Coblation Versus Cold Adenoidectomy -Safety and Efficiency
Overview
- Phase
- Not Applicable
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 60
- Primary Endpoint
- safety (bleeding , dehydration or any other complications)
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 12 Months to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
safety (bleeding , dehydration or any other complications)
Time Frame: percent of bleeding and dehydration
measure the event of bleeding , dehydration or any other complications
Secondary Outcomes
- efficacy (pain post operation by scales evaluation)(pain and examination for residual adenoid tissue)