Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

University of Aarhus

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea; Tonsillar Hypertrophy

Treatments: Procedure: Tonsillotomy; Procedure: Tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06376383

TETT-RHG

110500 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity.

Enrollment: 464 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Tonsil size 2, 3, or 4 (Friedman tonsil scale)
• Confirmed OSA with sleep analysis not older than a year either CRM or PSG
• ASA 1 or 2
• BMI < 35 kg/m2

Exclusion criteria

Children age < 18 years

• Previous pharyngeal surgery such as previous tonsillotomy, tonsillectomy or palatal surgery
• Epileptic disease or severe neurological comorbidity.
• ASA 3, or 4.
• Central sleep apnea
• Previous thrombotic disease.
• Currently treated with sleep medications
• No collapse of oropharyngeal lateral wall during DISE
• Dropout of study, lack of sleep analysis or lack of postoperative DISE.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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464 participants in 2 patient groups

Tonsillectomy

Active Comparator group

Description:

Patients undergo standard removal of subcapsular removal of palatine tonsils

Treatment:

Procedure: Tonsillectomy

Tonsillotomy

Experimental group

Description:

Patients undergo intracapsular reduction of palatine tonsils

Treatment:

Procedure: Tonsillotomy