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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
Enrollment 30
Recruitment Details 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 Of these 15 PITA patients entered and completed the study and 15 matched T&A patients entered and completed the study.
Arm/Group Title Children Who Underwent PITA Children Who Underwent T&A
Hide Arm/Group Description Children who underwent partial intracapsular tonsillectomy and adenoidectomy. Children who underwent total tonsillectomy and adenoidectomy.
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Children Who Underwent PITA Children Who Underwent T&A Total
Hide Arm/Group Description Children who underwent partial intracapsular tonsillectomy and adenoidectomy. Children who underwent total tonsillectomy and adenoidectomy. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
15
 100.0%
15
 100.0%
30
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
5.33  (3.65) 6.15  (3.29) 5.74  (3.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
3
  20.0%
8
  53.3%
11
  36.7%
Male
12
  80.0%
7
  46.7%
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Median Change in Apnea-hypopnea Index (AHI)
Hide Description 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
Time Frame Baseline and 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children Who Underwent PITA Children Who Underwent T&A
Hide Arm/Group Description:
Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
Children who underwent total tonsillectomy and adenoidectomy.
Overall Number of Participants Analyzed 15 15
Median (Standard Deviation)
Unit of Measure: events per hour of sleep
3.8  (8.5) 8.0  (18.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children Who Underwent PITA, Children Who Underwent T&A
Comments The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .590
Comments A priori threshold for statistical significance was P<.05.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Children Who Underwent PITA, Children Who Underwent T&A
Comments A mixed linear model was constructed as described above. Variance was estimated separately for each group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .022
Comments P value for the variances. The a priori threshold for statistical significance was P < .05.
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5
Hide Description Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study
Time Frame Baseline and 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Children Who Underwent PITA Children Who Underwent T&A
Hide Arm/Group Description:
Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
Children who underwent total tonsillectomy and adenoidectomy.
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children Who Underwent PITA, Children Who Underwent T&A
Comments The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Children Who Underwent PITA Children Who Underwent T&A
Hide Arm/Group Description Children who underwent partial intracapsular tonsillectomy and adenoidectomy. Children who underwent total tonsillectomy and adenoidectomy.
All-Cause Mortality
Children Who Underwent PITA Children Who Underwent T&A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Children Who Underwent PITA Children Who Underwent T&A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Children Who Underwent PITA Children Who Underwent T&A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
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.
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
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