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

This study has been completed.
Sponsor:
Collaborator:
American Society of Pediatric Otolaryngology
Information provided by (Responsible Party):
State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:
NCT00887471
First received: March 28, 2008
Last updated: December 20, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention
Sleep-disordered Breathing
Obstructive Sleep Apnea
Procedure: PITA or T&A

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Polysomnography Outcomes for Microdebrider-assisted Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy

Resource links provided by NLM:


Further study details as provided by State University of New York - Downstate Medical Center:

Primary Outcome Measures:
  • Median Change in Apnea-hypopnea Index (AHI) [ Time Frame: Baseline and 4 years ] [ Designated as safety issue: No ]
    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:
  • Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5 [ Time Frame: Baseline and 4 years ] [ Designated as safety issue: No ]
    Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study


Enrollment: 30
Study Start Date: August 2006
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children who underwent PITA
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.
Procedure: PITA or T&A
PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy
Other Names:
  • PITA = Partial Intracapsular Tonsillectomy and Adenoidectomy
  • T&A = Tonsillectomy and Adenoidectomy
Children who underwent 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.
Procedure: PITA or T&A
PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy
Other Names:
  • PITA = Partial Intracapsular Tonsillectomy and Adenoidectomy
  • T&A = 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.

  Eligibility

Ages Eligible for Study:   6 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children treated at the SUNY Downstate Medical Center or the Long Island College Hospital in Brooklyn, NY for sleep-disordered breathing documented by positive polysomnography by either Partial Intracapsular Tonsillectomy and Adenoidectomy or complete Tonsillectomy and Adenoidectomy between 2003 and 2008.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887471

Locations
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
State University of New York - Downstate Medical Center
American Society of Pediatric Otolaryngology
Investigators
Principal Investigator: Nira A Goldstein, MD State University of New York - Downstate Medical Center
Study Director: Jason R Mangiardi, MD State University of New York - Downstate Medical Center
  More Information

Publications:
Responsible Party: State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT00887471     History of Changes
Other Study ID Numbers: 06-095
Study First Received: March 28, 2008
Results First Received: June 6, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Downstate Medical Center:
Sleep-disordered breathing
Obstructive sleep apnea
Polysomnography
Tonsillectomy
Microdebrider assisted partial intracapsular tonsillectomy

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014