Obstructive Sleep Apnea, Tonsillar Hypertrophy
Conditions
Keywords
Tonsillectomy, Obstructive sleep apnea (OSA), Tonsillotomy, Intracapsular reduction of tonsils, Drug Induced Sedation Endoscopy
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.
Interventions
PROCEDURETonsillectomy
Standard tonsillectomy
PROCEDURETonsillotomy
Tonsillotomy
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hemorrhage | 14 days | Postoperative hemorrhage event - readmission to the hospital |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactKasra Zainali-Gill, Ph.D
Outcome results
None listed