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

Göteborg University472 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

472

Conditions

Hernia, Inguinal

Interventions

Lichtenstein meshPROCEDURE

The different techniques are compared and evaluated according to primary and secondary objectives.

PerFix Plug®PROCEDURE

The different techniques are compared and evaluated according to primary and secondary objectives.

Prolene® Hernia SystemPROCEDURE

The different techniques are compared and evaluated according to primary and secondary objectives.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital

Gothenburg, Vastra Gotalandsregionen, Sweden

Outcomes

Primary Outcomes

Time until full functional recovery

Time frame: 2 weeks, 3 months, 1 year, 3 years

Operation time

Time frame: Registered after completion of surgery

Pain after operation measured on a VAS-scale and amount of consumed analgesics

Time frame: Day 1-14, 3 months, 1 year, 3 years after surgery

Secondary Outcomes

Complication rate

Time frame: 2 weeks, 3 months, 1 year, 3 years

Aptness for beeing performed under local anaesthesia

Time frame: During surgery

Data from ClinicalTrials.gov

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