Comparison of Cousin Biotech® Adhesix* versus conventional mesh in open anterior inguinal hernia repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

Inguinal hernia repair coincides with a high rate of postoperative pain,
extending to over a year in 10-20% of patients. Although this is of major
concern, early postoperative pain also has an important impact on patients and
their ability to regain normal work and activities. Since inguinal hernia
repair is the most frequently performed operation worldwide, a small reduction
in loss of workdays can already have significant impact on financial issues. As
for the origin of the pain, it might be the result of local inflammation caused
by the mesh material, but also by nerve entrapment due to fixation techniques.
The development of a new mesh which enables sutureless fixation, Cousin
Biotech® Adhesix*, may overcome pain related to fixation techniques used in the
open hernia repair procedure according to Lichtenstein. Furthermore, the Cousin
Biotech® Adhesix* mesh has already been in use in our institutions and surgeons
familiarized themselves with the application.

We would like to conduct a multicentre randomised controlled clinical trial to
compare the difference in early postoperative pain after unilateral primary
inguinal hernia repair in males. The procedures will be performed in day
surgery. Early postoperative pain is defined as the pain during the first
month, with a special interest in the first two weeks. In addition, we want to
measure the possible benefit in terms of time to return to work, daily
activities, quality of life, operation length, complications and long term
postoperative pain.

Multi-centre, randomised, double blinded, controlled clinical trial.

Surgical inguinal hernia repair, with placement of a surgical mesh.

Inguinal hernia repair at this moment is the most performed operation in
humans. Since this study investigates the differences between two commercially
available and widely used meshes, using the well-known modified Lichtenstein
technique, there are no additional risks besides the standard risk of
complications associated with the open anterior inguinal hernia repair. As an
extra effort, patients will have to fill out a logbook at home during the first
4 weeks and will visit the outpatient clinic at 1 week, 6 weeks and 12 months
after surgery.