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
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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
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
NCT ID
NCT03760341
First Posted
November 29, 2018
Last Updated
September 16, 2019
Sponsor
Rambam Health Care Campus
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