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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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

12 Months - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 6, 2014
    Last Updated
    December 8, 2014
    Sponsor
    Hillel Yaffe Medical Center
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    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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