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

Postoperative Complications Clinical Trial

— HemORL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01904461
• Other study ID #: HemORL-DCIC-1211
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2013
• Last updated: April 23, 2018
• Start date: October 2014
• Est. completion date: February 2019

Study information

• Verified date: April 2018
• Source: University Hospital, Grenoble
• Contact: Sébastien Schmerber, MD,PhD
• Email: Echipon[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 time

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: February 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Complications
• Tonsillectomy

Intervention

Device:
• Vacuum device

Procedure:
• Conventional surgery

Locations

Country	Name	City	State
France	University Hospital, Grenoble	Grenoble	Isère

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	HEMOSQUID

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Comparison of surgery time between the 2 arm	Time between the first incision and final wounds hemostasis verification	An expected average of 2 hours
Secondary	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
Secondary	Comparison between the 2 arms of the number of primary hemorrhages	Number of primary hemorrhages	Until 24 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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