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
  Purpose

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 ]

Secondary Outcome Measures:
  • recurrence, satisfaction and quality of life [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00815698

Locations
Denmark
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
Investigators
Principal Investigator: Jacob Rosenberg, MD, DSc Herlev Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacob Rosenberg, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00815698     History of Changes
Other Study ID Numbers: CPODenmark001
Study First Received: December 29, 2008
Last Updated: March 27, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
pain

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

ClinicalTrials.gov processed this record on July 20, 2014