search
Back to results

Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients

Primary Purpose

Obstructive Sleep Apnea, Adenoid; Growth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
adenoidectomy - cold method
adenoidectomy - hot method
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 1 to 15
  2. Children with obstructive sleep apnea
  3. Children whose parents agreed to be enrolled in the research

Exclusion Criteria:

  1. Children who underwent adenoidectomy in the past
  2. Refusal for participation by the parent.
  3. a diagnosis of malignancy
  4. Unable to adhere follow up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    cold adenoidectomy group

    hot method adenoidectomy

    Arm Description

    this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - cold method

    this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - hot method

    Outcomes

    Primary Outcome Measures

    Pediatric Sleep Questionnaire scores
    changes in the Pediatric Sleep Questionnaire scores compared to baseline (before the surgery)

    Secondary Outcome Measures

    intra-operative complications
    complications during the surgery (i.e. bleeding)
    post-operative complications
    complications following the surgery (i.e. fever, bleeding)

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    September 16, 2019
    Sponsor
    Rambam Health Care Campus
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03760341
    Brief Title
    Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients
    Official Title
    Does the Technique of Adenoidectomy Influence the Results of the Surgery? A Prospective Randomized Single Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2014 (Actual)
    Primary Completion Date
    August 30, 2018 (Actual)
    Study Completion Date
    March 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Adenoidectomy is one of the most common procedures done by the otolaryngologist. The procedure can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and post-operative outcomes. However, the long term clinical outcome in improving the sleep disorder symptoms was never compared between the two methods. Objective: To compare the advantages using the hot method compared to the cold method adenoidectomy in the long term follow up. Methods: A prospective, randomized, single blinded study of children undergoing adenoidectomy between the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques. The primary outcome was change of the Pediatric Sleep Questionnaire Score (PSQ) scores one month and one year after surgery.
    Detailed Description
    The most common cause of sleep disordered breathing in children is enlargement of the adenoids and tonsils relative to the upper airway space. Obstructive sleep apnea could cause pulmonary and cardiovascular complications, and could influence negatively the l quality of life of the child. Adenoidectomy with or without tonsillectomy is one of the most common procedures done by the otolaryngologist. Adenoidectomy is performed under general anesthesia .The main indications for the procedure include adenoid hypertrophy, obstructive sleep apnea, chronic adenoiditis, and chronic otitis media (ref 1). Historically recommended instrumentation for performing adenoidectomy has varied from a steel nail, cutting or biting forceps, adenotomes and adenoid curettes. In 2009 the National institute for health and clinical excellence has published guidelines on the use of suction diathermia adenoidectomy which showed that the method is as effective as or even more than cold method, the method is considered more secure with some advantage in terms of complications of adenoidectomy2, Several studies compared different surgical methods for adenoidectomy. Usually the parameters for comparison were : surgery time, amount of bleeding, complications and regrowth rate (ref 2). None of them examined long term clinical outcome. The GOLD STANDARD in terms of evaluation of sleep apnea in children is PSG (Polysomnography). However, due to the availability and cost of this test, new methods for assessing these children are studied. Alternatively, some questionnaires were prepared in order to evaluate obstructive sleep apnea in children. One of these questionnaires is the PEDIATRIC SLEEP QUESTIONNARE that contains 22 easy to understand questions which should be answered by YES/NO/IDONT KNOW (ref 3). A result of >0.33 (more than 7 questions answered by yes) should be taken to PSG . In the year 2000 the same group that created the questionnaire published an article in the Sleep Medicine Journal that showed high sensitivity and high validity for sleep apnea diagnosis. The conclusion was that this questionnaire can replace the PSG in clinical trials (ref 3). In 2007 the same group released another study which demonstrates the advantage of the questionnaire compared to PSG evaluation in terms of cognitive and behavioral morbidity of in OSA (Obstructive Sleep Apnea) (ref 4). In this study the investigators aim to investigate whether there any advantages using SUCTION DIATHERMY in adenoidectomy versus Cold method adenoidectomy in terms of sleep questionnaire score.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Adenoid; Growth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cold adenoidectomy group
    Arm Type
    Active Comparator
    Arm Description
    this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - cold method
    Arm Title
    hot method adenoidectomy
    Arm Type
    Active Comparator
    Arm Description
    this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - hot method
    Intervention Type
    Procedure
    Intervention Name(s)
    adenoidectomy - cold method
    Intervention Description
    a surgery for adenoid removal or reduction under general anesthesia using surgical curretes
    Intervention Type
    Procedure
    Intervention Name(s)
    adenoidectomy - hot method
    Intervention Description
    a surgery for adenoid removal or reduction under general anesthesia using suction diathermy
    Primary Outcome Measure Information:
    Title
    Pediatric Sleep Questionnaire scores
    Description
    changes in the Pediatric Sleep Questionnaire scores compared to baseline (before the surgery)
    Time Frame
    a month and a year following the surgery
    Secondary Outcome Measure Information:
    Title
    intra-operative complications
    Description
    complications during the surgery (i.e. bleeding)
    Time Frame
    intraoperative
    Title
    post-operative complications
    Description
    complications following the surgery (i.e. fever, bleeding)
    Time Frame
    up till a month following the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 1 to 15 Children with obstructive sleep apnea Children whose parents agreed to be enrolled in the research Exclusion Criteria: Children who underwent adenoidectomy in the past Refusal for participation by the parent. a diagnosis of malignancy Unable to adhere follow up

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients

    We'll reach out to this number within 24 hrs