Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07577232

Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess

Led by Rigshospitalet, Denmark · Updated on 2026-05-11

368

Participants Needed

3

Research Sites

55 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound. Methods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool. Participants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces. The primary outcome is the diagnostic accuracy The investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.

CONDITIONS

Official Title

Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred to the ENT outpatient clinic with a suspected PTA.
  • 18 years of age or older.
Not Eligible

You will not qualify if you...

  • Unable to understand verbal information related to the study.
  • Previous surgical treatments (needle aspiration, surgery, incision) during this illness.
  • Airway problems requiring urgent airway management.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Department of Otorhinolaryngology, Head and Neck Surgery & Audiolog

Copenhagen, Denmark, 2100

Actively Recruiting

2

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, North Zealand Hospital

Hillerød, Denmark

Actively Recruiting

3

Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital,

Køge, Denmark

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess | DecenTrialz