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.
