Bard® PolySoft* pre peritoneal mesh versus Parietene* ProGrip* self-fixing semi-resorbable mesh and chronic inguinal pain development.

Bard® PolySoft* pre peritoneal mesh versus Parietene* ProGrip* self-fixing semi-resorbable mesh and chronic inguinal pain development. - SoftGrip Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35542

Enrollment

258

Registered

2010-03-23

Start date

2010-04-14

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

groin hernia inguinal hernia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age of 18 years or older 2. An unilateral primary inguinal hernia. 3. Adequate follow-up possible

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
Objectives: Primary: - Alternation in the painscore on the Visual Analog Scale and the 0-6 point Verbal Descriptor Scale.	—

Secondary

Measure	Time frame
Objectives: Secundary: - Occurrence of hernia inguinalis recurrence objectified by physical examination and/or ultrasound. - Complications; for example recurring haemorrhage and infections - Alternation in the quality of life measured by the SF-36 questionaire.	—

Countries

Netherlands

Outcome results