Objective of the Trial: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?
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objectives:
Primary:
- Alternation in the painscore on the Visual Analog Scale and the 0-6 point
Verbal Descriptor Scale.
Secondary outcome
Objectives:
Secundary:
- Occurrence of hernia inguinalis recurrence objectified by physical
examination and/or ultrasound.
- Complications; for example recurring haemorrhage and infections
- Alternation in the quality of life measured by the SF-36 questionaire.
Background summary
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 surgery1-8. 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-incarcaration and/or
periostitis through incorrectly placed sutures, could be reduced.
Study objective
Objective of the Trial:
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?
Study design
Trial Design:
This study is a double blind randomized controlled trial in patients with a
unilateral primary inguinal hernia. A total of 258 patients will be included
into the entire study and randomized into either ARM A, the control group,
ProGrip* mesh (129 patients), or ARM B, Bard® Polysoft* mesh (129 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.
Study burden and risks
Hypothesis:
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.
W.Brandtlaan 10
6710 HN Ede
Nederland
W.Brandtlaan 10
6710 HN Ede
Nederland
Listed location countries
Age
Inclusion criteria
1. Age of 18 years or older
2. An unilateral primary inguinal hernia.
3. Adequate follow-up possible
Exclusion criteria
1. Incarcerated inguinal hernia
2. Recurrent inguinal hernia
3. Local inguinal inflammation
4. Concurrent femoral hernia
5. ASA 4 or more
6. Adequate follow-up impossible
7. Previous inguinal surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24683.041.09 |