NCT00887471

Comparison of Sleep Study Results After Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy

Comparison of Polysomnography Outcomes for Microdebrider-assisted Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: State University of New York - Downstate Medical Center · Academic / Other
• Sex: All
• Age: 6 Months – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep-disordered Breathing
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
PROCEDURE	PITA or T&A	PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T\&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-10-01
• Completion: 2010-01-01
• First posted: 2009-04-24
• Last updated: 2014-02-10
• Results posted: 2014-02-10

Locations

1 site across 1 country: United States