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Open Access Study protocol

A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene® Mesh Elastic versus the partly absorbable Ultrapro® Mesh for incisional hernia repair

Christoph Seiler1, Petra Baumann2, Peter Kienle3, Andreas Kuthe4, Jens Kuhlgatz5, Rainer Engemann6, Moritz v Frankenberg7 and Hanns-Peter Knaebel2*

Author Affiliations

1 University of Heidelberg, Department of Surgery, Heidelberg, Germany

2 Aesculap AG, Am Aesculap Platz, Tuttlingen, Germany

3 University of Mannheim, Department of Surgery, Mannheim, Germany

4 DRK-Hospital Clementinen, Hannover, Germany

5 Albert-Schweitzer Hospital, Department of Surgery, Northeim, Germany

6 Clinical Centre of Aschaffenburg, Department of Surgery, Aschaffenburg, Germany

7 Hospital Salem, Department of Surgery, Heidelberg, Germany

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BMC Surgery 2010, 10:21  doi:10.1186/1471-2482-10-21

Published: 12 July 2010

Abstract

Background

Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene® Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro® Mesh).

Methods/Design

In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention.

Discussion

This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients.

Trial registration

NCT00646334