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临床试验/NCT01203553
NCT01203553已完成不适用

Mesh Implantation for Prophylaxis of Incisional Hernia

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Incidence of incisional hernia

研究概览

简要总结

Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.

With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.

详细描述

Background

Incisional hernia is one of the most common complication in general abdominal surgery. An overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity.

In the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. With this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients'symptoms and to prevent progression of the hernia an possible complications.

Consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution.

Objective

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Occurrence of at least two of the following factors:
  • Male gender
  • Malignant tumor present
  • Body mass index above 25
  • Previous laparatomy
  • Elective operation
  • Patient > 18 years
  • Written informed consent
  • Exclusion Criteria
  • Previous intra-abdominal mesh placement
  • Emergency procedures
  • Previous incisional hernia
  • Inflammatory bowel disease

排除标准

  • 未提供

结局指标

主要结局

Incidence of incisional hernia

时间窗: 3 years

次要结局

  • Intraoperative complications(3 years)
  • Direct in-hospital costs(3 years)
  • Postoperative complications(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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