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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000116
First Posted: October 22, 2009
Last Update Posted: April 13, 2012
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.
Information provided by (Responsible Party):
Mette Astrup Madsen, University Hospital Koge
  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
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.

Resource links provided by NLM:


Further study details as provided by Mette Astrup Madsen, University Hospital Koge:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
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): 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 Herlev Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Astrup Madsen, M.D., University Hospital Koge
ClinicalTrials.gov Identifier: NCT01000116     History of Changes
Other Study ID Numbers: SJ-138
First Submitted: October 16, 2009
First Posted: October 22, 2009
Last Update Posted: April 13, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Femoral
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive
Hemostatics
Coagulants