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

December 20, 2013 updated by: State University of New York - Downstate Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Change in Apnea-hypopnea Index (AHI)
Time Frame: 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
Baseline and 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5
Time Frame: 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
Baseline and 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Downstate Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-095

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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