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Glubran Mesh Fixation in Lichtenstein Hernioplasty

Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00659542
Acronym
Cyanoacr
Enrollment
300
Registered
2008-04-16
Start date
2007-10-31
Completion date
2009-12-31
Last updated
2010-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

inguinal hernia, inguinal hernioplasty, mesh fixation, Lichtenstein hernioplasty

Brief summary

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.

Detailed 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.

Interventions

1 ml glue

Sponsors

North Karelia Central Hospital
CollaboratorOTHER
Paijat-Hame Hospital District
CollaboratorOTHER
Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* inguinal hernia * adult patient

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
postoperative pain1 year

Secondary

MeasureTime frame
hernia recurrence, quality of life1 year

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026