RecruitingNot ApplicableNCT07577232

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

Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess - Proposal for a Multicenter Cluster Randomized Trial


Sponsor

Rigshospitalet, Denmark

Enrollment

368 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients referred to the ENT outpatient clinic with a suspected PTA.
  • years of age or older.

Exclusion Criteria3

  • Unable to understand the verbal information, participating in research.
  • Prior surgical interventions (needle aspiration, surgery, incision) during the course of the disease.
  • Compromised airways, needing acute airway management.

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Interventions

DEVICETransoral Ultrasound

A small hockey stick ultrasound to scan the oropharynx through the mouth


Locations(3)

Department of Otorhinolaryngology, Head and Neck Surgery & Audiolog

Copenhagen, Denmark

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

Hillerød, Denmark

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

Køge, Denmark

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NCT07577232


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