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

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ClinicalTrials.gov Identifier: NCT00694772
Recruitment Status : Unknown
Verified June 2008 by University of Calgary.
Recruitment status was:  Recruiting
First Posted : June 10, 2008
Last Update Posted : June 10, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
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
Obstructive Sleep Apnea Procedure: Electrocautery-tonsillectomy Procedure: Coblation-tonsillotomy

Study Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 10, 2008    Key Record Dates
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