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Cold Versus Hot Adenoidectomy for Obstructive Sleep Apnea in Pediatric Patients

NCT03760341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-09-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

adenoidectomy - cold method

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

PROCEDURE

adenoidectomy - hot method

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

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2018-08-30
Completion
2019-03-20

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760341 on ClinicalTrials.gov