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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coblation | Active Comparator | coblation adenoidectomy |
|
| cold dissection | Active Comparator | cold dissection adenoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coblation (COBLATION II surgery system ,CE8001-01) | Device | comparison of two methods of operation : coblation and cold dissection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| cold dissection adenoidectomy | Device | comparison of two methods of operation : coblation and cold dissectionby currete |
|
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |