Coblation Versus Cold Adenoidectomy -Safety and Efficiency
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: coblation
coblation adenoidectomy
|
comparison of two methods of operation : coblation and cold dissection
Other Names:
|
|
Active Comparator: cold dissection
cold dissection adenoidectomy
|
comparison of two methods of operation : coblation and cold dissectionby currete
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
safety (bleeding , dehydration or any other complications)
Time Frame: percent of bleeding and dehydration
|
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)
Time Frame: 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
|
pain and examination for residual adenoid tissue
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0047-14-HYMC
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