Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
1 other identifier
interventional
88
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2018
CompletedFirst Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedAugust 20, 2019
August 1, 2019
9 months
January 23, 2019
August 19, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
needle aspirations
total number of needle aspirations performed
From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
proportion of succesfull needle aspirations
proportion of needle aspirations with aspiration of pus
From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
days on sick leave
Total number of days on sick leave after first intervention
From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Secondary Outcomes (4)
Number of hospitalization days
From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Number of quincy tonsillectomies
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
Patient-reported outcome
From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Study Arms (2)
The landmark technique
ACTIVE COMPARATORPTA 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.
Ultrasound-guided aspiration
EXPERIMENTALAn 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.
Interventions
The ultrasound transducer (either Hockey Stick or Burr-Hole N11C5s transducer from BK Ultrasound) is placed on the palatoglossal arch on the affected side and sweeped from the cranial to caudal end of the tonsil to look for an abscess cavity identified as a hypoechoic area with ill-defined margins.
A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
Eligibility Criteria
You may qualify if:
- Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
- Clinical findings of peritonsillar abscess by one of the following:
- Trismus
- Unilateral tonsillar/peritonsillar swelling
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tobias Todsenlead
- Odense University Hospitalcollaborator
Study Sites (2)
Rigshospitalet
Copenhagen, Copenhagen East, 2100, Denmark
Odense University Hospital
Odense, Odense C, 5000, Denmark
Related Publications (1)
Todsen T, Stage MG, Michaelsen SH, Tolsgaard MG, Melchiors J, Madsen AR, Hahn CH, Godballe C. Protocol for a randomised clinical trial of transoral ultrasound versus standard of care in the diagnosis of peritonsillar abscess. Dan Med J. 2019 Nov;66(11):A5573.
PMID: 31686648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 31, 2019
Study Start
November 26, 2018
Primary Completion
August 30, 2019
Study Completion
April 30, 2020
Last Updated
August 20, 2019
Record last verified: 2019-08