Effectiveness of total extraperitoneal hernia correction for clinically occult inguinal hernia: a multicenter randomized controlled trial

Groin pain is a frequent complaint in surgical practice, with an inguinal
hernia being at the top of the differential diagnosis. Correction of an
inguinal hernia is the most commonly performed elective surgical intervention
worlwide with an estimated 30.000 procedures in the Netherlands annually. In
the majority of cases an inguinal hernia is a clinical diagnosis based on the
classical presentation of a reducible groin swelling with a positive cough
impulse sometimes accompanied with pain. However, patients presenting with
groin pain without signs of an inguinal hernia provide a diagnostic challenge.
Other frequently seen causes of groin pain are, for example, of myogenic,
neurogenic or osseous origin. If ultrasonography, which most often is the first
additional imaging modality to be ordered, shows an inguinal hernia that could
not be diagnosed clinically, the radiological hernia is called a clinically
occult groin hernia. In accordance with the current guidelines (European Hernia
Society), radiologic presence of an inguinal hernia often leads to surgical
intervention. However, in daily practice, correction of a clinically occult
groin hernia often does not lead to pain relief. It is plausible that when a
radiologic finding of an inguinal hernia is present, the hernia is not the
actual cause of groin pain in all case, and another cause for the pain may
exist. Hence, not all patients with a clinically occult hernia will benefit
from surgical intervention. Until now, no clinical studies have been performing
focussing on the effect of an inguinal hernia correctoin on the course of pain
in patients with a clinically occult groin hernia.
Would this study demonstrate a watchful waiting approach is non-inferior to a
TEP inguinal hernia correction, unnecessary surgery can be avoided, wich will
lead to a higher health care efficiency and higher cost-effectiveness.

To evealuate the (cost-)effectiveness of endoscopic totally extraperitoneal
(TEP) inguinal hernia correction comparecd to watchful waiting in patients with
groin pain and a clinically occult inguinal hernia.

The study design is a multicenter non-blinded randomized controlled
non-inferiority trial.

The intervention to be evaluated in this study is the endoscopic total
extraperitoneal (TEP) inguinal hernia correction.

All the participants will undergo physical examination on their first visit to
the outpatient clinic. If they decide to participate in the trial , they will
be asked to fill out pre-operative questionnaires before start of treatment.
They will be asked to fill out additional questionnaires the following
moments: After 1.5, 3, 6 and 12 months from start of treatment. Three and 12
months after treatment additional visits to the outpatient clinic will be
scheduled where they will undergo physical examination. There are no additional
risks related to this trial.