Randomised controled trial comparing the effect of a new self-gripping semi-resorbable Parietene Progrip mesh and the sutured Polypropylene mesh on the incidence of chronic inguinodynia in Lichtenstein hernioplasty.

Surgical repair of groin hernias is one of the most commonly performed
operations in the Western world. Use of a prosthetic mesh has become popular
since recurrence, acute and chronic post-operative pain rates are significantly
lower than in autologous repair. In 1984 Lichtenstein popularized routine use
of a polypropylene mesh to create a tension-free hernioplasty, thereby
minimizing postoperative discomfort. This technique has become the gold
standard in open tension-free hernioplasties due to its effectiveness,
easiness, safety and low rate of complications and recurrences. Furthermore it
can be performed under local anaesthesia in a day care setting. However, in the
past years different researches showed that patients who had underwent a
Lichtenstein hernioplasty suffered high rates of post-operative pain en
neuralgia in the groin lasting for months till years. Chronic post-operative
pain has been defined as pain lasting more than 3 months after surgery. The
estimated occurrence of chronic groin pain is 11% with a range from 0%-63% due
to different definitions of pain. More than a quarter of these patients suffers
moderate to severe pain, mostly from a neuropathic origin. According to the
Committee of the International Association for the Study of Pain nociceptive
and neuropathic pain (neuralgia) are initiated or caused by actual or
potential damage of tissue respectively nerves or a dysfunction of the latter.
This damage can be caused by dissection during operation or unnoticed capture
or compression of muscle and nerve fibers by the mesh and the sutures. This
will cause muscle ischaemia or even necrosis and entrapment neuropathy.
Post-operative, complications like inflammation (periostitis, foreign body
reaction to mesh or sutures), wound infection, forrmation of haematoma,
granuloma or seroma can cause damage to and neuroma formation of the sensory
nerves located in the groinregion: ilioinguinal, iliohypogastric,
genitofemoral or lateral femoral cutaneous nerve.
The pain from nerve entrapment or neuroma may arise direct post-operatively or
months after surgery. Once developed the pain will not improve over time since
neuralgia can exists with no continuous nociceptive input. Patients complain of
a burning, numbness or painful sensation in the groin region, testicles, vulva
and/or medial side of the upper leg.
For years it has been common practice in Lichtenstein hernia repair to use a
heavy weight mesh fixed with non-absorbable sutures; the latter to avoid
migration of the mesh which can lead to recurrence of the hernia. However the
above makes clear that although the Lichtenstein hernioplasty is a tension-free
technique, the use of these sutures and mesh cause a high rate of
post-operative pain and neuralgia on the account of a very low recurrence
rate. In the past years there has been looked for alternatives to the sutures
and heavy weight meshes to avoid these problems. Some advocate to use light
weighted meshes. Others recommend reducing the amount of sutures used or
implement non-compressive absorbable devices. This is believed to reduce
pressure neuropathy and to minimize an inflammatory reaction on the mesh and
sutures causing painful adhesives. Other solutions investigated on are the use
of glue, routine neurectomie and laparoscopic hernia repair. In this research a
semi-resorbable self fixing mesh will be investigated. It is presumed that the
semi-resorbable characteristics reduce the amount of foreign body reaction
thereby minimizing damage to the surrounding tissue and nerves. The self fixing
properties are believed to enhance this effect by minimizing entrapment of
muscle and nerve fibres.

The aim was to compare the results of a Lichtenstein hernioplasty using a self
grippng mesh with the classical Lichtenstein repair using a polypropylene
sutured mesh in terms of post-operative and chronic inguinodynia (caused by
nerve irritation, neuralgia, painfull fixation sites) and recurrence. The
hypothesis is that the semi-resorbable self gripping mesh will result in less
chronic inguinodynia in short- and long-term observations without enhancing the
amount of recurrences.

Monocenter dubble blind randomized controlled trial

Lichtenstein hernioplasty using a new self grippng Parietene Progrip Mesh
(group A) compared to a classic haevy weigth polypropylene mesh (group B).

Er zijn geen extra risico's voor de proefpersonen in de onderzoeksgroep. De
verwachte afname van post-operatieve pijnklachten ondervangt het meest
voorkomend nadeel van de standaard behandeling.

Overzicht van tijdstip en inhoud van follow-up:


Parietene Progrip Studie Vragenlijst Lichamelijk onderzoek
Pre-operatief 1 1
Postoperatief:
2 weken
2
1
3 maanden
2
1
12 maanden
2
1
24 maanden 2 1


1= polikliniek; 2 = thuis
Tijdsduur in minuten: pre-operatief 30min, post-operatief 10min