Clinical trial NCT03824288: Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
Official title: A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritonsillar Abscess
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2019-01-31
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)


Eligibility criteria: Inclusion criteria:

* Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
* Clinical findings of peritonsillar abscess by one of the following:

  1. Trismus
  2. 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

Primary outcomes:
measure: needle aspirations
timeFrame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
measure: proportion of succesfull needle aspirations
timeFrame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
measure: days on sick leave
timeFrame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Secondary outcomes:
measure: Number of hospitalization days
timeFrame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
measure: Number of quincy tonsillectomies
timeFrame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
measure: Number of visits in outpatient clinic
timeFrame: Until full recovery from peritonsilar infection
measure: Patient-reported outcome
timeFrame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Copenhagen East
city: Odense
country: Denmark
facility: Odense University Hospital
state: Odense C
Study officials:
References:
citation: 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.