PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results (BOOP)

Göteborg University

Status and phase: Completed; Phase 4

Conditions: Hernia, Inguinal

Treatments: Procedure: PerFix Plug®; Procedure: Prolene® Hernia System; Procedure: Lichtenstein mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00580177

FSS BOOP

Details and patient eligibility

About

Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.

Full description

Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.

472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Enrollment: 472 patients

Sex: Male

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30-75 years
• Men
• Primary inguinal hernia
• ASA I-III

Exclusion criteria

• > 75 years
• Females
• ASA IV
• Previous ipsi-lateral hernia surgery
• Drug or alchol abuse
• Severe illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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472 participants in 3 patient groups

L

Active Comparator group

Description:

The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch)

Treatment:

Procedure: Lichtenstein mesh

P

Active Comparator group

Description:

The well-konown PerFixPlug technique for inguinal hernia repair.

Treatment:

Procedure: PerFix Plug®

PHS

Active Comparator group

Description:

The well-known Prolene Hernia System method for inguinal hernia repair.

Treatment:

Procedure: Prolene® Hernia System