search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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.


- candidate number6351
- NTR NumberNTR1965
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2009
- Secondary IDs09-162 METC number
- Public TitleThe 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.
- Scientific TitleBard® PolySoft™ pre peritoneal mesh versus Parietene™ ProGrip™ self-fixing semi-resorbable mesh and chronic inguinal pain development. A double blind randomized controlled trial.
- ACRONYMSoftGrip Trial
- hypothesisCompared 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.
- Healt Condition(s) or Problem(s) studiedHernia inguinal, Pain, Mesh, Chronic
- Inclusion criteria1. Age of 18 years or older;
2. A unilateral primary inguinal hernia;
3. Adequate follow-up possible.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-jan-2009
- planned closingdate5-jan-2012
- Target number of participants460
- InterventionsInguinal herniorrhaphy by using the ProGrip™ self-fixing semi-resorbable mesh (group A) or the Bard® Polysoft™ preperitoneal mesh (group B).
- Primary outcomeDoes the use of Bard® Polysoft™ preperitoneal mesh result in less chronic groin pain than the use of the ProGrip™ self-fixing semi-resorbable mesh in inguinal herniorrhaphy patients?
- Secondary outcome1. Presence of recurrence;
2. Perioperative and early postoperative complications;
3. Return to daily activities/ work;
4. Quality of life.
- Timepoints1. 2 weeks;
2. 12 weeks;
3. 12 months;
4. Possibly 5 years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. D. Čadanová
- CONTACT for SCIENTIFIC QUERIESPhd. MD. R.M.H.G. Mollen
- Sponsor/Initiator Ziekenhuis Gelderse Vallei, Department of General Surgery
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuis Gelderse Vallei, Department of General Surgery
- PublicationsN/A
- Brief summaryBackground:
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.
- Main changes (audit trail)
- RECORD25-aug-2009 - 12-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl