NCT00815698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 23, 2016

Completed
Last Updated

March 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

December 29, 2008

Results QC Date

March 18, 2015

Last Update Submit

February 22, 2016

Conditions

Inguinal Hernia

Keywords

pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months after surgery

Secondary Outcomes (1)

  • Recurrence

    12 months after surgery

Study Arms (2)

no suture

ACTIVE COMPARATOR

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

Procedure: no suture

Suture

EXPERIMENTAL

Suture for mesh fixation

Procedure: suture

Interventions

suturePROCEDURE

suture for mesh fixation

Also known as: Prolene and Vicryl sutures
Suture
no suturePROCEDURE

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

Also known as: Progrip mesh
no suture

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bispebjerg Hospital

Copenhagen, Copenhaven, 2400, Denmark

Location

Frederikshavn Hospital

Frederikshavn, Frederikshavn, 9900, Denmark

Location

Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

Randers Hospital

Randers, Randers, 8930, Denmark

Location

Nyborg Hospital

Nyborg, Svendborg, 5700, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 23203909RESULT

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

    PMID: 20433715DERIVED

MeSH Terms

Conditions

Hernia, InguinalPain

Interventions

SuturesPolypropylenes

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and SuppliesPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Jacob Rosenberg
Organization
Herlev Hospital, dept. of Surgery
jacob.rosenberg@regionh.dk
+45 26237323

Study Officials

  • Jacob Rosenberg, MD, DSc

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2011

Study Completion

September 1, 2011

Last Updated

March 23, 2016

Results First Posted

March 23, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)