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临床试验/NCT05359510
NCT05359510Unknown不适用

The Use of Different Types of Mesh at Different Sites in the Prevention of Incisional Hernia After Various Abdominal Incision Versus Primary Abdominal Suturing.

Assiut University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年4月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
early wound complications

研究概览

简要总结

The use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.

详细描述

The burden of incisional hernia after abdominal exploration has raised the question if a prophylactic mesh placement during abdominal wall closure is of benefit.

The reported rate of incisional hernia after abdominal incisions varies from 4.2% up to a calculated risk of 73%. The impact on quality of life and annual health care costs has motivated various groups to research ways to decrease the rate of incisional hernia by optimizing the technique of abdominal wall closure.

One of the crucial risk factors of the genesis of incisional hernias is the malfunction of collagen synthesis. Other main risk factors are found to be obesity, steroid therapy, malnutrition, nicotine abuse, and other connective tissue diseases.

Since German physician Theodor Billroth's first suggested use of prosthetic material to close the hernia defect in 1890, continued interest lead to the development of a variety of surgical meshes and techniques for suture and mesh reinforcement to prevent incisional hernia . Overtime, RCTs have demonstrated the effectiveness of the use of prophylactic mesh in the prevention of incisional hernia. While surgeons world over use different techniques of positioning mesh in the prophylactic mesh repair (PMR) such as the Onlay, Sublay and Intraperitoneal positions, which can be associated with a high incidence of complications such as the postoperative seroma.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent
  • patient age: ≥ 18 years
  • patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease

排除标准

  • age <18 years
  • navel site infection
  • pregnancy
  • expected survival <12 month
  • previous intra abdominal mesh placement

结局指标

主要结局

early wound complications

时间窗: 1 month

wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma

late wound complications

时间窗: 1 month

post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.

次要结局

  • incidence of incisional hernia(12 month)
  • complication rate(intraoperative complications will be recorded immediately after finishing the operation)

研究者

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

Kerolos Samer Shafik

Assistant Lecturer

Assiut University

研究点 (1)

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