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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: Lichtenstein mesh
* Procedure: PerFix Plug®
* Procedure: Prolene® Hernia System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L<br>The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch) | Procedure: Lichtenstein mesh<br>* The different techniques are compared and evaluated according to primary and secondary objectives.<br>* Other names: Inguinal hernioplasty (surgical repair of inguinal hernia);|
| Active Comparator: P<br>The well-konown PerFixPlug technique for inguinal hernia repair. | Procedure: PerFix Plug®<br>* The different techniques are compared and evaluated according to primary and secondary objectives.<br>* Other names: Inguinal hernioplasty (surgical repair of inguinal hernia);|
| Active Comparator: PHS<br>The well-known Prolene Hernia System method for inguinal hernia repair. | Procedure: Prolene® Hernia System<br>* The different techniques are compared and evaluated according to primary and secondary objectives.<br>* Other names: Inguinal hernioplasty (surgical repair of inguinal hernia);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | 2 weeks, 3 months, 1 year, 3 years | 
| Aptness for beeing performed under local anaesthesia |  | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, Randomized controlled trial, Surgery, Complications, Surgical mesh