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

NCT ID: NCT00887471

Last Updated: 2014-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Sleep-disordered Breathing Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PITA or T&A

Intervention Type PROCEDURE

PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T\&A - Bove Electrocautery Complete 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.

PITA or T&A

Intervention Type PROCEDURE

PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T\&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy

Interventions

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PITA or T&A

PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T\&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy

Intervention Type PROCEDURE

Other Intervention Names

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PITA = Partial Intracapsular Tonsillectomy and Adenoidectomy T&A = Tonsillectomy and Adenoidectomy

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Pediatric Otolaryngology

OTHER

Sponsor Role collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nira A Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Jason R Mangiardi, MD

Role: STUDY_DIRECTOR

State University of New York - Downstate Medical Center

Locations

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SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20880595 (View on PubMed)

Other Identifiers

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06-095

Identifier Type: -

Identifier Source: org_study_id

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