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Open Access Study protocol

A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence

Jeroen Nieuwenhuizen1, Hasan H Eker2, Lucas Timmermans2*, Wim CJ Hop3, Gert-Jan Kleinrensink4, Johannes Jeekel4, Johan F Lange2 and PRIMA Trialist Group

Author Affiliations

1 Department of Surgery, LUMC, Leiden, The Netherlands

2 Department of Surgery, Erasmus MC, Rotterdam, The Netherlands

3 Department of Epidemiology, Erasmus MC, Rotterdam, The Netherlands

4 Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands

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BMC Surgery 2013, 13:48  doi:10.1186/1471-2482-13-48

Published: 28 October 2013

Abstract

Background

Incisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality. The overall incidence remains 11-20%, despite studies attempting to optimize closing techniques. Two patient groups, patients with abdominal aortic aneurysm and obese patients, have a risk for incisional hernia after laparotomy of more than 30%. These patients might benefit from mesh augmented midline closure as a means to reduce incisional hernia incidence.

Methods/design

The PRImary Mesh Closure of Abdominal Midline Wound (PRIMA) trial is a double-blinded international multicenter randomized controlled trial comparing running slowly absorbable suture closure with the same closure augmented with a sublay or onlay mesh. Primary endpoint will be incisional hernia incidence 2 years postoperatively. Secondary outcomes will be postoperative complications, pain, quality of life and cost effectiveness.

A total of 460 patients will be included in three arms of the study and randomized between running suture closure, onlay mesh closure or sublay mesh closure. Follow-up will be at 1, 3, 12 and 24 months with ultrasound imaging performed at 6 and 24 months to objectify the presence of incisional hernia. Patients, investigators and radiologists will be blinded throughout the whole follow up.

Disccusion

The use of prosthetic mesh has proven effective and safe in incisional hernia surgery however its use in a prophylactic manner has yet to be properly investigated. The PRIMA trial will provide level 1b evidence whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups.

Trial registration

Clinical trial.gov NCT00761475.