Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

NCT ID: NCT00815698

Last Updated: 2016-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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no suture

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

Group Type ACTIVE_COMPARATOR

no suture

Intervention Type PROCEDURE

no suture for mesh fixation, because we use a self-adhesive mesh

Suture

Suture for mesh fixation

Group Type EXPERIMENTAL

suture

Intervention Type PROCEDURE

suture for mesh fixation

Interventions

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suture

suture for mesh fixation

Intervention Type PROCEDURE

no suture

no suture for mesh fixation, because we use a self-adhesive mesh

Intervention Type PROCEDURE

Other Intervention Names

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Prolene and Vicryl sutures Progrip mesh

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Recurrent hernia
* Bilateral, scrotal or femoral hernia
* BMI above 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Frederikshavn Hospital

UNKNOWN

Sponsor Role collaborator

Nyborg Hospital

UNKNOWN

Sponsor Role collaborator

Jacob Rosenberg

OTHER

Sponsor Role lead

Responsible Party

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Jacob Rosenberg

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jacob Rosenberg, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Copenhaven, Denmark

Site Status

Frederikshavn Hospital

Frederikshavn, Frederikshavn, Denmark

Site Status

Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Site Status

Randers Hospital

Randers, Randers, Denmark

Site Status

Nyborg Hospital

Nyborg, Svendborg, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 23203909 (View on PubMed)

Rosenberg J, Henriksen NA, Jorgensen LN. Multicenter data acquisition made easy. Trials. 2010 Apr 30;11:49. doi: 10.1186/1745-6215-11-49.

Reference Type DERIVED
PMID: 20433715 (View on PubMed)

Other Identifiers

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CPODenmark001

Identifier Type: -

Identifier Source: org_study_id

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