Slowly-resorbable TIGR® Matrix mesh (Novus Scientific, Uppsala Sweden) for totally extraperitoneal (TEP) endoscopic reinforcement of inguinal-related groin pain.

Groin pain is a common complaint among high-performance athletes. The estimated
occurrence of groin pain in athletes is 5% to 28% and is most seen in hockey
and soccer players, but can also be seen in non-athletes. In some cases there
is no clear pathology that causes this groin pain. In these cases,
inguinal-related groin pain might be present. Inguinal-related groin pain
presents with acute or chronic groin pain to the lower abdominal muscles, pubic
symphysis and adductor musculature which is caused by and exacerbated with
vigorous sport or physical activity.

After other causes of groin pain are excluded by history taking, physical
examination and medical imaging, adequate treatment is important for fast
recovery and resumption of sport activities. Conservative options for treatment
of inguinal-related groin pain consist of physical therapy and rehabilitation
programmes. Other non-operative management strategies are plasma enriched
protein and steroid injections. Surgical treatment should be considered when
conservative treatment has failed. Surgical options include endoscopic totally
extraperitoneal (TEP) procedure with mesh. Promising results in fast resumption
of sport activities after TEP procedure for inguinal-related groin pain are
shown in the literature.

The most frequent used method for TEP procedure is with a non-resorbable mesh.
However, the use of a non-resorbable mesh may cause problems concerning mesh
contractures, chronic postoperative inguinal pain (CPIP) and its inability to
grow with the patient. Although in experience hands the risk of these
complications is low, patients with inguinal-related groin pain are relatively
young and this foreign body will remain in place for life. The
slowly-resorbable TIGR® Matrix mesh will stimulate collagen formation, which
will take over the function of the mesh i.e. reinforcement of the abdominal
wall. Therefore, the advantage of resorbable mesh over non-resorbable mesh is
that the amount of foreign material persisting in the host is reduced, avoiding
potential risks associated with a non-resorbable mesh, but without compromising
the biomechanical resistance of the mesh.

Therefore, we propose a single arm prospective study to evaluateassess the
effectivity, safety and feasibility of the slowly-resorbable TIGR® Matrix mesh
in patients presenting with inguinal-related groin pain undergoing TEP
procedure.

The objective of this study is to collect additional data on the performance
and safety of the slowly-resorbable TIGR® mesh in patients undergoing TEP for
IGRP. The study endpoints are described below.

This study will be designed as a prospective, multicenter, single-arm (cohort)
trial. Patients with inguinal-related groin pain undergoing TEP procedure will
receive slowly-resorbable TIGR® Matrix mesh instead of a non-resorbable mesh.

TEP procedure for inguinal-related groin pain will be performed. During this
procedure a slowly-resorbable TIGR® Matrix mesh will be implanted instead of a
non-resorbable polypropylene mesh, which is used in current standard practice.

Patients/participans with inguinal-related groin pain undergoing TEP procedure
will receive a slowly-resorbable TIGR® Matrix mesh instead of a non-resorbable
mesh.

The potential benefits of this fully resorbable mesh compared to the
non-resorbable meshes are a possible reduced risk of seroma formation,
infection, persistent pain, CPIP and mesh contractures. A higher recurrence
rate may be a potential risk of this product compared to non-resorbable mesh.

During the follow-up, participants will visit the outpatient clinic four times.
During these visits physical investigation will be performed. Also, the
participant will fill in two questionnaires at different times during the
follow-up.