Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Turku University Hospital (TYKS)

Status: Completed

Conditions: Sleep Apnea, Obstructive; Tonsillar Hypertrophy

Treatments: Procedure: Tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04314492

T62/2020

Details and patient eligibility

About

Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation

Full description

The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.

Enrollment: 25 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 16-64
• Planned tonsil surgery with informed concent
• Obstructive sleep apnea (AHI > 15)
• Tonsillar size of 3-4 on the Friedman scale

Exclusion criteria

• BMI > 35 (Based on finnish Käypä Hoito -recommendations)
• Central sleep apnea
• Weight loss of more than 10% within the study period
• Untreated obstruction of nasal breathing
• Treated peritonsillar abscess <1 month before enrollment
• Active tonsillar infection
• Previous tonsillar surgery (excluding incision of abscess)
• Malignancy
• High use of analgesics >1 DDD daily during last 4 weeks
• Untreated reflux
• Anticoagulative medication
• Any condition of hemophilia
• Pregnancy, lactation
• Other, evaluated by treating physician

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intracapsular tonsillectomy with coblation

Experimental group

Description:

(Total) Intracapsular tonsillectomy (ICTE) with coblation

Treatment:

Procedure: Tonsillectomy