Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 464
- Primary Endpoint
- Postoperative pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 30 days
Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.
Recovery time - Sick leave
Time Frame: 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
Time Frame: 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
Time Frame: 14 days
Postoperative hemorrhage event - readmission to the hospital
Secondary Outcomes
- AHI(180 days)
- DISE - VOTE(180 days)