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

NCT00694772 | Unknown

• 1 other identifier: E-21417
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (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)

  6 months and 2 years post-op

Secondary Outcomes (2)

• Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy

  1 week post-op

• Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA

  6-8 weeks post-op

Study Arms (2)

Electrocautery

ACTIVE COMPARATOR

Procedure: Electrocautery-tonsillectomy

Coblation

EXPERIMENTAL

Procedure: Coblation-tonsillotomy

Interventions

Electrocautery-tonsillectomy PROCEDURE

standard of care electrocautery tonsillectomy

Electrocautery

Coblation-tonsillotomy PROCEDURE

use of Arthrocare Coblation Technology to perform tonsillotomy

Also known as: alternative procedure name: subcapsular tonsillectomy

Coblation

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay

Sponsors & Collaborators

• University of Calgary: lead
• ArthroCare Corporation: collaborator
• Calgary Health Region: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Derek S Drummond, MD, MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek S Drummond, MD, MPH

CONTACT

(403) 955-2218; dsdrummond@shaw.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

CA (1)