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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815698
First Posted: December 30, 2008
Last Update Posted: March 23, 2016
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.
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Jacob Rosenberg, Herlev Hospital:

Primary Outcome Measures:
  • Pain, Numbness and Discomfort in the Groin [ Time Frame: 12 months after surgery ]
    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 ]
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
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): 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:
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
First Submitted: December 29, 2008
First Posted: December 30, 2008
Results First Submitted: March 18, 2015
Results First Posted: March 23, 2016
Last Update Posted: March 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jacob Rosenberg, Herlev Hospital:
pain

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