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

NCT00887471 | Completed Results

• 1 other identifier: 06-095
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep-disordered Breathing; Obstructive Sleep Apnea

Keywords

Sleep-disordered breathing; Obstructive sleep apnea; Polysomnography; Tonsillectomy; Microdebrider assisted partial intracapsular tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5

  Baseline and 4 years

Study Arms (2)

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

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

Interventions

PITA or T&A PROCEDURE

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

Also known as: PITA = Partial Intracapsular Tonsillectomy and Adenoidectomy, T&A = Tonsillectomy and Adenoidectomy

Children who underwent PITA; Children who underwent T&A

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Recurrent tonsillitis
• Craniofacial syndromes
• Neuromuscular disorders
• Sickle cell disease

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead
• American Society of Pediatric Otolaryngology: collaborator

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Related 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.

  PMID: 20880595 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Selection bias, sample size limitation as it the study was not powered to detect small differences between the groups, and the use of unattended home PSG instead of laboratory-based PSG.

Results Point of Contact

• Title: Nira A Goldstein, MD
• Organization: SUNY Downsate Medical Center

ngoldstein@downstate.edu

718-270-1638

Study Officials

• Nira A Goldstein, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

• Jason R Mangiardi, MD

  State University of New York - Downstate Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 24, 2009
• Study Start: August 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 10, 2014
• Results First Posted: February 10, 2014

Record last verified: 2012-06

Locations

US (1)