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

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ClinicalTrials.gov Identifier: NCT00815698
Recruitment Status : Completed
First Posted : December 30, 2008
Results First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Inguinal Hernia Procedure: suture Procedure: no suture Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

Publications of Results:
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 Posted: December 30, 2008    Key Record Dates
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