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.
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
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.


CONCLUSIONS
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.


BACKGROUND
NCT00646334.
Seiler
Christoph
C
University of Heidelberg, Department of Surgery, Germany.
Baumann
Petra
P
Kienle
Peter
P
Kuthe
Andreas
A
Kuhlgatz
Jens
J
Engemann
Rainer
R
V Frankenberg
Moritz
M
Knaebel
Hanns-Peter
HP
D020341:Absorbable Implants; D000328:Adult; D001672:Biocompatible Materials / Q000627:therapeutic use*; D002985:Clinical Protocols; D004146:Dioxanes; D004311:Double-Blind Method; D005260:Female; D006555:Hernia, Ventral / Q000601:surgery*; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010865:Pilot Projects; D011091:Polyesters; D011126:Polypropylenes; D011446:Prospective Studies; D013526:Surgical Mesh; D016896:Treatment Outcome
D001672:Biocompatible Materials; D004146:Dioxanes; D011091:Polyesters; D011126:Polypropylenes; C095495:glycolide E-caprolactone copolymer