A randomized study comparing Lichtenstein with ProGrip repair for primary inguinal hernias

The Lichtenstein mesh repair for inguinal hernia has become the gold standard
worldwide in the last 2 decades 1. In the traditional operation the mesh
required to repair the posterior inguinal wall is fixed in position with
sutures to prevent migration 2. The widespread adoption of this technique has
reduced the incidence of recurrence to below 5% 3. In contrast the incidence
of persistent post-operative inguinal pain that interferes with daily
activities is 6%. Such chronic pain can be disabling and in half of cases it
leads to depression, time off work and a quarter of patients lose their job as
a result 4. The exact cause of post-herniorrhaphy groin pain is uncertain but
is likely to be related to aspects of the repair technique, including the
handling of the cutaneous nerves, type of mesh used, and the suture-fixation of
the prosthetic material.

For handling of the cutaneous nerves, a systematic review analyzed three
randomized controlled trials regarding ilio-inguinal nerve-handling and found
no difference in outcome in patients receiving either preservation or division
of the nerve 5. Furthermore, two cohort studies suggested better results if
the nerves were identified and therefore protected from accidental or harmful
damage.
For type of mesh, a recent overview of the literature to establish an evidence
base for the use of lightweight meshes found that they have some advantages
with respect to post-operative pain and foreign-body sensation but no advantage
with respect to alleviating severe chronic groin pain 6.
Finally, a cohort study of 80 patients in whom mesh fixation in the
Lichtenstein repair was achieved with fibrin glue in the place of conventional
suture-fixation reported no incidence of chronic groin pain at twelve months7.

A novel concept to achieve secure, sutureless fixation of a lightweight mesh to
the posterior inguinal wall has been achieved by Dr Chastan with the
development of a product achieving Velcro-like adherence to the underlying
tissues8. This self-gripping mesh (Parietene* ProGrip*) is made of lightweight
iso-elastic large pore knitted fabric, monofilament polypropylene incorporating
resorbable micro-hooks that provide a self-gripping property during the first
few months after implantation. Fixation is therefore greatly facilitated
without the requirement for sutures, which can penetrate underlying tissues and
damage cutaneous nerves. The mesh is secured around the spermatic cord with a
self-gripping flap. After resorption of the polylactic acid (PLA) hooks, the
lightweight mesh (40g/m2) ensures long-term posterior inguinal wall
reinforcement.
In a preliminary study, Dr Chastan operated 52 patients corresponding to 70
hernias with good results at one year including no neurological pain or other
complications. Only one patient reported discomfort in his operated groin area
(VAS 1/10) appearing during significant efforts. Due to the simplicity of the
operation, the operating time was only 19 minutes.
These results confirm the interest of low-density self gripping mesh concept.
On this basis, a similar lightweight self gripping mesh composed of
monofilament polyester and PLA micro-hooks has been developed (Parietex*
ProGrip* ).

Evaluation whether the use of the progrip mesh compared to the standard sutured
mesh results in less chronic pain.

At least 600 patients, who fulfill the selection criteria, will be included
worldwide. The technique of hernia repair will be the subject of randomisation:
the standard sutured or progrip mesh. The patients will be follow

Open mesh-based inguinal hernia repair as is the standard procedure for primary
hernia according to the national guidelines. The Lichtenstein encompasses
sutured fixation of the mesh, the progrip mesh is sutureless.

Completing the CRF's is supposed to occupay the patients for 45 mintues in
total.
The risks are supposed to be equal to the standard treatment.