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The effect of Parietene self-fixing semi-resorbable mesh on inguinal pain development


- candidate number3031
- NTR NumberNTR1212
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-feb-2008
- Secondary IDs0752 METC nummer
- Public TitleThe effect of Parietene self-fixing semi-resorbable mesh on inguinal pain development
- Scientific TitleA double-blind randomized controlled trial comparing the effect of using Parietene self-fixing semi-Resorbable mesh with standard heavy-weight polypropylene mesh on inguinal pain development following inguinal herniorrhaphy
- ACRONYMPARADE trial
- hypothesisCompared to a standard heavy-weight mesh, the Parietene self-fixing semi-resorbable mesh results in less chronic inguinal pain following inguinal herniorrhaphy
- Healt Condition(s) or Problem(s) studiedHernia inguinal, Chronic pain, Mesh
- Inclusion criteria1. Age 18 years or older
2. Unilateral primary inguinal hernia
- Exclusion criteria1. Incarcerated inguinal hernia
2. Local inguinal inflammation
3.Concurrent femoral hernia
4. ASA 4 or more
5. Preexistent chronic inguinal pain due to previous inguinal operations like vasectomy, Pfannenstiel incision or open appendectomy
6. Adequate follow up impossible: mental retardation, dementia, foreign language speaker, living in asylumseekers centre
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-sep-2012
- Target number of participants350
- InterventionsInguinal herniorapphy by Lichtenstein technique using Parietene self-fixing semi-resorbable mesh (group A) or standard heavy-weight mesh, Marlex (group B)
- Primary outcomePresence of pain (by 6-point Verbal Rating Scale)
- Secondary outcome- Presence of recurrence
- Perioperative and early postoperative complications
- Return to daily activities/ work
- Quality of life
- Timepoints3 weeks
3 months
12 months
36 months
- Trial web sitewww.paradetrial.com
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs M.J.A. Loos
- CONTACT for SCIENTIFIC QUERIESDr. R.M.H. Roumen
- Sponsor/Initiator Maxima Medical Center, Department of General Surgery
- Funding
(Source(s) of Monetary or Material Support)
Covidien Nederland
- PublicationsN/A
- Brief summaryPARADE trial A double-blind randomized controlled trial comparing the effect of using PArietene self-fixing semi-Resorbable mesh with standard heavy-weight polypropylene mesh on inguinal pain development following inguinal herniorrhaphy Introduction: The introduction of prosthetic materials has drastically reduced recurrence rates in inguinal hernia surgery. However, chronic postherniorrhaphy pain (‘inguinodynia’) may occur in up to 40% of patients. Careful analysis has identified neuropathic pain caused by damaged and entrapped nerves as a major contributor to inguinodynia. Both surgical technique as well as characteristics of implanted materials may contribute to pain. Moreover, a fibrotic response created by a proper hernioplasty may also result in painful nerve entrapments. The technique of suturing the mesh may be an additional factor as nerve tissue and periostal layers of the pubic bone are 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. Study hypothesis: A lightweight self-fixing mesh (Parietene®; Tyco-Sofradim) results in less chronic pain compared to a standard polypropylene mesh (Marlex®; Bard) using the Lichtenstein technique. Study design: Singlecentre double blind randomized controlled trial (Máxima Medical Centre, Eindhoven/ Veldhoven The Netherlands) Patients: Patients with a primary unilateral inguinal hernia. Total number of patients: 350 (Parietene n=175, Marlex n=175). Inclusion period: 1.5 year. Outcome measures: Primary: Chronic pain (6-point Verbal Rating Scale) Secondary: Recurring inguinal hernia, direct postoperative complications, return to work or daily activities, quality of life (SF-36) Follow up: At 3 weeks, 3 months, 12 months and 3 years. First results for publication at 3 months (October 2009)
- Main changes (audit trail)
- RECORD24-jan-2008 - 13-mrt-2008


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