TonsillectomyHemORLNCT01904461
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
A study testing Vacuum device and Conventional surgery in people with Tonsillectomy and Hemorrhage, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Tonsillectomy, Hemorrhage, Postoperative Complications
- What is being tested?
- Vacuum device and Conventional surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sébastien Schmerber, MD,PhD contact
Alexandre Moreau-Gaudry, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital, Grenoble
Grenoble, Isère, 38043
Emilie Chipon
Alice Hitter, MD
About this study
Official title: Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
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
- Being tested
- Vacuum device, Conventional surgery
- Keywords
- tonsillectomy, children, vacuum, medical device, pain, hemorrhage, post-surgical complications
- Medical subject headings
- Hemorrhage, Postoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum deviceDevice
Also called -Suction cup, -Redon 600ml
Conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Vacuum device surgery | Experimental | At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis Receives: Device: Vacuum device |
| Conventional surgery | Active comparator | At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis Receives: Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- Number of success or failure to install the device
- Cases of no immediately hemostasis
Measured: 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
Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old)
Measured: 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 first complaint of pain
Measured: Time between general anesthesia and discharge hospitalization: an average of one day
Comparison of surgery time between the 2 arm
Time between the first incision and final wounds hemostasis verification
Measured: An expected average of 2 hours
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
Measured: Until 11 days after surgery
Comparison between the 2 arms of the number of primary hemorrhages
Number of primary hemorrhages
Measured: Until 24 hours after surgery
Comparison between the 2 arms of the number of secondary hemorrhages
Number of secondary hemorrhages
Measured: From 24 hours after surgery until 11 days after surgery
Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
Number of rehospitalisation
Measured: From 24 hours after surgery until 11 days after surgery
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).
Measured: Until 11 days after surgery
Clinician evaluation about the feasibility of the vacuum device installation
Score from a qualitative satisfaction scale
Measured: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startOct 2014
- Primary completionSep 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- HEMOSQUID
- Responsible party
- Sponsor
- Investigators
- Sébastien Schmerber, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904461
- Sponsor's protocol ID
- HemORL-DCIC-1211
- Acronym
- HemORL
- Status last verified
- Apr 2018
- First submitted
- 5 Jul 2013
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21075003Brichon 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.
PubMed 22334630Porcu 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.
PubMed 22566511
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
- ClinicalTrials.gov ID
- NCT01904461
- Acronym / sponsor ID
- HemORL / HemORL-DCIC-1211
- Conditions
- Tonsillectomy, Hemorrhage, Postoperative Complications
- Keywords
- tonsillectomy, children, vacuum, medical device, pain, hemorrhage, post-surgical complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- HEMOSQUID
- Study start
- Oct 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum device surgery | Experimental | Device: Vacuum deviceAt 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 comparator | Procedure: Conventional surgeryAt first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum deviceAlso: -Suction cup, -Redon 600ml | Device | Vacuum device surgery |
| Conventional surgery | Procedure or surgery | Conventional surgery |
Primary outcome
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
Time frame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostasis using bipolar forceps(electric power of 20W)
10 secondary outcomes
Assessment of the vacuum device hemostatic technique at his installation on the wound
Time frame: 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
Time frame: 10 days
Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group
Time frame: Time between general anesthesia and discharge hospitalization: an average of one day
Comparison of surgery time between the 2 arm
Time frame: An expected average of 2 hours
Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)
Time frame: Until 11 days after surgery
Comparison between the 2 arms of the number of primary hemorrhages
Time frame: Until 24 hours after surgery
Comparison between the 2 arms of the number of secondary hemorrhages
Time frame: From 24 hours after surgery until 11 days after surgery
Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
Time frame: From 24 hours after surgery until 11 days after surgery
Comparison between the 2 arms of the number of strong analgesics doses
Time frame: Until 11 days after surgery
Clinician evaluation about the feasibility of the vacuum device installation
Time frame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Background: PubMed 21075003Guerrero 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.
- Background: PubMed 22334630Brichon 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.
- Background: PubMed 22566511Porcu 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.
- Website of the Grenoble clinical investigation center - Technological InnovationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Schmerber, MD,PhD contact
Alexandre Moreau-Gaudry, MD, PhD contact
Sébastien Schmerber, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum device and Conventional surgery in people with Tonsillectomy and Hemorrhage, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Schmerber, MD,PhD (Echipon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group (time frame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904461, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.