Health TrialsbyHealthPanel

Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

ConditionsObstructive Sleep ApneaTonsillar Hypertrophy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Aarhus

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous pharyngeal surgery such as previous tonsillotomy, tonsillectomy or palatal surgery

Epileptic disease or severe neurological comorbidity.

ASA 3, or 4.

Central sleep apnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tonsillectomy

    Procedure/Surgery

    Standard tonsillectomy

  • Tonsillotomy

    Procedure/Surgery

    Tonsillotomy

Treatment groups

464 Participants
are divided into 2 treatment groups
Group A: TonsillectomyActive comparator 1 intervention
Group B: TonsillotomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative hemorrhage

Postoperative hemorrhage event - readmission to the hospital

Time frame
14 days
2

Postoperative pain

Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.

Time frame
30 days
3

Recovery time - Sick leave

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

Time frame
30 days
4

Morbidity

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

Time frame
30 days

Secondary outcomes

1

AHI

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

Time frame
180 days
2

DISE - VOTE

Velum Oropharyngeal Tongue base Epiglottis (VOTE) evaluation. 0 = no collaps 1. = partial collaps 2. = complete collaps

Time frame
180 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: