Clinical Trials Directory

Trials / Completed

CompletedNCT00757133

Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment

Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.

Conditions

Interventions

TypeNameDescription
PROCEDUREConventional laparotomy closureRecommended technique: The laparotomy is closed with a slowly resorbable running suture (f.e. PDS) in a single layer. The length of the suture should approximately be four (4) times the length of the fascial incision. The skin is closed with the usual technique of the department
PROCEDURELaparotomy closure with mesh augmentationRecommended technique: Mesh augmentation can be done in a retromuscular or a prefascial position. By consensus of the initial primary investigators a retromuscular (sublay) position of the mesh was chosen and as a mesh a light weight polypropylene mesh will be used. Retromuscular (sublay): (see reference no. 11: Rogers et al.) At the end of the vascular procedure the plane behind the rectus muscles (retromuscular-preperitoneal) is dissected as in a "Stoppa repair for incisional hernias"

Timeline

Start date
2008-11-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2008-09-22
Last updated
2014-12-05

Locations

8 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00757133. Inclusion in this directory is not an endorsement.