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Sponsors and Collaborators: |
University of Calgary ArthroCare Corporation Calgary Health Region |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00694772 |
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.
Condition | Intervention |
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Obstructive Sleep Apnea |
Procedure: Electrocautery-tonsillectomy Procedure: Coblation-tonsillotomy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Electrocautery: Active Comparator |
Procedure: Electrocautery-tonsillectomy
standard of care electrocautery tonsillectomy
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Coblation: Experimental |
Procedure: Coblation-tonsillotomy
use of Arthrocare Coblation Technology to perform tonsillotomy
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Ages Eligible for Study: | 2 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Derek S Drummond, MD, MPH | (403) 955-2218 | dsdrummond@shaw.ca |
Canada, Alberta | |
Alberta Children's Hospital | Recruiting |
Calgary, Alberta, Canada, T3B 6A8 | |
Contact: Derek S Drummond, MD, MPH (403) 955-2218 dsdrummond@shaw.ca | |
Principal Investigator: Derek S Drummond, MD, MPH | |
Sub-Investigator: Warren K Yunker, MD, PhD | |
Sub-Investigator: Valerie G Kirk, MD | |
Sub-Investigator: David Lardner, MD |
Principal Investigator: | Derek S Drummond, MD, MPH | University of Calgary |
Responsible Party: | University of Calgary ( Derek Drummond ) |
Study ID Numbers: | E-21417 |
Study First Received: | June 6, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00694772 |
Health Authority: | Canada: Health Canada |
Obstructive sleep apnea OSA Apnea hypopnea index AHI |
Coblation Electrocautery Tonsillectomy Tonsillotomy |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Nervous System Diseases |