Back to resultsHemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children (HemORL)
Primary Purpose
Tonsillectomy, Hemorrhage, Postoperative Complications
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vacuum device
Conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Tonsillectomy focused on measuring tonsillectomy, children, vacuum, medical device, pain, hemorrhage, post-surgical complications
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University Hospital, GrenobleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vacuum device surgery
Conventional surgery
Arm Description
At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis
At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Assessment of the vacuum device hemostatic technique at his installation on the wound
Number of success or failure to install the device
Cases of no immediately hemostasis
Assessment between two arm of the postoperative pain until 10 days after the surgery
Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old)
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 first complaint of pain
Comparison of surgery time between the 2 arm
Time between the first incision and final wounds hemostasis verification
Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)
Time or/and day of the first meal without pain
Comparison between the 2 arms of the number of primary hemorrhages
Number of primary hemorrhages
Comparison between the 2 arms of the number of secondary hemorrhages
Number of secondary hemorrhages
Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
Number of rehospitalisation
Comparison between the 2 arms of the number of strong analgesics doses
Number of strong analgesics doses per day. Strong analgesics are used only if the child has a FLACC score higher than 3 (children from 3 to 7 years old) and a Faces Pain Scale score higher than 4 (children from 8 to 10 years old).
Clinician evaluation about the feasibility of the vacuum device installation
Score from a qualitative satisfaction scale
Full Information
NCT ID
NCT01904461
First Posted
July 5, 2013
Last Updated
April 23, 2018
Sponsor
University Hospital, Grenoble
Collaborators
HEMOSQUID
1. Study Identification
Unique Protocol Identification Number
NCT01904461
Brief Title
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Acronym
HemORL
Official Title
Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
HEMOSQUID
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillectomy, Hemorrhage, Postoperative Complications
Keywords
tonsillectomy, children, vacuum, medical device, pain, hemorrhage, post-surgical complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vacuum device surgery
Arm Type
Experimental
Arm Description
At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis
Arm Title
Conventional surgery
Arm Type
Active Comparator
Arm Description
At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis
Intervention Type
Device
Intervention Name(s)
Vacuum device
Other Intervention Name(s)
-Suction cup, -Redon 600ml
Intervention Type
Procedure
Intervention Name(s)
Conventional surgery
Primary Outcome Measure Information:
Title
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
Description
Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostasis using bipolar forceps(electric power of 20W)
Time Frame
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Secondary Outcome Measure Information:
Title
Assessment of the vacuum device hemostatic technique at his installation on the wound
Description
Number of success or failure to install the device
Cases of no immediately hemostasis
Time Frame
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Title
Assessment between two arm of the postoperative pain until 10 days after the surgery
Description
Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old)
Time Frame
10 days
Title
Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group
Description
Time between general anesthesia and first complaint of pain
Time Frame
Time between general anesthesia and discharge hospitalization: an average of one day
Title
Comparison of surgery time between the 2 arm
Description
Time between the first incision and final wounds hemostasis verification
Time Frame
An expected average of 2 hours
Title
Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)
Description
Time or/and day of the first meal without pain
Time Frame
Until 11 days after surgery
Title
Comparison between the 2 arms of the number of primary hemorrhages
Description
Number of primary hemorrhages
Time Frame
Until 24 hours after surgery
Title
Comparison between the 2 arms of the number of secondary hemorrhages
Description
Number of secondary hemorrhages
Time Frame
From 24 hours after surgery until 11 days after surgery
Title
Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
Description
Number of rehospitalisation
Time Frame
From 24 hours after surgery until 11 days after surgery
Title
Comparison between the 2 arms of the number of strong analgesics doses
Description
Number of strong analgesics doses per day. Strong analgesics are used only if the child has a FLACC score higher than 3 (children from 3 to 7 years old) and a Faces Pain Scale score higher than 4 (children from 8 to 10 years old).
Time Frame
Until 11 days after surgery
Title
Clinician evaluation about the feasibility of the vacuum device installation
Description
Score from a qualitative satisfaction scale
Time Frame
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Schmerber, MD,PhD
Email
Echipon@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Moreau-Gaudry, MD, PhD
Email
Echipon@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Schmerber, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Grenoble
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Chipon
First Name & Middle Initial & Last Name & Degree
Alice Hitter, MD
First Name & Middle Initial & Last Name & Degree
Anne Rivron, MD
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Alibeu, MD
First Name & Middle Initial & Last Name & Degree
Elea Lamblin, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21075003
Citation
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.
Results Reference
background
PubMed Identifier
22334630
Citation
Brichon 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.
Results Reference
background
PubMed Identifier
22566511
Citation
Porcu 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.
Results Reference
background
Links:
URL
http://www.cic-it-grenoble.fr/
Description
Website of the Grenoble clinical investigation center - Technological Innovation
Learn more about this trial
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
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