Glubran Mesh Fixation in Lichtenstein Hernioplasty (Cyanoacr)

Kuopio University Hospital

Status and phase: Completed; Phase 2

Conditions: Inguinal Hernia

Treatments: Procedure: cyanoacrylate glue

Study type: Interventional

Funder types: Other

Identifiers

NCT00659542

cyanoacrylate1

KUH5204518

Details and patient eligibility

About

The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

Full description

Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• inguinal hernia
• adult patient

Exclusion criteria

• patient not willing
• multiple recurrences
• inguinal pain without evidence of hernia
• femoral hernia
• large scrotal hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

1

No Intervention group

Description:

mesh fixation by absorbable sutures

2

Experimental group

Description:

mesh fixation by cyanoacrylate glue

Treatment:

Procedure: cyanoacrylate glue