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Glubran Mesh Fixation in Lichtenstein Hernioplasty (Cyanoacr)

This study has been completed.
Sponsor:
Collaborators:
North Karelia Central Hospital
Paijat-Hame Hospital District
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00659542
First received: April 11, 2008
Last updated: March 10, 2010
Last verified: March 2010

April 11, 2008
March 10, 2010
October 2007
December 2008   (final data collection date for primary outcome measure)
postoperative pain [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00659542 on ClinicalTrials.gov Archive Site
hernia recurrence, quality of life [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Glubran Mesh Fixation in Lichtenstein Hernioplasty
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Inguinal Hernia
Procedure: cyanoacrylate glue
1 ml glue
Other Name: Glubran2 synthetic surgical glue
  • No Intervention: 1
    mesh fixation by absorbable sutures
  • Experimental: 2
    mesh fixation by cyanoacrylate glue
    Intervention: Procedure: cyanoacrylate glue

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • inguinal hernia
  • adult patient

Exclusion Criteria:

  • patient not willing
  • multiple recurrences
  • inguinal pain without evidence of hernia
  • femoral hernia
  • large scrotal hernia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00659542
KUH5204518, cyanoacrylate1
No
Dr. Hannu Paajanen/MD, PhD, Department of Surgery, Kuopio University Hospital, Finland
Kuopio University Hospital
  • North Karelia Central Hospital
  • Paijat-Hame Hospital District
Principal Investigator: Pekka Miettinen, MD, PhD University hospital of Kuopio, Finland
Kuopio University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP