Status:
UNKNOWN
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
HEMOSQUID
Conditions:
Tonsillectomy
Hemorrhage
Eligibility:
All Genders
3-10 years
Phase:
NA
Brief Summary
The long-term objective of this study is to prove: * the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the number of secondary hemorrhages * the decrease of pain an...
Eligibility Criteria
Inclusion
- children from 3 to 10 years old undergoing tonsillectomy (with or without adenoidectomy)
- children without known hemophilia or any coagulation trouble
- children speaking and understanding French
- children's both parents must speak and understand French
- children's both parents must be affiliate to social security or similarly regime
Exclusion
- children with known allergy to silicone
- refusal to consent: from child's age to consent or from both parents
- telephone monitoring refusal
- protected person referred to in Articles L1121-6 of the Code of Public Health
- children's both parents are protected persons referred to in Articles L1121-8 of the Code of Public Health
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01904461
Start Date
October 1 2014
End Date
February 1 2019
Last Update
April 25 2018
Active Locations (1)
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1
University Hospital, Grenoble
Grenoble, Isère, France, 38043