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

Not Applicable

• Conditions: Tonsillectomy; Hemorrhage; Postoperative Complications
• Interventions: Procedure: Conventional surgery; Device: Vacuum device

• Registration Number: NCT01904461
• Lead Sponsor: University Hospital, Grenoble

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Study Start: 2014-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25
• Primary Completion: 2018-09
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional surgery	Conventional surgery	At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis
Vacuum device surgery	Vacuum device	At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Comparison between the 2 arms of the number of primary hemorrhages	Until 24 hours after surgery	Number of primary hemorrhages
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).
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
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 surgery time between the 2 arm	An expected average of 2 hours	Time between the first incision and final wounds hemostasis verification
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 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 between the 2 arms of the number of secondary hemorrhages	From 24 hours after surgery until 11 days after surgery	Number of secondary hemorrhages
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

Trial Locations

Locations (1)

University Hospital, Grenoble; 🇫🇷 Grenoble, Isère, France