Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

Randomized Controlled Study Comparing Three Different Techniques for Open

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 Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Hernia repair; Procedure: Hernia repair; Procedure: Hernia repair

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 116 91
    • Ersta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Recurrent Hernia
• Bilateral Hernia
• laparoscopic surgery
• Female

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lichtenstein; Hernia repair with lichtenstein propylene mesh	Procedure: Hernia repair; Hernia repair admodum Lichtenstein with polypropylene mesh; Procedure: Hernia repair; Hernia repair with Ultra Pro Hernia System (UHS); Procedure: Hernia repair; Hernia repair with Prolene Hernia System(PHS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperatively pain	Visual analog scale (VAS)	Postoperative 36 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	SF36	36 month postoperative
frequency of recurrencies	check patients journal	postopertive 36 month

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 2006/672-31/4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No