TY - JOUR

T1 - Protocol for a randomised clinical trial of transoral ultrasound versus standard of care in the diagnosis of peritonsillar abscess

AU - Todsen, Tobias

AU - Stage, Mads Georg

AU - Michaelsen, Sanne Høxbroe

AU - Tolsgaard, Martin G

AU - Melchiors, Jacob

AU - Madsen, Anders Rørbæk

AU - Hahn, Christoffer Holst

AU - Godballe, Christian

N1 - Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

PY - 2019

Y1 - 2019

N2 - INTRODUCTION: Peritonsillar infection is a common complication to acute tonsillitis in younger adults. If peritonsillar cellulitis progresses to a peritonsillar abscess (PTA), the primary treatment is surgical drainage. But distinguishing cellulitis from PTA on a standard clinical examination is difficult. This trial aims to explore whether point-of-care transoral ultrasound can improve diagnostic accuracy and guide successful needle aspiration in patients referred with PTA.METHODS: A randomised, controlled multicentre trial will be conducted at the departments of otorhinolaryngology, head and neck surgery at Rigshospitalet and Odense University Hospital. Patients referred with PTA will be randomised to either standard clinical examination (control) or standard clinical examination with supplemental transoral ultrasound (intervention). The diagnostic accuracy, the total number of performed needle aspirations and the proportion of successful needle aspirations will be compared between the two groups. The difference will be evaluated using binary logistic regression and a generalised estimating equation to adjust for clustering of data within each physician and each hospital. A total of 88 patients are necessary to measure the clinical effect of adding transoral ultrasound.CONCLUSIONS: This study will explore the clinical benefits of adding transoral ultrasound to the diagnostic work-up of patients with peritonsillar infections.FUNDING: The Rigshospitalet and Odense University Hospital Foundation.TRIAL REGISTRATION: Clinicaltrials NCT03824288.

AB - INTRODUCTION: Peritonsillar infection is a common complication to acute tonsillitis in younger adults. If peritonsillar cellulitis progresses to a peritonsillar abscess (PTA), the primary treatment is surgical drainage. But distinguishing cellulitis from PTA on a standard clinical examination is difficult. This trial aims to explore whether point-of-care transoral ultrasound can improve diagnostic accuracy and guide successful needle aspiration in patients referred with PTA.METHODS: A randomised, controlled multicentre trial will be conducted at the departments of otorhinolaryngology, head and neck surgery at Rigshospitalet and Odense University Hospital. Patients referred with PTA will be randomised to either standard clinical examination (control) or standard clinical examination with supplemental transoral ultrasound (intervention). The diagnostic accuracy, the total number of performed needle aspirations and the proportion of successful needle aspirations will be compared between the two groups. The difference will be evaluated using binary logistic regression and a generalised estimating equation to adjust for clustering of data within each physician and each hospital. A total of 88 patients are necessary to measure the clinical effect of adding transoral ultrasound.CONCLUSIONS: This study will explore the clinical benefits of adding transoral ultrasound to the diagnostic work-up of patients with peritonsillar infections.FUNDING: The Rigshospitalet and Odense University Hospital Foundation.TRIAL REGISTRATION: Clinicaltrials NCT03824288.

KW - Biopsy, Needle

KW - Cellulitis/diagnostic imaging

KW - Denmark

KW - Double-Blind Method

KW - Drainage/methods

KW - Humans

KW - Logistic Models

KW - Mouth/diagnostic imaging

KW - Multicenter Studies as Topic

KW - Peritonsillar Abscess/diagnostic imaging

KW - Randomized Controlled Trials as Topic

KW - Standard of Care

KW - Ultrasonography

M3 - Journal article

C2 - 31686648

VL - 66

JO - Danish Medical Journal

JF - Danish Medical Journal

SN - 2245-1919

IS - 11

M1 - A5573

ER -