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| Name | Class |
|---|---|
| ArthroCare Corporation | OTHER |
| Calgary Health Region | OTHER |
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Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocautery | Active Comparator |
| |
| Coblation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocautery-tonsillectomy | Procedure | standard of care electrocautery tonsillectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare coblation-tonsillotomy to electrocautery-tonsillectomy as a treatment of obstructive sleep apnea (OSA), as assessed by apnea-hypopnea index (AHI) measured on polysomnography (PSG) | 6 months and 2 years post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy | 1 week post-op | |
| Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek S Drummond, MD, MPH | Contact | (403) 955-2218 | dsdrummond@shaw.ca |
| Name | Affiliation | Role |
|---|---|---|
| Derek S Drummond, MD, MPH | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Coblation-tonsillotomy |
| Procedure |
use of Arthrocare Coblation Technology to perform tonsillotomy |
|
|
| 6-8 weeks post-op |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |