Status:
COMPLETED
Comparison of Sleep Study Results After Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy
Lead Sponsor:
State University of New York - Downstate Medical Center
Collaborating Sponsors:
American Society of Pediatric Otolaryngology
Conditions:
Sleep-disordered Breathing
Obstructive Sleep Apnea
Eligibility:
All Genders
6-14 years
Brief 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 adenoide...
Detailed Description
Objectives: To demonstrate similar improvement in sleep-disordered breathing as determined by polysomnography (PSG) with microdebrider-assisted partial intracapsular tonsillectomy and adenoidectomy (P...
Eligibility Criteria
Inclusion
- 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
- Recurrent tonsillitis
- Craniofacial syndromes
- Neuromuscular disorders
- Sickle cell disease
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00887471
Start Date
August 1 2006
End Date
January 1 2010
Last Update
February 10 2014
Active Locations (1)
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1
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203