BIOLAP – Biological vs. synthetic mesh in laparoscopic hernia repair

Inguinal hernia repair is one of the most common operations globally. Recurrence and the occurrence of chronic pain are the remaining significant clinical problems. 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.

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.

The BIOLAP study is designed as a German national multicentre, prospective, randomized clinical study. The central element of our study design is self-control: Only patients with bilateral herniae will be included. Each patient will receive a biological mesh on one side, the other side will be repaired with a synthetic mesh. Randomization will preset which side is repaired with which material and study participants will not be informed about the location of each mesh type. 496 adult patients will be included, primary endpoints will be incidence of postoperative local pain and recurrent herniae within the first 2 years. Due to the self-controlled design, each patient is his/her own control preventing confounding factors as surgeon's experience and patient factors like metabolic disease.

Results cannot be shown yet since the trial has not finished. More than 30 patients have been operated within the study so far, a good feasability was reported by all surgeons. The surgical challenge lies in the still unfamiliar handling of the biological mesh, which has less inherent tension. While some meshes are easier too handle when dry, other need to be moist in order to fit through the trocar. In the study group meeting most surgeons reported to perform an atraumatic medial mesh fixation with glue to reduce the risk for recurrence.

Monitoring, including periodic on-site visits, was performed in compliance to the study protocol and GCP-standards. So far, no adverse effects occurred. As we compare CE-certified medical devices in their designated indication, without deviation from standard surgical technique, the medical risk is not different compared to routine clinical care.