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Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Calgary.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Calgary
Collaborators:
ArthroCare Corporation
Calgary Health Region
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00694772
First received: June 6, 2008
Last updated: June 9, 2008
Last verified: June 2008
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Purpose
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 |
|---|---|
| Obstructive Sleep Apnea | Procedure: Electrocautery-tonsillectomy Procedure: Coblation-tonsillotomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study |
Resource links provided by NLM:
Further study details as provided by University of Calgary:
Primary Outcome Measures:
- 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) [ Time Frame: 6 months and 2 years post-op ]
Secondary Outcome Measures:
- Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy [ Time Frame: 1 week post-op ]
- Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA [ Time Frame: 6-8 weeks post-op ]
| 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 |
|---|---|
| Active Comparator: Electrocautery |
Procedure: Electrocautery-tonsillectomy
standard of care electrocautery tonsillectomy
|
| Experimental: Coblation |
Procedure: Coblation-tonsillotomy
use of Arthrocare Coblation Technology to perform tonsillotomy
Other Name: alternative procedure name: subcapsular tonsillectomy
|
Eligibility| Ages Eligible for Study: | 2 Years to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate or severe OSA on PSG (AHI ≥ 5.0)
- Pronounced tonsillar hyperplasia on physical exam
- No previous tonsil or adenoid surgery
- No history of recurrent tonsillitis
- Participants and their families must be willing to comply with follow-up
- Parents/caregivers fluent in English
Exclusion Criteria:
- Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00694772
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694772
Contacts
| Contact: Derek S Drummond, MD, MPH | (403) 955-2218 | dsdrummond@shaw.ca |
Locations
| 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 | |
Sponsors and Collaborators
University of Calgary
ArthroCare Corporation
Calgary Health Region
Investigators
| Principal Investigator: | Derek S Drummond, MD, MPH | University of Calgary |
More Information
| Responsible Party: | Derek Drummond, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00694772 History of Changes |
| Other Study ID Numbers: |
E-21417 |
| Study First Received: | June 6, 2008 |
| Last Updated: | June 9, 2008 |
Keywords provided by University of Calgary:
|
Obstructive sleep apnea OSA Apnea hypopnea index AHI |
Coblation Electrocautery Tonsillectomy Tonsillotomy |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on July 19, 2017