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

Phase 4

Completed

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Lichtenstein mesh; Procedure: PerFix Plug®; Procedure: Prolene® Hernia System

• Registration Number: NCT00580177
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Last Update Submitted: 2007-12-21
• Study First Posted: 2007-12-24
• Last Update Posted: 2007-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 472

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L	Lichtenstein mesh	The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch)
P	PerFix Plug®	The well-konown PerFixPlug technique for inguinal hernia repair.
PHS	Prolene® Hernia System	The well-known Prolene Hernia System method for inguinal hernia repair.

Primary Outcome Measures

Name	Time	Method
Time until full functional recovery	2 weeks, 3 months, 1 year, 3 years
Operation time	Registered after completion of surgery
Pain after operation measured on a VAS-scale and amount of consumed analgesics	Day 1-14, 3 months, 1 year, 3 years after surgery

Secondary Outcome Measures

Name	Time	Method
Complication rate	2 weeks, 3 months, 1 year, 3 years
Aptness for beeing performed under local anaesthesia	During surgery

Trial Locations

Locations (1)

Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital; 🇸🇪 Gothenburg, Vastra Gotalandsregionen, Sweden