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
  Purpose

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 Intervention Phase
Inguinal Hernia
Procedure: cyanoacrylate glue
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hernia recurrence, quality of life [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: April 11, 2008
Last Updated: March 10, 2010
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on August 25, 2014