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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25668
Enrollment
350
Registered
2008-02-15
Start date
2008-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal hernia, mesh, chronic pain Hernia inguinalis, mesh, chronische pijn

Interventions

Inguinal herniorapphy by Lichtenstein technique using Parietene self-fixing semi-resorbable mesh (group A) or standard heavy-weight mesh, Marlex (group B)

Sponsors

MJA Loos MD Department of Surgery Maxima Medical Centre De Run 4600, 5500 MB Veldhoven, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Unilateral primary inguinal hernia

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

MeasureTime frame
Presence of pain (by 6-point Verbal Rating Scale)—

Secondary

MeasureTime frame
- Presence of recurrence - Perioperative and early postoperative complications - Return to daily activities/ work - Quality of life—

Contacts

Public ContactM.J.A. Loos

Maxima Medical Center, Department of Surgery, P.O. Box 7777

+31 (0)40 8888000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)