The effect of two anterior approaches to inguinal hernia repair, pre peritoneal Bard® Polysoft™ self expanding patch versus a ProGrip self-fixing semi-resorbable mesh, on the development of acute and chronic inguinal pain.

Background:

With the introduction of prosthesis material, the Lichtenstein technique has reduced the recurrence rate after inguinal hernia surgery to an acceptable level (2%). Polypropylene mesh is the first choice prosthesis material in most Dutch hospitals.

However, chronic pain after inguinal hernia surgery remains a problem. A number of studies demonstrated that 20 – 40% of patients experience chronic pain after elective inguinal hernia surgery. This is due to the occurrence of extensive fibrosis that is induced by a standard polypropylene mesh, although the method of fixation, with non-resolvable stitches, might also play a role in the pathogenesis of chronic pain.

Therefore two new types of mesh prostheses have been developed to prevent the occurrence of chronic pain. The first type is self-adhesive and light-weight, the second is self-fixing and has the advantage of a preperitoneal correction through an open anterior approach.
In theory this could possibly prevent chronic pain on both pathogenesis pathways.

Both the extent of fibrosis, as the chance of nerve-incarceration and/or periostitis through incorrectly placed sutures, could be reduced.



Objective of the Trial:

Primary: Does the use of a Bard® Polysoft™ preperitoneal mesh result in less chronic pain than after the use of a ProGrip™self-fixing semi-resorbable mesh for patients with an inguinal hernia repair through an anterior approach?

Secondary:

1. Does the use of Bard® Polysoft™ mesh result in a different recurrence rate than the use of a ProGrip™ mesh?

2. Does the use of a Bard® Polysoft™ mesh attend with less peri- and early postoperative complications than the use of a ProGrip™ mesh?

3. Does the use of a Bard® Polysoft™ mesh result in a faster resumption of work than the use of a ProGrip™ mesh?

4. Does the use of a Bard® Polysoft™ mesh result in a higher quality of life than the use of a ProGrip™ mesh.



Trial Design:

This study is a double blind randomized controlled trial in patients with a unilateral primary inguinal hernia. A total of 460 patients will be included into the entire study and randomized into either ARM A, the control group, ProGrip™ mesh (230 patients). or ARM B, Bard® Polysoft™ mesh (230 patients) The Bard® Polysoft™ mesh will be placed preperitoneal, whilst the ProGrip mesh will be placed according to the Lichtenstein technique. In both groups correction will be performed through an anterior approach.



Follow-up:

Patients will be followed-up for at least one year. At 2, 12 weeks and 12 months the following factors will be registrated: pain, inguinal hernia recurrence, occurrence of complications, quality of life and work resume.

Compared to a ProGrip self-fixing semi-resorbable mesh the use of a Bard® Polysoft™ preperitoneal mesh results in less chronic groin pain in inguinal herniorrhaphy patients.

1. 2 weeks;

2. 12 weeks;

3. 12 months;

4. Possibly 5 years.

Inguinal herniorrhaphy by using the ProGrip™ self-fixing semi-resorbable mesh (group A) or the Bard® Polysoft™ preperitoneal mesh (group B).