Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

Karolinska Institutet160 enrolled

Overview

The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Inguinal Hernia

Interventions

Hernia repairPROCEDURE

Hernia repair admodum Lichtenstein with polypropylene mesh

Hernia repairPROCEDURE

Hernia repair with Ultra Pro Hernia System (UHS)

Hernia repairPROCEDURE

Hernia repair with Prolene Hernia System(PHS)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-75 years * unilateral primary hernia * open surgery Exclusion Criteria: * Recurrent Hernia * Bilateral Hernia * laparoscopic surgery * Female

Locations (1)

Ersta Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

postoperatively pain

Visual analog scale (VAS)

Time frame: Postoperative 36 month

Secondary Outcomes

Quality of life

SF36

Time frame: 36 month postoperative

frequency of recurrencies

check patients journal

Time frame: postopertive 36 month

Data from ClinicalTrials.gov

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