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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
suture
no suture
Sponsored by
Jacob Rosenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Bispebjerg Hospital
  • Gentofte Hospital
  • Nyborg Hospital
  • Frederikshavn Hospital
  • Randers Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

no suture

Suture

Arm Description

self-adhesive mesh, i.e. no suture for mesh fixation

Suture for mesh fixation

Outcomes

Primary Outcome Measures

Pain, Numbness and Discomfort in the Groin
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
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.

Full Information

First Posted
December 29, 2008
Last Updated
February 22, 2016
Sponsor
Jacob Rosenberg
Collaborators
Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Frederikshavn Hospital, Nyborg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00815698
Brief Title
Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair
Acronym
Dangrip
Official Title
Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob Rosenberg
Collaborators
Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Frederikshavn Hospital, Nyborg Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no suture
Arm Type
Active Comparator
Arm Description
self-adhesive mesh, i.e. no suture for mesh fixation
Arm Title
Suture
Arm Type
Experimental
Arm Description
Suture for mesh fixation
Intervention Type
Procedure
Intervention Name(s)
suture
Other Intervention Name(s)
Prolene and Vicryl sutures
Intervention Description
suture for mesh fixation
Intervention Type
Procedure
Intervention Name(s)
no suture
Other Intervention Name(s)
Progrip mesh
Intervention Description
no suture for mesh fixation, because we use a self-adhesive mesh
Primary Outcome Measure Information:
Title
Pain, Numbness and Discomfort in the Groin
Description
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.
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Recurrence
Description
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.
Time Frame
12 months after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy males 18-80 years Primary inguinal unilateral hernia Exclusion Criteria: Recurrent hernia Bilateral, scrotal or femoral hernia BMI above 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, MD, DSc
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhaven
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Gentofte Hospital
City
Gentofte
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Nyborg Hospital
City
Nyborg
State/Province
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Frederikshavn Hospital
City
Frederikshavn
ZIP/Postal Code
9900
Country
Denmark
Facility Name
Randers Hospital
City
Randers
ZIP/Postal Code
8930
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23203909
Citation
Jorgensen LN, Sommer T, Assaadzadeh S, Strand L, Dorfelt A, Hensler M, Rosenberg J; Danish Multicentre DANGRIP Study Group. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg. 2013 Mar;100(4):474-81. doi: 10.1002/bjs.9006. Epub 2012 Nov 30.
Results Reference
result
PubMed Identifier
20433715
Citation
Rosenberg J, Henriksen NA, Jorgensen LN. Multicenter data acquisition made easy. Trials. 2010 Apr 30;11:49. doi: 10.1186/1745-6215-11-49.
Results Reference
derived

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Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

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