Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT

Not Applicable

• Conditions: Peritonsillar Abscess
• Interventions: Diagnostic Test: Intraoral ultrasound; Procedure: The landmark technique

• Registration Number: NCT03824288
• Lead Sponsor: Tobias Todsen

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20
• Primary Completion: 2019-08-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided aspiration	Intraoral ultrasound	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.
The landmark technique	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.

Primary Outcome Measures

Name	Time	Method
needle aspirations	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	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	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 Outcome Measures

Name	Time	Method
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.	Patients are asked to choose one number, on a scale from 0 (no pain) to 10 (severe pain), corresponding to the intensity of their pain - meassured using a 11-point numeric rating scale (NRS-11).
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.

Trial Locations

Locations (2)

Rigshospitalet; 🇩🇰 Copenhagen, Copenhagen East, Denmark

Odense University Hospital; 🇩🇰 Odense, Odense C, Denmark