Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea; Tonsillar Hypertrophy
• Interventions: Procedure: Tonsillectomy; Procedure: Tonsillotomy

• Registration Number: NCT06376383
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Study Start: 2025-01
• Primary Completion: 2026-12
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 464

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tonsillectomy	Tonsillectomy	Patients undergo standard removal of subcapsular removal of palatine tonsils
Tonsillotomy	Tonsillotomy	Patients undergo intracapsular reduction of palatine tonsils

Primary Outcome Measures

Name	Time	Method
Postoperative pain	30 days	Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.
Recovery time - Sick leave	30 days	Sick-leave in days, measured when the patient is at work or back at school, day 0 = surgery day and outcome day is last day of sick-leave
Morbidity	30 days	Re-admission at the hospital. Event is registered as null if no re-admission occurs and 1 or 2 etc. if re-admission occurs within first 30 days after surgery
Postoperative hemorrhage	14 days	Postoperative hemorrhage event - readmission to the hospital

Secondary Outcome Measures

Name	Time	Method
AHI	180 days	Apnea Hypopnea Index before and after surgery. Increase in AHI means worsening in apnea hypopnea index. AHI is measured by performing at home type 3 sleep registration
DISE - VOTE	180 days	Velum Oropharyngeal Tongue base Epiglottis (VOTE) evaluation. 0 = no collaps; 1. = partial collaps; 2. = complete collaps