次要结局

  • Long term mesh related complications: chronic pain and mesh infection.(During first year of follow-up.)
  • Incidence os surgical site ocurrence complications(During first postoperative month.)

研究者

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

Alejandro Bravo Salva

Assistant doctor

Hospital del Mar

研究点 (2)

Loading locations...

相似试验

Algorithm for Prophylactic Mesh Use in Emergency... | 临床试验