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

Einleitung:

Inguinal hernia repair is one of the most common surgical operations globally, more than 20 million groin hernias are repaired annually worldwide. Laparoscopic repairs provide very good results, and laparoscopic transabdominal inguinal hernia repair (TAPP) or total extraperitoneal hernia repair (TEP) are the two evaluated standard procedures. They provide equal results in terms of recurrence rates and pain. 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 of an advantage concerning occurrence of chronic pain due to a different postoperative remodelling without the disadvantages of a life-long implant.

We hypothesize that the use of a biological mesh reduces postoperative pain without being inferior in terms of recurrence rate compared with a synthetic mesh.

Material und Methoden:

We will conduct a blinded trial, self-controlled design meaning every patient is his/her own control. This is possible in bilaterally occurring diseases, preventing from confounding factors such as surgeon's experience and patient factors such as metabolic diseases, ability of wound healing etc. Biological mesh is used in hernia repair for one of the bilateral hernias. The other side will be operated with a synthetic mesh.

451 patients will have to be analysed, 15 centers will participate.

Primary endpoints will be the incidence of postoperative local pain separately evaluated for each operated side per patient and the incidence of recurrent hernia within the first 2 years after operation.

Ergebnisse:

Results cannot be shown yet since the trial has not finished. A DFG-funding about 1.087.663 € has been granted.

Schlussfolgerung:

There is no trial that assesses the use of biological meshes in laparoscopic hernia repair.

Our study design is really innovative as it allows a direct comparison of the two meshes with only very few confounding factors.

We think that our trial can clarify one of the most discussed topics in hernia surgery, so we want to present it and maybe motivate further centers willing to participate.