A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- needle aspirations
Study Overview
Brief Summary
The study is a prospective randomized controlled trial conducted at two different centers at the Department of ORL - Head & Neck Surgery, Odense University Hospital and the Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet.
The research question is:
In a group of patients referred to an otolaryngology department with objective findings of peritonsillar abscess, what are the effects of using intraoral ultrasound to diagnose and guide needle aspiration compared to the traditional landmark-based technique, when measured by the number of performed needle aspirations, procedure-related pain and days on sick leave?
The secondary outcomes measured are
- Number of hospitalization days
- Number of Quincy tonsillectomies
- Number of visits to an outpatient clinic
- Patient-reported outcome (measured using an 11-point numeric rating scale)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
- •Clinical findings of peritonsillar abscess by one of the following:
- •Unilateral tonsillar/peritonsillar swelling
Exclusion Criteria
- •Compromised airways or suspected retro / parapharyngeal abscess
- •Needle aspiration of pus already performed (or participated in the study once earlier)
- •Cannot understand the written information
Arms & Interventions
The landmark technique
PTA a needle aspiration attempted according to the landmark technique is conducted. If the initial aspiration is unsuccessful, two additional attempts are made in the middle and lower pole of the tonsil.
Intervention: The landmark technique (Procedure)
Ultrasound-guided aspiration
An intraoral ultrasound is conducted with a Burr-Hole N11C5s transducer (BK Ultrasound) and if an abscess cavity is suspected, an ultrasound-guided aspiration is performed with an in-plane needle guide attached to guide the needle.
Intervention: Intraoral ultrasound (Diagnostic Test)
Outcomes
Primary Outcomes
needle aspirations
Time Frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
total number of needle aspirations performed
proportion of succesfull needle aspirations
Time Frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
proportion of needle aspirations with aspiration of pus
days on sick leave
Time Frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Total number of days on sick leave after first intervention
Secondary Outcomes
- Number of hospitalization days(From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.)
- Patient-reported outcome(From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.)
- Number of visits in outpatient clinic(Until full recovery from peritonsilar infection)
- Number of quincy tonsillectomies(From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.)
Investigators
Tobias Todsen
MD, PhD
Rigshospitalet, Denmark