Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
1 other identifier
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedAugust 26, 2024
August 1, 2024
1.9 years
October 16, 2009
August 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early pain after operation
1 month
Secondary Outcomes (6)
haematoma in groin region
day 10
seroma in groin region
day 10
fatigue
10 days
discomfort
6 month
Postoperative nausea and vomiting (PONV)
10 days
- +1 more secondary outcomes
Study Arms (2)
Fibrin glue
ACTIVE COMPARATORTacks
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- unilateral groin hernia
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA I-III
- fluent Danish
You may not qualify if:
- converting to open operation
- low compliance
- daily use of morphine or similar drugs daily in the last month
- complications to the operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Private Hospital Hamlet
Søborg, 2160, Denmark
Related Publications (1)
Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26.
PMID: 23355162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 22, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2011
Study Completion
February 1, 2012
Last Updated
August 26, 2024
Record last verified: 2024-08