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Glubran Mesh Fixation in Lichtenstein Hernioplasty (Cyanoacr)

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ClinicalTrials.gov Identifier: NCT00659542
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : March 11, 2010
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: cyanoacrylate glue Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
Study Start Date : October 2007
Primary Completion Date : December 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
mesh fixation by absorbable sutures
Experimental: 2
mesh fixation by cyanoacrylate glue
Procedure: cyanoacrylate glue
1 ml glue
Other Name: Glubran2 synthetic surgical glue


Outcome Measures

Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. hernia recurrence, quality of life [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659542


Locations
Finland
Hannu Paajanen
Kuopio, Finland, 1777
Sponsors and Collaborators
Kuopio University Hospital
North Karelia Central Hospital
Paijat-Hame Hospital District
Investigators
Principal Investigator: Pekka Miettinen, MD, PhD University hospital of Kuopio, Finland
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hannu Paajanen/MD, PhD, Department of Surgery, Kuopio University Hospital, Finland
ClinicalTrials.gov Identifier: NCT00659542     History of Changes
Other Study ID Numbers: KUH5204518
cyanoacrylate1
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: March 11, 2010
Last Verified: March 2010

Keywords provided by Kuopio University Hospital:
inguinal hernia
inguinal hernioplasty
mesh fixation
Lichtenstein hernioplasty

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal