Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Coblation Versus Cold Adenoidectomy -Safety and Efficiency

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: coblation (COBLATION II surgery system ,CE8001-01)
* Device: cold dissection adenoidectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: coblation<br>coblation adenoidectomy | Device: coblation (COBLATION II surgery system ,CE8001-01)<br>* comparison of two methods of operation : coblation and cold dissection<br>* Other names: COBLATION II surgery system ,CE8001-01;|
| Active Comparator: cold dissection<br>cold dissection adenoidectomy | Device: cold dissection adenoidectomy<br>* comparison of two methods of operation : coblation and cold dissectionby currete<br>* Other names: currete adenoidectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety (bleeding , dehydration or any other complications) | measure the event of bleeding , dehydration or any other complications | percent of bleeding and dehydration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy (pain post operation by scales evaluation) | pain post operation by scales evaluation and determination whether adenoid tissue left behind after each methods of operation | pain and examination for residual adenoid tissue |