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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887471
• Other study ID #: 06-095
• Status: Completed
• Phase: N/A
• First received: March 28, 2008
• Last updated: December 20, 2013
• Start date: August 2006
• Est. completion date: January 2010

Study information

• Verified date: June 2012
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 14 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Sleep-disordered Breathing

Intervention

Procedure:
• PITA or T&A
PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center	American Society of Pediatric Otolaryngology

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mangiardi J, Graw-Panzer KD, Weedon J, Regis T, Lee H, Goldstein NA. Polysomnography outcomes for partial intracapsular versus total tonsillectomy. Int J Pediatr Otorhinolaryngol. 2010 Dec;74(12):1361-6. doi: 10.1016/j.ijporl.2010.09.003. Epub 2010 Sep 28 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Change in Apnea-hypopnea Index (AHI)	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	Baseline and 4 years	No
Secondary	Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5	Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study	Baseline and 4 years	No