Status:
COMPLETED
Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial
Lead Sponsor:
Medical University of Vienna
Conditions:
Tonsillitis Chronic
Tonsillectomy
Eligibility:
All Genders
14-85 years
Phase:
NA
Brief Summary
Tonsillectomies are frequently followed by severe postoperative pain, hence high analgetics consumption and prolonged hospitalization. Also, postoperative hemorrhages can be hazardous. Constant evalua...
Detailed Description
Although stricter indication criteria have been implanted (especially in Austria since 2008), tonsillectomies are still performed very frequently. Post-surgical bleeding can potentially be life-threat...
Eligibility Criteria
Inclusion
- Age 14 and older
- Written informed consent (in case of underage participant also parental informed consent)
- Assigned for Tonsillectomy on both sides due to chronic tonsillitis
Exclusion
- History of abscesses in tonsillar region
- Coagulation disorder (as assessed by a coagulation questionnaire and blood results)
- Suspicion of untreated malignancy of any kind
- Planned removal of only one tonsil
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03793816
Start Date
September 1 2019
End Date
December 21 2020
Last Update
January 5 2021
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090