A double-blind randomized controlled trial comparing PArietene self-fixing semi-Resorbable mesh with standard heavy-weight polypropylene mesh on chronic inguinal pAin DEvelopment

Recurrence rates in inguinal surgery have been drastically reduced with the
introduction of prosthetic materials. However, with incidence rates ranging
from 20 to 40% chronic postherniorrhaphy inguinodynia remains a worrisome
complication. Careful analysis has identified neuropathic pain caused by
damaged and entrapped nerves as a major contributor. Both surgical technique as
implanted materials could be withheld responsible. Although, the induced
fibrotic response creates a proper hernioplasty, it can result in a painful
nerve entrapment as well. Another possible pain initiator can be found in
suturing the mesh, since nerve tissue and periostal layers of the pubic bone
may be grapped along with other tissues. To prevent such painful sequelae a new
type of mesh has been developed which exhibits both semi-resorbable and
self-fixing properties. Less fibrotic tissue reaction combined with sutureless
implantation may result in less chronic pain following inguinal hernia repair.

Primary:
Does the implementation of a Parietene® self-fixing semi-resorbable mesh
(Covidien-Sofradim) result in less chronic inguinal pain as compared to a
standard polypropylene mesh (Marlex®; Bard) in the treatment of a inguinal
hernia using the Lichtenstein technique?

Secondary:
1. Does the implementation of a Parietene® self-fixing semi-resorbable mesh
(Covidien-Sofradim) result in a different recurrence rate as compared to a
standard polypropylene mesh (Marlex®; Bard) in the treatment of a inguinal
hernia using the Lichtenstein technique.?
2. Does the implementation of a Parietene® self-fixing semi-resorbable mesh
(Covidien-Sofradim) result in less peri- and early postoperative complicaties
as compared to a standard polypropylene mesh (Marlex®; Bard) in the treatment
of a inguinal hernia using the Lichtenstein technique?
3. Does the implementation of a Parietene® self-fixing semi-resorbable mesh
(Covidien-Sofradim) result in an earlier return to daily activities as compared
to a standard polypropylene mesh (Marlex®; Bard) in the treatment of a inguinal
hernia using the Lichtenstein technique?
4. Does the implementation of a Parietene® self-fixing semi-resorbable mesh
(Covidien-Sofradim) result in a better quality of life as compared to a
standard polypropylene mesh (Marlex®; Bard) in the treatment of a inguinal
hernia using the Lichtenstein technique?

Monocentric double-blind randomized controlled trial
(Máxima Medical Centre, Eindhoven/ Veldhoven The Netherlands)

In the studygroup the Parietene lightweight self-fixing mesh (Tyco-Sofradim) is
used. In the controlgroup a standard polypropylene mesh is used. both groups
are treated according to the Lichtenstein technique.

There are no known side-effects of the Parietene® self-fixing semi-resorbable
mesh. In theory, the lightweight en self-fixing qualities of the mesh may
result in a higher recurrence rate. Possible short-term complications of the
inguinal hernia repair itself, are bleeding, seroma formation and wound
infecton.