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Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01699971
First received: October 1, 2012
Last updated: October 3, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Inguinal Hernia
 Procedure: Hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study Comparing Three Different Techniques for Open

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • postoperatively pain [ Time Frame: Postoperative 36 month ] [ Designated as safety issue: No ]
    Visual analog scale (VAS)


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 36 month postoperative ] [ Designated as safety issue: No ]
    SF36

  • frequency of recurrencies [ Time Frame: postopertive 36 month ] [ Designated as safety issue: No ]
    check patients journal


Enrollment: 160
Study Start Date: October 2006
Study Completion Date: March 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent Hernia
  • Bilateral Hernia
  • laparoscopic surgery
  • Female
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699971

Locations
Sweden
Ersta Hospital
Stockholm, Sweden, 116 91
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
  More Information

No publications provided

Responsible Party: Anders Thorell, Assoc prof, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01699971     History of Changes
Other Study ID Numbers: 2006/672-31/4
Study First Received: October 1, 2012
Last Updated: October 3, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 21, 2013