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Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Astrup Madsen, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01000116
First received: October 16, 2009
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.


Condition Intervention
Inguinal Hernia
Femoral Hernia
 Procedure: Fibrin glue
Procedure: Tacks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • Early pain after operation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • haematoma in groin region [ Time Frame: day 10 ] [ Designated as safety issue: No ]
  • seroma in groin region [ Time Frame: day 10 ] [ Designated as safety issue: No ]
  • fatigue [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • discomfort [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Postoperative nausea and vomiting (PONV) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Use of Analgesics at PACU [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fibrin glue Procedure: Tacks
Protacks
Active Comparator: Tacks Procedure: Fibrin glue
Tissucol 2 ml

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral groin hernia
  • planned laparoscopic inguinal or femoral herniorrhaphy
  • ASA I-III
  • fluent Danish

Exclusion Criteria:

  • converting to open operation
  • low compliance
  • daily use of morphine or similar drugs daily in the last month
  • complications to the operation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000116

Locations
Denmark
Private Hospital Hamlet
Søborg, Denmark, 2160
Sponsors and Collaborators
University Hospital Koge
Investigators
Principal Investigator: Mette A Tolver, M.D. University Hospital Koege
Principal Investigator: Thue Bisgaard, M.D. DMSc University Hospital Koege
Principal Investigator: Poul Juul, M.D. Private Hospital Hamlet
Principal Investigator: Jacob Rosenberg, M.D. DMSc University Hospital Herlev
  More Information

No publications provided

Responsible Party: Mette Astrup Madsen, M.D., University Hospital Koge
ClinicalTrials.gov Identifier: NCT01000116     History of Changes
Other Study ID Numbers: SJ-138
Study First Received: October 16, 2009
Last Updated: April 12, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital Koge:
Tapp
Early pain
well-being
Seroma
 Haematoma
Fibrin glue
tacks

Additional relevant MeSH terms:
Hernia
Hernia, Femoral
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013