HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
HemORL
Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
1 other identifier
interventional
74
1 country
1
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 and quicker re-feeding
- an easier haemostasis
- the simplification of the tonsillectomy surgical kit
- the decrease of dissection time
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 Oct 2014
Longer than P75 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
First Submitted
Initial submission to the registry
July 5, 2013
CompletedFirst Posted
Study publicly available on registry
July 22, 2013
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedApril 25, 2018
April 1, 2018
3.9 years
July 5, 2013
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostasis using bipolar forceps(electric power of 20W)
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Secondary Outcomes (10)
Assessment of the vacuum device hemostatic technique at his installation on the wound
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Assessment between two arm of the postoperative pain until 10 days after the surgery
10 days
Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group
Time between general anesthesia and discharge hospitalization: an average of one day
Comparison of surgery time between the 2 arm
An expected average of 2 hours
Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)
Until 11 days after surgery
- +5 more secondary outcomes
Study Arms (2)
Vacuum device surgery
EXPERIMENTALAt first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis
Conventional surgery
ACTIVE COMPARATORAt first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- HEMOSQUIDcollaborator
Study Sites (1)
University Hospital, Grenoble
Grenoble, Isère, 38043, France
Related Publications (3)
Guerrero K, Moreau-Gaudry A, Porcu P, Blin D. An innovative technique to control bleeding with vacuum device. Eur J Cardiothorac Surg. 2011 Jun;39(6):1070-2. doi: 10.1016/j.ejcts.2010.09.047. Epub 2010 Nov 12.
PMID: 21075003BACKGROUNDBrichon PY, Porcu P, Moreau-Gaudry A, Blin D. Extraction of substernal goitre using an innovative vacuum device. Eur J Cardiothorac Surg. 2012 Jul;42(1):178-9. doi: 10.1093/ejcts/ezs018. Epub 2012 Feb 13.
PMID: 22334630BACKGROUNDPorcu P, Moreau-Gaudry A, Chavanon O, Blin D. Haemostasis of a right ventricle-gunshot wound using a novel haemostatic vacuum device. Interact Cardiovasc Thorac Surg. 2012 Aug;15(2):294-6. doi: 10.1093/icvts/ivs103. Epub 2012 May 7.
PMID: 22566511BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien Schmerber, MD, PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2013
First Posted
July 22, 2013
Study Start
October 1, 2014
Primary Completion
September 1, 2018
Study Completion
February 1, 2019
Last Updated
April 25, 2018
Record last verified: 2018-04