search
Back to results

Glubran Mesh Fixation in Lichtenstein Hernioplasty (Cyanoacr)

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
cyanoacrylate glue
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, inguinal hernioplasty, mesh fixation, Lichtenstein hernioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hannu Paajanen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

mesh fixation by absorbable sutures

mesh fixation by cyanoacrylate glue

Outcomes

Primary Outcome Measures

postoperative pain

Secondary Outcome Measures

hernia recurrence, quality of life

Full Information

First Posted
April 11, 2008
Last Updated
March 10, 2010
Sponsor
Kuopio University Hospital
Collaborators
North Karelia Central Hospital, Paijat-Hame Hospital District
search

1. Study Identification

Unique Protocol Identification Number
NCT00659542
Brief Title
Glubran Mesh Fixation in Lichtenstein Hernioplasty
Acronym
Cyanoacr
Official Title
Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kuopio University Hospital
Collaborators
North Karelia Central Hospital, Paijat-Hame Hospital District

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, inguinal hernioplasty, mesh fixation, Lichtenstein hernioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
mesh fixation by absorbable sutures
Arm Title
2
Arm Type
Experimental
Arm Description
mesh fixation by cyanoacrylate glue
Intervention Type
Procedure
Intervention Name(s)
cyanoacrylate glue
Other Intervention Name(s)
Glubran2 synthetic surgical glue
Intervention Description
1 ml glue
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
1 year
Secondary Outcome Measure Information:
Title
hernia recurrence, quality of life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: inguinal hernia adult patient Exclusion Criteria: patient not willing multiple recurrences inguinal pain without evidence of hernia femoral hernia large scrotal hernia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pekka Miettinen, MD, PhD
Organizational Affiliation
University hospital of Kuopio, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannu Paajanen
City
Kuopio
ZIP/Postal Code
1777
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
12415411
Citation
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.
Results Reference
background
PubMed Identifier
27864616
Citation
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.
Results Reference
derived
PubMed Identifier
21710480
Citation
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.
Results Reference
derived

Learn more about this trial

Glubran Mesh Fixation in Lichtenstein Hernioplasty

We'll reach out to this number within 24 hrs