Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

Inclusion Criteria:

• Informed Consent Form (ICF) signed by the patient or his/her legal representative
• primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
• recurrence after former abdominal hernia repair WITH MESH
• recurrence after suture abdominal hernia repair CAN be included

Exclusion Criteria:

• no written informed consent
• patient under 18 years old
• emergency surgery (incarcerated hernia)
• patients with expected life time shorter than one year for example due to generalised malignancy
• BMI exceeding 40.0kg/m²
• contaminated surgical fields
• patients on immunosuppression, steroid therapy, constant pain therapy