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

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

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
Active Comparator: Tacks Procedure: Fibrin glue
Tissucol 2 ml


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

Inclusion Criteria:

  • unilateral groin hernia
  • planned laparoscopic inguinal or femoral herniorrhaphy
  • 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
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Please refer to this study by its identifier: NCT01000116

Private Hospital Hamlet
Søborg, Denmark, 2160
Sponsors and Collaborators
University Hospital Koge
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 Herlev Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mette Astrup Madsen, M.D., University Hospital Koge 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:
Early pain
Fibrin glue

Additional relevant MeSH terms:
Hernia, Femoral
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical
Fibrin Tissue Adhesive
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016