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

Completed

• Conditions: Obstructive Sleep Apnea; Sleep-disordered Breathing
• Interventions: Procedure: PITA or T&A

• Registration Number: NCT00887471
• Lead Sponsor: State University of New York - Downstate Medical Center

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 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Primary Completion: 2009-10
• Study Completion: 2010-01
• Status Verified: 2012-06
• Results First Submitted: 2012-06-06
• Results First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Results First Posted: 2014-02-10
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children who underwent PITA	PITA or T&A	Children who underwent partial intracapsular tonsillectomy and adenoidectomy between July 2003 and January 2008 for treatment of pediatric sleep-disordered breathing documented by positive preoperative polysomnography.
Children who underwent T&A	PITA or T&A	Children who underwent total tonsillectomy and adenoidectomy between July 2003 and January 2008 for treatment of pediatric sleep-disordered breathing documented by positive preoperative polysomnography.

Primary Outcome Measures

Name	Time	Method
Median Change in Apnea-hypopnea Index (AHI)	Baseline and 4 years	Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5	Baseline and 4 years	Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study

Trial Locations

Locations (1)

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States