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

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.NCT0064633470.000 incisional hernia repairs were performed in Germany in 2006 [1]. Incisional hernias can cause serious complications such as incarceration or strangulation, resulting in substantial costs for further treatment (~ 128 Million €). Optimal treatment has not yet been defined [2,3].Currently, the surgeon usually implants a mesh to reinforce the abdominal wall. The use of a mesh prosthesis for incisional hernia repair results in a lower recurrence rate than suture repair [4-11]. Creating a tension free repair with a mesh reduces the recurrence rate to 5-10%. Studies performed by Israelsson et al. in 2006 [12] and Kingsnorth et al. in 2004 [13] showed that the sublay technique seems to result in a lower recurrence rate (3-7%) compared to the onlay technique (12-19%). In order to achieve a sufficient reinforcement of the abdominal wall, the mesh should overlap the defect more than 5 cm in all directions [13-15]. Several meshes are available which differ in material, textile structure, pore size, weight, elasticity, tissue reaction, biocompatibility, and absorption [16-22]. Patients react differently to the mesh and the materials cause different complications