Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair (Dangrip)

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00815698
First received: December 29, 2008
Last updated: March 27, 2013
Last verified: March 2013

December 29, 2008
March 27, 2013
December 2008
April 2011   (final data collection date for primary outcome measure)
pain, numbness and discomfort in the groin [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00815698 on ClinicalTrials.gov Archive Site
recurrence, satisfaction and quality of life [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair
Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial

The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.

Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia
  • Procedure: suture
    suture for mesh fixation
    Other Name: Prolene and Vicryl sutures
  • Procedure: no suture
    no suture for mesh fixation, because we use a self-adhesive mesh
    Other Name: Progrip mesh
  • Active Comparator: no suture
    self-adhesive mesh, i.e. no suture for mesh fixation
    Intervention: Procedure: no suture
  • Experimental: Suture
    Suture for mesh fixation
    Intervention: Procedure: suture

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
September 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males 18-80 years
  • Primary inguinal unilateral hernia

Exclusion Criteria:

  • Recurrent hernia
  • Bilateral, scrotal or femoral hernia
  • BMI above 35
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00815698
CPODenmark001
No
Jacob Rosenberg, Herlev Hospital
Jacob Rosenberg
  • Bispebjerg Hospital
  • University Hospital, Gentofte, Copenhagen
  • Frederikshavn Hospital
  • Nyborg Hospital
Principal Investigator: Jacob Rosenberg, MD, DSc Herlev Hospital
Herlev Hospital
March 2013

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