Glubran Mesh Fixation in Lichtenstein Hernioplasty

Inguinal Hernia Clinical Trial

— Cyanoacr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659542
• Other study ID #: KUH5204518
• Secondary ID: cyanoacrylate1
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2008
• Last updated: March 10, 2010
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• inguinal hernia

• adult patient

Exclusion Criteria:

• patient not willing

• multiple recurrences

• inguinal pain without evidence of hernia

• femoral hernia

• large scrotal hernia

Study Design

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

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• cyanoacrylate glue
1 ml glue

Locations

Country	Name	City	State
Finland	Hannu Paajanen	Kuopio

Sponsors (3)

Lead Sponsor	Collaborator
Kuopio University Hospital	North Karelia Central Hospital, Paijat-Hame Hospital District

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Ong CC, Jacobsen AS, Joseph VT. Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial. Pediatr Surg Int. 2002 Sep;18(5-6):553-5. Epub 2002 Jun 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain		1 year	Yes
Secondary	hernia recurrence, quality of life		1 year	Yes