- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659542
Glubran Mesh Fixation in Lichtenstein Hernioplasty (Cyanoacr)
March 10, 2010 updated by: Kuopio University Hospital
Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kuopio, Finland, 1777
- Hannu Paajanen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
mesh fixation by absorbable sutures
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|
Experimental: 2
mesh fixation by cyanoacrylate glue
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1 ml glue
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative pain
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hernia recurrence, quality of life
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pekka Miettinen, MD, PhD, University Hospital of Kuopio, Finland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Matikainen 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.
- Paajanen 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
April 11, 2008
First Submitted That Met QC Criteria
April 15, 2008
First Posted (Estimate)
April 16, 2008
Study Record Updates
Last Update Posted (Estimate)
March 11, 2010
Last Update Submitted That Met QC Criteria
March 10, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH5204518
- cyanoacrylate1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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