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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electrocautery-tonsillectomy
Coblation-tonsillotomy
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, OSA, Apnea hypopnea index, AHI, Coblation, Electrocautery, Tonsillectomy, Tonsillotomy

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Electrocautery

Coblation

Arm Description

Outcomes

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)

Secondary Outcome Measures

Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy
Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA

Full Information

First Posted
June 6, 2008
Last Updated
June 9, 2008
Sponsor
University of Calgary
Collaborators
ArthroCare Corporation, Calgary Health Region
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1. Study Identification

Unique Protocol Identification Number
NCT00694772
Brief Title
Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary
Collaborators
ArthroCare Corporation, Calgary Health Region

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, OSA, Apnea hypopnea index, AHI, Coblation, Electrocautery, Tonsillectomy, Tonsillotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrocautery
Arm Type
Active Comparator
Arm Title
Coblation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Electrocautery-tonsillectomy
Intervention Description
standard of care electrocautery tonsillectomy
Intervention Type
Procedure
Intervention Name(s)
Coblation-tonsillotomy
Other Intervention Name(s)
alternative procedure name: subcapsular tonsillectomy
Intervention Description
use of Arthrocare Coblation Technology to perform tonsillotomy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy
Time Frame
1 week post-op
Title
Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA
Time Frame
6-8 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derek S Drummond, MD, MPH
Phone
(403) 955-2218
Email
dsdrummond@shaw.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek S Drummond, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek S Drummond, MD, MPH
Phone
(403) 955-2218
Email
dsdrummond@shaw.ca
First Name & Middle Initial & Last Name & Degree
Derek S Drummond, MD, MPH
First Name & Middle Initial & Last Name & Degree
Warren K Yunker, MD, PhD
First Name & Middle Initial & Last Name & Degree
Valerie G Kirk, MD
First Name & Middle Initial & Last Name & Degree
David Lardner, MD

12. IPD Sharing Statement

Learn more about this trial

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

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