Actively Recruiting

Phase Not Applicable
Age: 15Years +
All Genders
NCT06606262

Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Led by Tejs Ehlers Klug · Updated on 2024-12-19

250

Participants Needed

2

Research Sites

269 weeks

Total Duration

On this page

Sponsors

T

Tejs Ehlers Klug

Lead Sponsor

U

University of Aarhus

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE. Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain. Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.

CONDITIONS

Official Title

Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 15 years or older with recurrent tonsillitis, defined as at least five episodes in one year or at least three episodes per year for two years
  • Ability to understand Danish both orally and in writing
Not Eligible

You will not qualify if you...

  • Previous tonsillectomy or tonsillotomy
  • Suspected cancer in the tonsils
  • History of cancer in the mouth, throat, or voice box
  • Previous radiation therapy to the head or neck
  • Bleeding disorders or use of blood-thinning medications

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Aalborg University Hospital

Aalborg, Denmark, 9000

Actively Recruiting

2

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

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Research Team

H

Hannah Inez Houborg, MD

CONTACT

T

Tejs Ehlers Klug, MD, DMSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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