Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients

NCT ID: NCT03760341

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2019-03-20

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.

Conditions

Obstructive Sleep Apnea; Adenoid; Growth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cold adenoidectomy group

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

Group Type: ACTIVE_COMPARATOR

adenoidectomy - cold method

Intervention Type: PROCEDURE

a surgery for adenoid removal or reduction under general anesthesia using surgical curretes

hot method adenoidectomy

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

Group Type: ACTIVE_COMPARATOR

adenoidectomy - hot method

Intervention Type: PROCEDURE

a surgery for adenoid removal or reduction under general anesthesia using suction diathermy

Interventions

adenoidectomy - cold method

a surgery for adenoid removal or reduction under general anesthesia using surgical curretes

Intervention Type: PROCEDURE

adenoidectomy - hot method

a surgery for adenoid removal or reduction under general anesthesia using suction diathermy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Arie Gordin, MD

Head of pediatric otolaryngology division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0087-14-RMB

Identifier Type: -

Identifier Source: org_study_id