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

June 9, 2008 updated by: University of Calgary

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • alternative procedure name: subcapsular tonsillectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months and 2 years post-op

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

ArthroCare Corporation
Calgary Health Region

Investigators

  • Principal Investigator: Derek S Drummond, MD, MPH, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (ESTIMATE)

June 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-21417

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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