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

Jacob Rosenberg

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: no suture; Procedure: suture

Study type: Interventional

Funder types: Other

Identifiers

NCT00815698

CPODenmark001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 334 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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334 participants in 2 patient groups

no suture

Active Comparator group

Description:

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

Treatment:

Procedure: no suture

Suture

Experimental group

Description:

Suture for mesh fixation

Treatment:

Procedure: suture