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Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699971
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
  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 (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study Comparing Three Different Techniques for Open

Resource links provided by NLM:


Further study details as provided by Anders Thorell, Karolinska Institutet:

Primary Outcome Measures:
  • postoperatively pain [ Time Frame: Postoperative 36 month ]
    Visual analog scale (VAS)


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 36 month postoperative ]
    SF36

  • frequency of recurrencies [ Time Frame: postopertive 36 month ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Anders Thorell, Assoc prof, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01699971     History of Changes
Other Study ID Numbers: 2006/672-31/4
First Submitted: October 1, 2012
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: September 2012

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