HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children

Study Overview
=================
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

Official Title
-----------------
Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children

Conditions
-----------------
Tonsillectomy, Hemorrhage, Postoperative Complications

Intervention / Treatment
-----------------
* Device: Vacuum device
* Procedure: Conventional surgery


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum device surgery<br>At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis | Device: Vacuum device<br> <br> * Other names: -Redon 600ml;|
| Active Comparator: Conventional surgery<br>At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis | Procedure: Conventional surgery<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | 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 | Until 11 days after surgery | 
| Comparison between the 2 arms of the number of primary hemorrhages | Number of primary hemorrhages | Until 24 hours after surgery | 
| Comparison between the 2 arms of the number of secondary hemorrhages | Number of secondary hemorrhages | 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 | 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). | Until 11 days after surgery | 
| Clinician evaluation about the feasibility of the vacuum device installation | Score from a qualitative satisfaction scale | From the beginning to the end of a tonsillectomy: an expected average of 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tonsillectomy, children, vacuum, medical device, pain, hemorrhage, post-surgical complications