Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

Completed

• Conditions: Incisional Hernias

• Registration Number: NCT01203553
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

Detailed Description

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

* Occurrence of at least two of the following factors:

* Male gender

* Malignant tumor present

* Body mass index above 25kg/m2

* Previous laparotomy

* Elective operation

* Patient \>18 years

* Written informed consent

Methods

Prospective,two armed, controlled, randomized study

Study Timeline

• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Study Start: 2011-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of incisional hernia	3 years

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	3 years
Intraoperative complications	3 years
Direct in-hospital costs	3 years

Trial Locations

Locations (1)

Dep. of Visceral and transplant surgery, Berne University Hospital; 🇨🇭 Berne, Switzerland