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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by University of Calgary.
Recruitment status was Recruiting

Sponsor:

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

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy [ Time Frame: 1 week post-op ] [ Designated as safety issue: No ]
Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA [ Time Frame: 6-8 weeks post-op ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority:	Canada: Health Canada

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 September 26, 2016

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