MedTrace Logo

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

NCT00694772 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-06-10

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Electrocautery-tonsillectomy

standard of care electrocautery tonsillectomy

PROCEDURE

Coblation-tonsillotomy

use of Arthrocare Coblation Technology to perform tonsillotomy

Sponsors & Collaborators

  • ArthroCare Corporation

    collaborator OTHER

  • Calgary Health Region

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Derek S Drummond, MD, MPH · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694772 on ClinicalTrials.gov