Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital Identifier:
First received: December 29, 2008
Last updated: February 22, 2016
Last verified: February 2016
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.

Condition Intervention
Inguinal Hernia
Procedure: suture
Procedure: no suture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Pain, Numbness and Discomfort in the Groin [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.

Secondary Outcome Measures:
  • Recurrence [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.

Enrollment: 334
Study Start Date: December 2008
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: no suture
self-adhesive mesh, i.e. no suture for mesh fixation
Procedure: no suture
no suture for mesh fixation, because we use a self-adhesive mesh
Other Name: Progrip mesh
Experimental: Suture
Suture for mesh fixation
Procedure: suture
suture for mesh fixation
Other Name: Prolene and Vicryl sutures

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent hernia
  • Bilateral, scrotal or femoral hernia
  • BMI above 35
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00815698

Bispebjerg Hospital
Copenhagen, Copenhaven, Denmark, 2400
Gentofte Hospital
Gentofte, Hellerup, Denmark, 2900
Nyborg Hospital
Nyborg, Svendborg, Denmark, 5700
Frederikshavn Hospital
Frederikshavn, Denmark, 9900
Randers Hospital
Randers, Denmark, 8930
Sponsors and Collaborators
Jacob Rosenberg
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Principal Investigator: Jacob Rosenberg, MD, DSc Herlev Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jacob Rosenberg, Professor, Herlev Hospital Identifier: NCT00815698     History of Changes
Other Study ID Numbers: CPODenmark001 
Study First Received: December 29, 2008
Results First Received: March 18, 2015
Last Updated: February 22, 2016
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Herlev Hospital:

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal processed this record on October 27, 2016