Clinical trial NCT06376383: Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea
Official title: Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Tonsillar Hypertrophy
Keywords: Tonsillectomy
Obstructive sleep apnea (OSA)
Tonsillotomy
Intracapsular reduction of tonsils
Drug Induced Sedation Endoscopy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative hemorrhage
timeFrame: 14 days
measure: Postoperative pain
timeFrame: 30 days
measure: Recovery time - Sick leave
timeFrame: 30 days
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
measure: AHI
timeFrame: 180 days
measure: DISE - VOTE
timeFrame: 180 days
Other outcomes:
Locations:
Study officials:
References:
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