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

Not Applicable

Completed

• Conditions: Aortic Aneurysm
• Interventions: Procedure: Conventional laparotomy closure; Procedure: Laparotomy closure with mesh augmentation

• Registration Number: NCT00757133
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-22
• Study Start: 2008-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial.
• All patients should sign the informed consent.

Exclusion Criteria

• Patients below 18 years.
• Pregnancy.
• Emergency surgery for aortic aneurysm.
• Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Conventional laparotomy closure	Conventional laparotomy closure
2	Laparotomy closure with mesh augmentation	Laparotomy closure with mesh augmentation

Primary Outcome Measures

Name	Time	Method
To 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 Incidence of incisonal hernia	2 years postoperatively

Secondary Outcome Measures

Name	Time	Method
Occurrence of post-operative complications	After 1 month
Duration of surgery	After surgery
VAS scores of pain at rest	12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery
Incidence of incisonal hernia	1 year and 5 years after surgery

Trial Locations

Locations (8)

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Sint Augustinus (GZA ziekenhuizen); 🇧🇪 Wilrijk, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

CHU Sart Tilman; 🇧🇪 Liège, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

AZ Maria Middelares Ghent; 🇧🇪 Ghent, Belgium

Stedelijk Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium