BIOLAP study

The aim of this study is to show that the use of biological mesh material for the laparoscopic treatment of inguinal hernias (TEP or TAPP) results in significantly less pain postoperatively than the use of synthetic mesh material, without an increased recurrence rate.

The repair of inguinal hernias is one of the most common surgical procedures, with more than 20 million being treated each year. However, hernia recurrence is still a clinical problem and the occurrence of chronic pain after hernia repair is also problematic. Nowadays, it is common practice to use synthetic mesh material for the plastic. However, there is increasing evidence that biological mesh material offers advantages in terms of the occurrence of chronic pain due to the different postoperative remodelling without the disadvantages of a lifelong artificial implant.

BIOLAP is a blinded study with a self-controlled design, which is possible in bilateral diseases such as the bilateral primary inguinal hernias investigated here: Since each patient is implanted with the biological mesh on one side and the synthetic mesh on the other, all participants represent their own control. External factors such as the surgeon's experience or concomitant diseases therefore have no influence on the outcome. The primary endpoints of the study are pain reduction after six months and the recurrence rate after two years.