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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The landmark technique | Active Comparator | 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. |
|
| Ultrasound-guided aspiration | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoral ultrasound | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
Clinical findings of peritonsillar abscess by one of the following:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Todsen, MD, PhD | Contact | 51847468 | tobias.todsen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | Copenhagen East | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31686648 | Derived | 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. |
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| ID | Term |
|---|---|
| D000039 | Peritonsillar Abscess |
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| The landmark technique | Procedure | A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted. |
|
| Number of visits in outpatient clinic | Until full recovery from peritonsilar infection |
| Patient-reported outcome | 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). | From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months. |
| Odense University Hospital | Recruiting | Odense | Odense C | 5000 | Denmark |
|
| D000038 |
| Abscess |
| D013492 | Suppuration |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |