Coblation Versus Cold Adenoidectomy -Safety and Efficiency
Primary Purpose
Sleep Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coblation (COBLATION II surgery system ,CE8001-01)
cold dissection adenoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
coblation
cold dissection
Arm Description
coblation adenoidectomy
cold dissection adenoidectomy
Outcomes
Primary Outcome Measures
safety (bleeding , dehydration or any other complications)
measure the event of bleeding , dehydration or any other complications
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02312947
First Posted
December 6, 2014
Last Updated
December 8, 2014
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02312947
Brief Title
Coblation Versus Cold Adenoidectomy -Safety and Efficiency
Official Title
Coblation Versus Cold Adenoidectomy -Safety and Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
coblation
Arm Type
Active Comparator
Arm Description
coblation adenoidectomy
Arm Title
cold dissection
Arm Type
Active Comparator
Arm Description
cold dissection adenoidectomy
Intervention Type
Device
Intervention Name(s)
coblation (COBLATION II surgery system ,CE8001-01)
Other Intervention Name(s)
COBLATION II surgery system ,CE8001-01
Intervention Description
comparison of two methods of operation : coblation and cold dissection
Intervention Type
Device
Intervention Name(s)
cold dissection adenoidectomy
Other Intervention Name(s)
currete adenoidectomy
Intervention Description
comparison of two methods of operation : coblation and cold dissectionby currete
Primary Outcome Measure Information:
Title
safety (bleeding , dehydration or any other complications)
Description
measure the event of bleeding , dehydration or any other complications
Time Frame
percent of bleeding and dehydration
Secondary Outcome Measure Information:
Title
efficacy (pain post operation by scales evaluation)
Description
pain post operation by scales evaluation and determination whether adenoid tissue left behind after each methods of operation
Time Frame
pain and examination for residual adenoid tissue
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
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Coblation Versus Cold Adenoidectomy -Safety and Efficiency
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