N/A N=30

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

Sleep-disordered Breathing · Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT00887471 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Median Change in Apnea-hypopnea Index (AHI) — 3.8; 8.0 events per hour of sleep — p=.590

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: PITA or T&A (Procedure)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: State University of New York - Downstate Medical Center
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Change in Apnea-hypopnea Index (AHI)	3.8; 8.0	.590
SECONDARY Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5	5; 4	1.00

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.

Eligibility Criteria

Inclusion Criteria

The medical records of 149 children who underwent partial intracapsular tonsillectomy and adenoidectomy at the State University of New York (SUNY) Downstate Medical Center or the Long Island College Hospital will be reviewed to identify children with positive preoperative polysomnography. 18 of those with positive preoperative studies 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 (Apnea Hypopnea Index Index within 5) to 18 children who underwent traditional tonsillectomy and adenoidectomy (out of a total of 455 patients).

Exclusion Criteria

Recurrent tonsillitis
Craniofacial syndromes
Neuromuscular disorders
Sickle cell disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00887471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.