HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
NCT01904461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2018-04-25
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 and quicker re-feeding
* an easier haemostasis
* the simplification of the tonsillectomy surgical kit
* the decrease of dissection time
Conditions
- Tonsillectomy
- Hemorrhage
- Postoperative Complications
Interventions
- DEVICE
-
Vacuum device
- PROCEDURE
-
Conventional surgery
Sponsors & Collaborators
-
HEMOSQUID
collaborator UNKNOWN -
University Hospital, Grenoble
lead OTHER
Principal Investigators
-
Sébastien Schmerber, MD, PhD · University Hospital, Grenoble
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2018-09-30
- Completion
- 2019-02-28
Countries
- France
Study Locations
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