Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Not Applicable

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: coblation (COBLATION II surgery system ,CE8001-01); Device: cold dissection adenoidectomy

• Registration Number: NCT02312947
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Primary Completion: 2014-12
• Study First Submitted: 2014-12-06
• Study First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Study First Posted: 2014-12-09
• Last Update Posted: 2014-12-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
coblation	coblation (COBLATION II surgery system ,CE8001-01)	coblation adenoidectomy
cold dissection	cold dissection adenoidectomy	cold dissection adenoidectomy

Primary Outcome Measures

Name	Time	Method
safety (bleeding , dehydration or any other complications)	percent of bleeding and dehydration	measure the event of bleeding , dehydration or any other complications

Secondary Outcome Measures

Name	Time	Method
efficacy (pain post operation by scales evaluation)	pain and examination for residual adenoid tissue	pain post operation by scales evaluation and determination whether adenoid tissue left behind after each methods of operation