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

February 22, 2016 updated by: Jacob Rosenberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederikshavn, Denmark, 9900
        • Frederikshavn Hospital
      • Randers, Denmark, 8930
        • Randers Hospital
    • Copenhaven
      • Copenhagen, Copenhaven, Denmark, 2400
        • Bispebjerg Hospital
    • Hellerup
      • Gentofte, Hellerup, Denmark, 2900
        • Gentofte Hospital
    • Svendborg
      • Nyborg, Svendborg, Denmark, 5700
        • Nyborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent hernia
  • Bilateral, scrotal or femoral hernia
  • BMI above 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Progrip mesh
Experimental: Suture
Suture for mesh fixation
Procedure: suture
suture for mesh fixation
Other Names:
  • Prolene and Vicryl sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacob Rosenberg

Collaborators

Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital

Investigators

  • Principal Investigator: Jacob Rosenberg, MD, DSc, Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 29, 2008

First Submitted That Met QC Criteria

December 29, 2008

First Posted (Estimate)

December 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPODenmark001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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