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

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: Electrocautery-tonsillectomy; Procedure: Coblation-tonsillotomy

• Registration Number: NCT00694772
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-06
• Study Start: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Last Update Submitted: 2008-06-09
• Study First Posted: 2008-06-10
• Last Update Posted: 2008-06-10
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrocautery	Electrocautery-tonsillectomy	-
Coblation	Coblation-tonsillotomy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada