Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

Inguinal Hernia Clinical Trial

— Dangrip  

Official title:

Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815698
• Other study ID #: CPODenmark001
• Status: Completed
• Phase: N/A
• First received: December 29, 2008
• Last updated: March 27, 2013
• Start date: December 2008
• Est. completion date: September 2011

Study information

• Verified date: March 2013
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy males 18-80 years

• Primary inguinal unilateral hernia

Exclusion Criteria:

• Recurrent hernia

• Bilateral, scrotal or femoral hernia

• BMI above 35

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Copenhaven
Denmark	Frederikshavn Hospital	Frederikshavn
Denmark	Gentofte Hospital	Gentofte	Hellerup
Denmark	Nyborg Hospital	Nyborg	Svendborg
Denmark	Randers Hospital	Randers

Sponsors (5)

Lead Sponsor	Collaborator
Jacob Rosenberg	Bispebjerg Hospital, Frederikshavn Hospital, Nyborg Hospital, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain, numbness and discomfort in the groin		12 months after surgery	No
Secondary	recurrence, satisfaction and quality of life		12 months after surgery	No