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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Aortic Aneurysm

Treatments: Procedure: Conventional laparotomy closure; Procedure: Laparotomy closure with mesh augmentation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00757133

2008/379

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

1

Experimental group

Description:

Conventional laparotomy closure

Treatment:

Procedure: Conventional laparotomy closure

2

Active Comparator group

Description:

Laparotomy closure with mesh augmentation

Treatment:

Procedure: Laparotomy closure with mesh augmentation