Recruiting

Coblation-Tonsillotomy vs. Electrocautery-Tonsillectomy

Sponsor:

University of Calgary

Code:

NCT00694772

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 2 - 8

Healthy Volunteers: Not accepted

Interventions

Electrocautery-tonsillectomy

Coblation-tonsillotomy

Study Details

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

Study ID

NCT00694772

Start date

Jun, 2008

Status verified date

Jun, 2008

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 8

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Electrocautery

experimental: Coblation

Interventions

Electrocautery-tonsillectomy

standard of care electrocautery tonsillectomy

Coblation-tonsillotomy

use of Arthrocare Coblation Technology to perform tonsillotomy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Derek S Drummond, MD, MPH

(403) 955-2218dsdrummond@shaw.ca

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Derek S Drummond, MD, MPH

(403) 955-2218dsdrummond@shaw.ca

Principal Investigator:

Derek S Drummond, MD, MPH

More Information

Sponsor

University of Calgary

Last update posted

Jun 10, 2008

Last verified

Jun, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2008-06-10.