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

Tracking Information

First Received Date ^ICMJE

June 6, 2008

Last Updated Date

June 9, 2008

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00694772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

Procedure: Electrocautery-tonsillectomy
Procedure: Coblation-tonsillotomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 8 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Derek S Drummond, MD, MPH

(403) 955-2218

dsdrummond@shaw.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00694772

Responsible Party

Derek Drummond, University of Calgary

Study ID Numbers ^ICMJE

E-21417

Study Sponsor ^ICMJE

University of Calgary

Collaborators ^ICMJE

ArthroCare Corporation
Calgary Health Region

Investigators ^ICMJE

Principal Investigator:

Derek S Drummond, MD, MPH

University of Calgary

Information Provided By

University of Calgary

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP