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

Springer Science and Business Media LLC - Tập 10 - Trang 1-7 - 2010
Christoph Seiler1, Petra Baumann2, Peter Kienle3, Andreas Kuthe4, Jens Kuhlgatz5, Rainer Engemann6, Moritz v Frankenberg7, Hanns-Peter Knaebel2
1University of Heidelberg, Department of Surgery, Heidelberg, Germany
2Aesculap AG, Am Aesculap Platz, Tuttlingen, Germany
3University of Mannheim, Department of Surgery, Mannheim, Germany
4DRK-Hospital Clementinen, Hannover, Germany
5Albert-Schweitzer Hospital, Department of Surgery, Northeim, Germany
6Clinical Centre of Aschaffenburg, Department of Surgery, Aschaffenburg, Germany
7Hospital Salem, Department of Surgery, Heidelberg, Germany

Tóm tắt

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). 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. 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. NCT00646334

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2482/10/21/prepub

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