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BMC Surgery
Published in: BMC Surgery 1/2010

Open Access 01-12-2010 | 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

Authors: Christoph Seiler, Petra Baumann, Peter Kienle, Andreas Kuthe, Jens Kuhlgatz, Rainer Engemann, Moritz v Frankenberg, Hanns-Peter Knaebel

Published in: BMC Surgery | Issue 1/2010

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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
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Christoph Seiler
Petra Baumann
Peter Kienle
Andreas Kuthe
Jens Kuhlgatz
Rainer Engemann
Moritz v Frankenberg
Hanns-Peter Knaebel
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2010
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/1471-2482-10-21

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