Comparison of Sleep Study Results After Partial Intracapsular Tonsillectomy Versus Total Tonsillectomy - NCT00887471-11203 (Clinical Trial 288686)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy288686.aspx
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Brooklyn |
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State:
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NY |
| Zip Code: |
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11203 |
| Conditions: |
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Sleep-Disordered Breathing - Obstructive Sleep Apnea |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 18 of 127 children who underwent partial intracapsular tonsillectomy and
adenoidectomy at SUNY Downstate Medical Center 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 (Respiratory Disturbance Index within 5) to 18 children who
underwent traditional tonsillectomy and adenoidectomy at SUNY Downstate.
Exclusion Criteria:
- Recurrent tonsillitis
- Craniofacial syndromes
- Neuromuscular disorders
- Sickle cell disease |
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| Study is available at: |
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SUNY Downstate Medical Center
Brooklyn, NY 11203
United States
Primary Contact:
Jason R Mangiardi, MD
Email: jaypgh@hotmail.com
Phone: 718-270-1282 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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