Actively Recruiting
Transoral Ultrasound Versus No Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess A Multicenter Cluster Randomized Trial
Led by Rigshospitalet, Denmark · Updated on 2026-05-11
368
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using transoral ultrasound improves the diagnostic accuracy for patients suspected of having a peritonsillar abscess (PTA). PTA is a collection of pus near the tonsil causing pain and swelling, and it can be difficult to distinguish from peritonsillar cellulitis or tonsillitis by clinical examination alone. This multicenter cluster randomized trial compares traditional clinical examination with and without transoral ultrasound to see which method better identifies PTA and reduces unnecessary procedures. The study involves two groups: one receiving clinical examination combined with transoral ultrasound performed by a head and neck surgeon using a small hockey stick ultrasound probe placed inside the mouth, and the other receiving only the standard clinical examination including visual inspection and fiberoptic laryngoscopy. If PTA is suspected, needle aspiration to drain pus is performed, guided by ultrasound in the intervention group. Patients are randomized weekly by clinic visit week to either group. The trial runs from June 2025 to June 2026 at multiple hospitals. Participants are patients 18 years or older referred to outpatient ENT clinics with suspected PTA. During their first visit, clinical data, examination findings, and treatment details are recorded. Follow-up includes tracking diagnostic accuracy, number of surgical procedures, needle aspirations, hospital visits, and admissions over up to two months. The study monitors whether ultrasound use leads to fewer missed abscesses and fewer unnecessary aspirations, aiming to improve standard diagnostic care for PTA.
CONDITIONS
Brief Title
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients referred to the ENT outpatient clinic with a suspected peritonsillar abscess.
- 18 years of age or older.
You will not qualify if you...
- Unable to understand the verbal information needed to participate in research.
- Prior surgical interventions such as needle aspiration or surgery during the course of the disease.
- Compromised airways requiring acute airway management.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Same day as outpatient clinic visit
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the outpatient clinic for initial clinical examination and eligibility assessment
Duration - Day 1 (initial outpatient clinic visit)
Participants receive a clinical examination with or without transoral ultrasound depending on their randomization group to diagnose a suspected peritonsillar abscess.
1 visit (in-person) for clinical examination; transoral ultrasound performed for participants randomized to the ultrasound group
Duration - Up to 2 months or until treatment is completed
Participants receive treatment according to the diagnostic findings, including needle aspiration (ultrasound-guided if applicable), antibiotics, or surgery if needed.
Follow-up visits as needed during treatment period, including possible 24-48 hour follow-up visit
Duration - Up to 2 months after initial visit
Participants are monitored through medical records and outpatient visits to assess diagnostic accuracy and treatment outcomes.
Additional outpatient visits as needed based on clinical judgement; monitoring through medical chart review
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
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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