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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by State University of New York - Downstate Medical Center. Recruitment status was Recruiting

First Received on March 28, 2008. Last Updated on April 23, 2009 History of Changes

Sponsor:	State University of New York - Downstate Medical Center
Collaborator:	American Society of Pediatric Otolaryngology
Information provided by:	State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:	NCT00887471

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 Total

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:

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids

U.S. FDA Resources

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

Estimated Enrollment:	36
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009

Groups/Cohorts	Assigned Interventions
1 Children who underwent partial intracapsular tonsillectomy and adenoidectomy.	Procedure: PITA or Total
2 Children who underwent total intracapsular tonsillectomy and adenoidectomy.	Procedure: PITA or Total

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

Criteria

Inclusion Criteria:

18 of 127 children who underwent partial intracapsular tonsillectomy and adenoidectomy at SUNY Downstate Medical Center 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 (Respiratory Disturbance Index within 5) to 18 children who underwent traditional tonsillectomy and adenoidectomy at SUNY Downstate.

Exclusion Criteria:

Recurrent tonsillitis
Craniofacial syndromes
Neuromuscular disorders
Sickle cell disease

Contacts and Locations

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

Locations

United States, New York
SUNY Downstate Medical Center	Recruiting
Brooklyn, New York, United States, 11203
Contact: Jason R Mangiardi, MD 718-270-1282 jaypgh@hotmail.com
Contact: Nira A Goldstein, MD 718-270-1638 ngoldstein@downstate.edu
Principal Investigator: Nira A Goldstein, MD
Sub-Investigator: Jason R Mangiardi, MD
Sub-Investigator: Madu Rao, MD

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

No publications provided by State University of New York - Downstate Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Sep 28.

Responsible Party:	Robin Nesby, The Research Foundation of the State University of New York
ClinicalTrials.gov Identifier:	NCT00887471 History of Changes
Other Study ID Numbers:	06-095
Study First Received:	March 28, 2008
Last Updated:	April 23, 2009
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:

Apnea
Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012