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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000116
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : April 13, 2012
Information provided by (Responsible Party):
Mette Astrup Madsen, Zealand University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Inguinal Hernia Femoral Hernia Procedure: Fibrin glue Procedure: Tacks Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Fibrin glue Procedure: Tacks

Active Comparator: Tacks Procedure: Fibrin glue
Tissucol 2 ml

Primary Outcome Measures :
  1. Early pain after operation [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. haematoma in groin region [ Time Frame: day 10 ]
  2. seroma in groin region [ Time Frame: day 10 ]
  3. fatigue [ Time Frame: 10 days ]
  4. discomfort [ Time Frame: 6 month ]
  5. Postoperative nausea and vomiting (PONV) [ Time Frame: 10 days ]
  6. Use of Analgesics at PACU [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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

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 identifier (NCT number): NCT01000116

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Private Hospital Hamlet
Søborg, Denmark, 2160
Sponsors and Collaborators
Zealand University Hospital
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mette Astrup Madsen, M.D., Zealand University Hospital Identifier: NCT01000116    
Other Study ID Numbers: SJ-138
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012
Keywords provided by Mette Astrup Madsen, Zealand University Hospital:
Early pain
Fibrin glue
Additional relevant MeSH terms:
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Hernia, Inguinal
Hernia, Femoral
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive