Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Hernia repair

• Registration Number: NCT01699971
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2009-03
• Study Completion: 2012-03
• Status Verified: 2012-09
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

• 18-75 years
• unilateral primary hernia
• open surgery

Exclusion Criteria

• Recurrent Hernia
• Bilateral Hernia
• laparoscopic surgery
• Female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lichtenstein	Hernia repair	Hernia repair with lichtenstein propylene mesh

Primary Outcome Measures

Name	Time	Method
postoperatively pain	Postoperative 36 month	Visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Quality of life	36 month postoperative	SF36
frequency of recurrencies	postopertive 36 month	check patients journal

Trial Locations

Locations (1)

Ersta Hospital; 🇸🇪 Stockholm, Sweden