Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

April 18, 2024 updated by: University of Aarhus

Tonsillectomy Versus Tonsillotomy in Adults With Obstructive Sleep Apnea; a Randomized Controlled Trial Comparing Postoperative Morbidity

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

464

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kasra Zainali-Gill, Ph.D
  • Phone Number: +4578439744
  • Email: kasrzain@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tonsillectomy
Patients undergo standard removal of subcapsular removal of palatine tonsils
Procedure: Tonsillectomy
Standard tonsillectomy
Other Names:
  • TE
Experimental: Tonsillotomy
Patients undergo intracapsular reduction of palatine tonsils
Procedure: Tonsillotomy
Tonsillotomy
Other Names:
  • TT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hemorrhage
Time Frame: 14 days
Postoperative hemorrhage event - readmission to the hospital
14 days
Postoperative pain
Time Frame: 30 days
Postoperative pain self-assed daily by using Visual Analoge Scale (VAS) 0 = No pain, 10 = maximal pain.
30 days
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
30 days
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AHI
Time Frame: 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
180 days
DISE - VOTE
Time Frame: 180 days

Velum Oropharyngeal Tongue base Epiglottis (VOTE) evaluation. 0 = no collaps

  1. = partial collaps
  2. = complete collaps
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TETT-RHG
  • 110500 (Other Identifier: The Central Denmark Region Committees on Health Research Ethics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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