Obstructive Sleep ApneaNCT03760341
Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients
A study testing adenoidectomy - cold method and adenoidectomy - hot method in people with Obstructive Sleep Apnea and Adenoid; Growth, run by Rambam Health Care Campus.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Obstructive Sleep Apnea, Adenoid; Growth
- What is being tested?
- adenoidectomy - cold method and adenoidectomy - hot method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 1 to 15
- Children with obstructive sleep apnea
- Children whose parents agreed to be enrolled in the research
Who cannot join
- Children who underwent adenoidectomy in the past
- Refusal for participation by the parent.
- a diagnosis of malignancy
- Unable to adhere follow up
About this study
Official title: Does the Technique of Adenoidectomy Influence the Results of the Surgery? A Prospective Randomized Single Blind Study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Adenoid; Growth
- Being tested
- adenoidectomy - cold method, adenoidectomy - hot method
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenoidectomy - cold methodProcedure or surgery
a surgery for adenoid removal or reduction under general anesthesia using surgical curretes
adenoidectomy - hot methodProcedure or surgery
a surgery for adenoid removal or reduction under general anesthesia using suction diathermy
| Study group | Role | What they receive |
|---|---|---|
| cold adenoidectomy group | Active comparator | this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - cold method Receives: Procedure: adenoidectomy - cold method |
| hot method adenoidectomy | Active comparator | this group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - hot method Receives: Procedure: adenoidectomy - hot method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Sleep Questionnaire scores
changes in the Pediatric Sleep Questionnaire scores compared to baseline (before the surgery)
Measured: a month and a year following the surgery
Secondary outcomes (2)
intra-operative complications
complications during the surgery (i.e. bleeding)
Measured: intraoperative
post-operative complications
complications following the surgery (i.e. fever, bleeding)
Measured: up till a month following the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Oct 2014
- Primary completion30 Aug 2018
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arie Gordin, MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760341
- Sponsor's protocol ID
- 0087-14-RMB
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Technique of Adenoidectomy Influence the Results of the Surgery? A Prospective Randomized Single Blind Study
- ClinicalTrials.gov ID
- NCT03760341
- Acronym / sponsor ID
- 0087-14-RMB
- Conditions
- Obstructive Sleep Apnea, Adenoid; Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold adenoidectomy group | Active comparator | Procedure: adenoidectomy - cold methodthis group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - cold method |
| hot method adenoidectomy | Active comparator | Procedure: adenoidectomy - hot methodthis group of patient will undergo adenoidectomy by the cold method intervention: adenoidectomy - hot method |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 1 to 15
- Children with obstructive sleep apnea
- Children whose parents agreed to be enrolled in the research
Key exclusion criteria (4 listed)
- Children who underwent adenoidectomy in the past
- Refusal for participation by the parent.
- a diagnosis of malignancy
- Unable to adhere follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adenoidectomy - cold methoda surgery for adenoid removal or reduction under general anesthesia using surgical curretes | Procedure or surgery | cold adenoidectomy group |
| adenoidectomy - hot methoda surgery for adenoid removal or reduction under general anesthesia using suction diathermy | Procedure or surgery | hot method adenoidectomy |
Primary outcome
Pediatric Sleep Questionnaire scores
Time frame: a month and a year following the surgery
changes in the Pediatric Sleep Questionnaire scores compared to baseline (before the surgery)
2 secondary outcomes
intra-operative complications
Time frame: intraoperative
post-operative complications
Time frame: up till a month following the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing adenoidectomy - cold method and adenoidectomy - hot method in people with Obstructive Sleep Apnea and Adenoid; Growth, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Sleep Questionnaire scores (time frame: a month and a year following the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.