A double-blind randomized controlled trial comparing PArietene self-fixing semi-Resorbable mesh with standard heavy-weight polypropylene mesh on chronic inguinal pAin DEvelopment

A double-blind randomized controlled trial comparing PArietene self-fixing semi-Resorbable mesh with standard heavy-weight polypropylene mesh on chronic inguinal pAin DEvelopment - PARADE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31651

Enrollment

350

Registered

2008-03-14

Start date

2008-04-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Chronic pain after inguinal hernia repair

Interventions

In the studygroup the Parietene lightweight self-fixing mesh (Tyco-Sofradim) is used. In the controlgroup a standard polypropylene mesh is used. both groups are treated according to the Lichtenstein

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Primary unilateral inguinal hernia 2. Age: * 18 years old

Exclusion criteria

Exclusion criteria: 1. Signs of incarceration 2. Signs of local infection 3. Presence of chronic inguinal pain following a previous vasectomy, Pfannenstiel incision, appendectomy 4. ASA IV 5. Adequate follow up not possible: mental retardation, dementia, foreign language, living in asylum seekers centre

Design outcomes

Primary

Measure	Time frame
Pain assessment (6-point Verbal Rating Scale and Surgical Pain Scales)	—

Secondary

Measure	Time frame
Recurring inguinal hernia (physical examination/ ultrasonography), peri- and early postoperative complications (questionnaire), return to daily actvities (questionnaire), quality of life (SF-36)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)