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

NCT ID: NCT00694772

Last Updated: 2008-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Keywords

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Obstructive sleep apnea OSA Apnea hypopnea index AHI Coblation Electrocautery Tonsillectomy Tonsillotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Electrocautery

Group Type ACTIVE_COMPARATOR

Electrocautery-tonsillectomy

Intervention Type PROCEDURE

standard of care electrocautery tonsillectomy

Coblation

Group Type EXPERIMENTAL

Coblation-tonsillotomy

Intervention Type PROCEDURE

use of Arthrocare Coblation Technology to perform tonsillotomy

Interventions

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Electrocautery-tonsillectomy

standard of care electrocautery tonsillectomy

Intervention Type PROCEDURE

Coblation-tonsillotomy

use of Arthrocare Coblation Technology to perform tonsillotomy

Intervention Type PROCEDURE

Other Intervention Names

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alternative procedure name: subcapsular tonsillectomy

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ArthroCare Corporation

OTHER

Sponsor Role collaborator

Calgary Health Region

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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University of Calgary

Principal Investigators

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Derek S Drummond, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Derek S Drummond, MD, MPH

Role: CONTACT

Phone: (403) 955-2218

Email: [email protected]

Facility Contacts

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Derek S Drummond, MD, MPH

Role: primary

Other Identifiers

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E-21417

Identifier Type: -

Identifier Source: org_study_id