Clinical trial NCT01904461: HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Official title: Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tonsillectomy
Hemorrhage
Postoperative Complications
Keywords: tonsillectomy
children
vacuum
medical device
pain
hemorrhage
post-surgical complications
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: HEMOSQUID
First posted: 2013-07-22
Enrollment: 74
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
timeFrame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Secondary outcomes:
measure: Assessment of the vacuum device hemostatic technique at his installation on the wound
timeFrame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
measure: Assessment between two arm of the postoperative pain until 10 days after the surgery
timeFrame: 10 days
measure: Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group
timeFrame: Time between general anesthesia and discharge hospitalization: an average of one day
measure: Comparison of surgery time between the 2 arm
timeFrame: An expected average of 2 hours
measure: Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)
timeFrame: Until 11 days after surgery
measure: Comparison between the 2 arms of the number of primary hemorrhages
timeFrame: Until 24 hours after surgery
measure: Comparison between the 2 arms of the number of secondary hemorrhages
timeFrame: From 24 hours after surgery until 11 days after surgery
measure: Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
timeFrame: From 24 hours after surgery until 11 days after surgery
measure: Comparison between the 2 arms of the number of strong analgesics doses
timeFrame: Until 11 days after surgery
measure: Clinician evaluation about the feasibility of the vacuum device installation
timeFrame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Sébastien Schmerber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.