Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children

Study Overview
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Brief Summary
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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.

Official Title
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Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: Electrocautery-tonsillectomy
* Procedure: Coblation-tonsillotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electrocautery<br> | Procedure: Electrocautery-tonsillectomy<br>* standard of care electrocautery tonsillectomy<br>|
| Experimental: Coblation<br> | Procedure: Coblation-tonsillotomy<br>* use of Arthrocare Coblation Technology to perform tonsillotomy<br>* Other names: alternative procedure name: subcapsular tonsillectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 6-8 weeks post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AHI, Obstructive sleep apnea, OSA, Apnea hypopnea index, Coblation, Electrocautery, Tonsillectomy, Tonsillotomy