Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
Primary Purpose
Inguinal Hernia, Femoral Hernia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fibrin glue
Tacks
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Tapp, Early pain, well-being, Seroma, Haematoma, Fibrin glue, tacks
Eligibility 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
Sites / Locations
- Private Hospital Hamlet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fibrin glue
Tacks
Arm Description
Outcomes
Primary Outcome Measures
Early pain after operation
Secondary Outcome Measures
haematoma in groin region
seroma in groin region
fatigue
discomfort
Postoperative nausea and vomiting (PONV)
Use of Analgesics at PACU
Full Information
NCT ID
NCT01000116
First Posted
October 16, 2009
Last Updated
April 12, 2012
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01000116
Brief Title
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
Official Title
Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Femoral Hernia
Keywords
Tapp, Early pain, well-being, Seroma, Haematoma, Fibrin glue, tacks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibrin glue
Arm Type
Active Comparator
Arm Title
Tacks
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Fibrin glue
Intervention Description
Tissucol 2 ml
Intervention Type
Procedure
Intervention Name(s)
Tacks
Intervention Description
Protacks
Primary Outcome Measure Information:
Title
Early pain after operation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
haematoma in groin region
Time Frame
day 10
Title
seroma in groin region
Time Frame
day 10
Title
fatigue
Time Frame
10 days
Title
discomfort
Time Frame
6 month
Title
Postoperative nausea and vomiting (PONV)
Time Frame
10 days
Title
Use of Analgesics at PACU
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette A Tolver, M.D.
Organizational Affiliation
University Hospital Koege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thue Bisgaard, M.D. DMSc
Organizational Affiliation
University Hospital Koege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Poul Juul, M.D.
Organizational Affiliation
Private Hospital Hamlet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, M.D. DMSc
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Hospital Hamlet
City
Søborg
ZIP/Postal Code
2160
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23355162
Citation
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. Erratum In: Surg Endosc. 2013 Aug;27(8):2734.
Results Reference
derived
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Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
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