Glubran Mesh Fixation in Lichtenstein Hernioplasty
Cyanoacr
Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 11, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMarch 11, 2010
March 1, 2010
1.2 years
April 11, 2008
March 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
1 year
Secondary Outcomes (1)
hernia recurrence, quality of life
1 year
Study Arms (2)
1
NO INTERVENTIONmesh fixation by absorbable sutures
2
EXPERIMENTALmesh fixation by cyanoacrylate glue
Interventions
Eligibility Criteria
You may qualify if:
- inguinal hernia
- adult patient
You may not qualify if:
- patient not willing
- multiple recurrences
- inguinal pain without evidence of hernia
- femoral hernia
- large scrotal hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- North Karelia Central Hospitalcollaborator
- Paijat-Hame Hospital Districtcollaborator
Study Sites (1)
Hannu Paajanen
Kuopio, Kuopio, 1777, Finland
Related Publications (3)
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. doi: 10.1007/s00383-002-0728-0. Epub 2002 Jun 14.
PMID: 12415411BACKGROUNDMatikainen M, Kossi J, Silvasti S, Hulmi T, Paajanen H. Randomized Clinical Trial Comparing Cyanoacrylate Glue Versus Suture Fixation in Lichtenstein Hernia Repair: 7-Year Outcome Analysis. World J Surg. 2017 Jan;41(1):108-113. doi: 10.1007/s00268-016-3801-x.
PMID: 27864616DERIVEDPaajanen H, Kossi J, Silvasti S, Hulmi T, Hakala T. Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28.
PMID: 21710480DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pekka Miettinen, MD, PhD
University hospital of Kuopio, Finland
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2008
First Posted
April 16, 2008
Study Start
October 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
March 11, 2010
Record last verified: 2010-03