Brooklyn, New York 11203

  • Obstructive Sleep Apnea

Purpose:

The purpose of this study is to demonstrate similar improvements in sleep-disordered breathing as determined by sleep study with microdebrider-assisted partial intracapsular tonsillectomy and adenoidectomy versus total Bovie electrocautery tonsillectomy and adenoidectomy.


Study summary:

Objectives: To demonstrate similar improvement in sleep-disordered breathing as determined by polysomnography (PSG) with microdebrider-assisted partial intracapsular tonsillectomy and adenoidectomy (PITA) versus Bovie electrocautery complete tonsillectomy and adenoidectomy (T&A). Methods: In a retrospective cohort study children found to have Obstructive Sleep Apnea (OSA) by PSG who have undergone either PITA or T&A as treatment will be evaluated with repeat PSG. The groups will be matched by age, sex, and severity of pre-operative Apnea-Hypopnea Indices (AHI). The investigators performing and evaluating the PSG will be blinded to type of procedure and preoperative AHI. Change scores will be computed for each participant and the change scores of the groups compared.


Criteria:

Inclusion Criteria: - 18 of 127 children who underwent partial intracapsular tonsillectomy and adenoidectomy at SUNY Downstate Medical Center will be randomly selected and offered participation in the study. - Once enrolled, the participants will be matched by age, sex, time since procedure and polysomnography results (Respiratory Disturbance Index within 5) to 18 children who underwent traditional tonsillectomy and adenoidectomy at SUNY Downstate. Exclusion Criteria: - Recurrent tonsillitis - Craniofacial syndromes - Neuromuscular disorders - Sickle cell disease


NCT ID:

NCT00887471


Primary Contact:

Principal Investigator
Nira A Goldstein, MD
State University of New York - Downstate Medical Center


Backup Contact:

N/A


Location Contact:

Brooklyn, New York 11203
United States

Jason R Mangiardi, MD
Phone: 718-270-1282
Email: jaypgh@hotmail.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 07, 2022

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