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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Procedure: Electrocautery-tonsillectomy; Procedure: Coblation-tonsillotomy	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (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
Study Start Date :	June 2008
Estimated Primary Completion Date :	June 2013
Estimated Study Completion Date :	June 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy [ Time Frame: 1 week post-op ]
2. Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA [ Time Frame: 6-8 weeks post-op ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Derek Drummond, University of Calgary
ClinicalTrials.gov Identifier:	NCT00694772 History of Changes
Other Study ID Numbers:	E-21417
First Posted:	June 10, 2008
Last Update Posted:	June 10, 2008
Last Verified:	June 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