NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
| NCT ID | NCT07577232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Rigshospitalet |
| Condition | Peritonsillar Abscess |
| Study Type | INTERVENTIONAL |
| Enrollment | 368 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 368 participants in total. It began in 2025-06-09 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Patients referred to the ENT outpatient clinic with a suspected PTA. * 18 years of age or older. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT07577232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peritonsillar Abscess. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07577232 currently recruiting?
Yes, NCT07577232 is actively recruiting participants. Visit ClinicalTrials.gov or contact Copenhagen University Hospital, Rigshospitalet to inquire about joining.
Where is the NCT07577232 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Hillerød, Denmark, Køge, Denmark.
Who is sponsoring the NCT07577232 clinical trial?
NCT07577232 is sponsored by Copenhagen University Hospital, Rigshospitalet. The trial plans to enroll 368 participants.