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

University of Calgary

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: Coblation-tonsillotomy; Procedure: Electrocautery-tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00694772

E-21417

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Electrocautery

Active Comparator group

Treatment:

Procedure: Electrocautery-tonsillectomy

Coblation

Experimental group

Treatment:

Procedure: Coblation-tonsillotomy