Randomised controled trial comparing the effect of a new self-gripping semi-resorbable Parietene Progrip mesh and the sutured Polypropylene mesh on the incidence of chronic inguinodynia in Lichtenstein hernioplasty.

Randomised controled trial comparing the effect of a new self-gripping semi-resorbable Parietene Progrip mesh and the sutured Polypropylene mesh on the incidence of chronic inguinodynia in Lichtenstein hernioplasty. - Inguinodynia after Lichtenstein: Polypropylene versus Parietene Progrip

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33251

Enrollment

400

Registered

2009-12-24

Start date

2010-07-25

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

groin hernia hernia inguinalis

Interventions

Lichtenstein hernioplasty using a new self grippng Parietene Progrip Mesh (group A) compared to a classic haevy weigth polypropylene mesh (group B).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Capacitated male person, age 18 years or older 2. Unilateral inguinal hernia

Exclusion criteria

Exclusion criteria: 1. Concurrent femoral hernia 2. Incarcerated inguinal hernia 3. ASA 4 or more 4. Adequate follow up impossible because of mental retardation, dementia, foreign language speaker.

Design outcomes

Primary

Measure	Time frame
1. Amount of post-operative and chronic nociceptive and neuropathic groin pain. 2. Recurrence rate	—

Secondary

Measure	Time frame
1. Peroperative and post-operative complications like infection, formation of haematoma or seroma. 2. Operating time 3. Costs 4. Easiness of use 5. Return to work and daily activities 6. quality of life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)