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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
October 1, 2012
October 4, 2012
October 4, 2012
October 2006
March 2009   (Final data collection date for primary outcome measure)
postoperatively pain [ Time Frame: Postoperative 36 month ]
Visual analog scale (VAS)
Same as current
No Changes Posted
  • Quality of life [ Time Frame: 36 month postoperative ]
    SF36
  • frequency of recurrencies [ Time Frame: postopertive 36 month ]
    check patients journal
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Inguinal Hernia
  • 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)
Active Comparator: Lichtenstein
Hernia repair with lichtenstein propylene mesh
Interventions:
  • Procedure: Hernia repair
  • Procedure: Hernia repair
  • Procedure: Hernia repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
March 2012
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent Hernia
  • Bilateral Hernia
  • laparoscopic surgery
  • Female
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01699971
2006/672-31/4
No
Not Provided
Not Provided
Anders Thorell, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Anders Thorell, Assoc Prof Karolinska Institutet
Karolinska Institutet
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP