BIOLAP: Biological versus synthetic mesh in laparoscopic hernia repair- a randomized multicenter, prospective, self-controlled clinical trial

• Applicant: Professor Dr. Markus Maria Heiss
• Subject Area: General and Visceral Surgery
• Term: since 2016
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 286663291

Inguinal hernia repair is one of the most common surgical operations globally, more than 20 million groin hernias are repaired annually worldwide. Recurrence after inguinal hernia operation is a considerable clinical problem. Another remaining problem after hernia surgery is the occurrence of chronic pain. Up to now, the use of synthetic meshes is the standard procedure, but there is raising evidence that biological meshes could be advantageous concerning occurrence of chronic pain due to a different postoperative remodeling, without the disadvantages of a life-long implant.The aim of this study is to show that that by using a biological matrix for laparo-endoscopic inguinal hernia repair (TEP or TAPP), the occurrence of postoperative pain is significantly reduced without it causing a higher recurrence rate.BIOLAP is a blinded trial with self-controlled design, which is possible in bilateral diseases such as the bilateral primary inguinal hernias examined here: since each patient receives the biological mesh on one side and the synthetic mesh on the other, each participant represents his own control. External factors such as the experience of the surgeon or concomitant diseases therefore have no influence on the result. Primary endpoints of the study are pain reduction after six months and recurrence rate after two years.

• DFG Programme: Clinical Trials
• Co-Investigator: Dr. Jürgen Meyer