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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Postoperative Complications; Hemorrhage; Tonsillectomy

Treatments: Procedure: Conventional surgery; Device: Vacuum device

Study type: Interventional

Funder types: Other

Identifiers

NCT01904461

HemORL-DCIC-1211

Details and patient eligibility

About

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

Enrollment: 74 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Vacuum device surgery

Experimental group

Description:

At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis

Treatment:

Device: Vacuum device

Conventional surgery

Active Comparator group

Description:

At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis

Treatment:

Procedure: Conventional surgery