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| Name | Class |
|---|---|
| American Society of Pediatric Otolaryngology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PITA or T&A | Procedure | PITA - Microdebrider-assisted Partial Intracapsular Tonsillectomy and Adenoidectomy T&A - Bove Electrocautery Complete Tonsillectomy and Adenoidectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5 | Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study | Baseline and 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20880595 | Result | 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. |
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Of these 15 PITA patients entered and completed the study and 15 matched T&A patients entered and completed the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Children Who Underwent PITA | Children who underwent partial intracapsular tonsillectomy and adenoidectomy. |
| FG001 | Children Who Underwent T&A | Children who underwent total tonsillectomy and adenoidectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children Who Underwent PITA | Children who underwent partial intracapsular tonsillectomy and adenoidectomy. |
| BG001 | Children Who Underwent T&A | Children who underwent total tonsillectomy and adenoidectomy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Standard Deviation | events per hour of sleep | Baseline and 4 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children Who Underwent PITA | Children who underwent partial intracapsular tonsillectomy and adenoidectomy. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nira A Goldstein, MD | SUNY Downsate Medical Center | 718-270-1638 | ngoldstein@downstate.edu |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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|
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| Secondary | Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5 | Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study | Posted | Number | participants | Baseline and 4 years |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Children Who Underwent T&A | Children who underwent total tonsillectomy and adenoidectomy. | 0 | 15 | 0 | 15 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |