Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Sleep Apnea, Obstructive

Treatments: Device: coblation (COBLATION II surgery system ,CE8001-01); Device: cold dissection adenoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02312947

0047-14-HYMC

Details and patient eligibility

About

Comparative two methods of adenoidectomy means the coblation adenoidectomy with the cold dissection adenoidectomy specifically inquire which method is safer and more efficient.

Full description

Obstructive sleep apnea(osa) in children is a very bother and frequent problem with clinical and behavioral impacts. The hypertrophied adenoid tissue obstructs the air way in the nasopharynx that initiates the common symptoms. The treatment from that concerning problems is in the operation rooms by diversity surgical methods, the very older one is the cold dissection adenoidectomy.

Recently many surgeons use the coblation system as a preferred method for adenoidectomy. This method was proof as a safe and efficient especially referring to the bleeding and the dehydration risk .

Many children that operated by the cold dissection forced to perform another one or two operations presumably due to the adenoid tissue that did not removed completely from the first operation .

our hypothesis is that the coblation systemis a safe and eficient method for adenoidectomy.

The aims of this project is to verify if our theory is corect by blinded comparision between two methods.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 months to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children with obstructive symptoms
• the children must perform nasopharyngoscopy with clear evidence of obstructive symptoms ( video or polysomnography more than 5 RDI)

Exclusion criteria

• without any recent upper respiratory tract infection or clinical suspicious of adenoiditis.
• tonsillectomy
• Non randomalization, not blinded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

coblation

Active Comparator group

Description:

coblation adenoidectomy

Treatment:

Device: coblation (COBLATION II surgery system ,CE8001-01)

cold dissection

Active Comparator group

Description:

cold dissection adenoidectomy

Treatment:

Device: cold dissection adenoidectomy