The effect of two anterior approaches to inguinal hernia repair, pre peritoneal Bard® Polysoft™ self expanding patch versus a ProGrip self-fixing semi-resorbable mesh, on the development of acute and chronic inguinal pain.

Bard® PolySoft™ pre peritoneal mesh versus Parietene™ ProGrip™ self-fixing semi-resorbable mesh and chronic inguinal pain development. A double blind randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24826

Enrollment

460

Registered

2009-08-25

Start date

2009-01-05

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, chronic pain, mesh

Interventions

Inguinal herniorrhaphy by using the ProGrip™ self-fixing semi-resorbable mesh (group A) or the Bard® Polysoft™ preperitoneal mesh (group B).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of 18 years or older; 2. A 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
Does the use of Bard® Polysoft™ preperitoneal mesh result in less chronic groin pain than the use of the ProGrip™ self-fixing semi-resorbable mesh in inguinal herniorrhaphy patients?	—

Secondary

Measure	Time frame
1. Presence of recurrence; 2. Perioperative and early postoperative complications; 3. Return to daily activities/ work; 4. Quality of life.	—

Contacts

Public ContactD. Čadanová

Department of General Surgery, Ziekenhuis Gelderse Vallei, Willy Brandtlaan 10

dominikacadanova@hotmail.com+31-318-434343

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)