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.

BMC Surgery
Christoph SeilerH P Knaebel

Abstract

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 abs...Continue Reading

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Citations

Aug 9, 2012·Hernia : the Journal of Hernias and Abdominal Wall Surgery·G TadeoR Cuesta
Mar 9, 2017·Revista do Colégio Brasileiro de Cirurgiões·Maria DE Lourdes Pessole Biondo-SimõesFlávio Daniel Saavedra Tomasich
Aug 21, 2015·Revista do Colégio Brasileiro de Cirurgiões·João Vicente Machado GrossiRicardo Breigeiron
Mar 19, 2016·Journal of Biomedical Materials Research. Part B, Applied Biomaterials·Steffen MetzlerHubert Scheuerlein
Feb 16, 2021·Langenbeck's Archives of Surgery·Nadav NevoE Karin

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NCT00646334

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