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

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ClinicalTrials.gov Identifier: NCT00887471
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
American Society of Pediatric Otolaryngology
Information provided by (Responsible Party):
State University of New York - Downstate Medical Center

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Sleep-disordered Breathing
Obstructive Sleep Apnea
Intervention: Procedure: PITA or T&A

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Review of surgical case logs identified 45 patients with positive polysomnography (PSG) (laboratory-based, home or nap)who had undergone PITA and 101 with positive PSG who had undergone T&A.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of these 15 PITA patients entered and completed the study and 15 matched T&A patients entered and completed the study.

Reporting Groups
  Description
Children Who Underwent PITA Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
Children Who Underwent T&A Children who underwent total tonsillectomy and adenoidectomy.

Participant Flow:   Overall Study
    Children Who Underwent PITA   Children Who Underwent T&A
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Children Who Underwent PITA Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
Children Who Underwent T&A Children who underwent total tonsillectomy and adenoidectomy.
Total Total of all reporting groups

Baseline Measures
   Children Who Underwent PITA   Children Who Underwent T&A   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
     
<=18 years   15   15   30 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.33  (3.65)   6.15  (3.29)   5.74  (3.44) 
Gender 
[Units: Participants]
     
Female   3   8   11 
Male   12   7   19 
Region of Enrollment 
[Units: Participants]
     
United States   15   15   30 


  Outcome Measures

1.  Primary:   Median Change in Apnea-hypopnea Index (AHI)   [ Time Frame: Baseline and 4 years ]

2.  Secondary:   Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5   [ Time Frame: Baseline and 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nira A Goldstein, MD
Organization: SUNY Downsate Medical Center
phone: 718-270-1638
e-mail: ngoldstein@downstate.edu


Publications of Results:

Responsible Party: State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT00887471     History of Changes
Other Study ID Numbers: 06-095
First Submitted: March 28, 2008
First Posted: April 24, 2009
Results First Submitted: June 6, 2012
Results First Posted: February 10, 2014
Last Update Posted: February 10, 2014