Hemorrhage, Postoperative Complications, Tonsillectomy
Conditions
Keywords
tonsillectomy, children, vacuum, medical device, pain, hemorrhage, post-surgical complications
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
Interventions
DEVICEVacuum device
PROCEDUREConventional surgery
Sponsors
University Hospital, Grenoble
HEMOSQUID
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment between two arm of the postoperative pain until 10 days after the surgery | 10 days | 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 discharge hospitalization: an average of one day | Time between general anesthesia and first complaint of pain |
| Comparison of surgery time between the 2 arm | An expected average of 2 hours | 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) | Until 11 days after surgery | Time or/and day of the first meal without pain |
| 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 | * Number of success or failure to install the device * Cases of no immediately hemostasis |
| Comparison between the 2 arms of the number of secondary hemorrhages | From 24 hours after surgery until 11 days after surgery | Number of secondary hemorrhages |
| Comparison between the 2 arms of the number of rehospitalisation (all circumstances) | From 24 hours after surgery until 11 days after surgery | Number of rehospitalisation |
| Comparison between the 2 arms of the number of strong analgesics doses | Until 11 days after surgery | 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 | From the beginning to the end of a tonsillectomy: an expected average of 2 hours | Score from a qualitative satisfaction scale |
| Comparison between the 2 arms of the number of primary hemorrhages | Until 24 hours after surgery | Number of primary hemorrhages |
Countries
France
Contacts
Primary ContactSébastien Schmerber, MD,PhD
Backup ContactAlexandre Moreau-Gaudry, MD, PhD
Outcome results
None listed