Peritonsillar AbscessNCT03824288
Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
A study testing Intraoral ultrasound and The landmark technique in people with Peritonsillar Abscess, run by Tobias Todsen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritonsillar Abscess
- What is being tested?
- Intraoral ultrasound and The landmark technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesDenmark
- Study dates
- 26 Nov 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Copenhagen East, 2100
Tobias Todsen, MD, PhD
- Recruiting
Odense University Hospital
Odense, Odense C, 5000
Sanne H Michaelsen, MD
About this study
Official title: A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
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:
Read more
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)
- Conditions
- Peritonsillar Abscess
- Being tested
- Intraoral ultrasound, The landmark technique
- Medical subject headings
- Peritonsillar Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral ultrasoundDiagnostic 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.
The landmark techniqueProcedure or surgery
A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: The landmark technique |
| 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. Receives: Diagnostic Test: Intraoral ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
needle aspirations
total number of needle aspirations performed
Measured: 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
Measured: 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
Measured: 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
Measured: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Number of quincy tonsillectomies
Measured: 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
Measured: 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).
Measured: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start26 Nov 2018
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritonsillar AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tobias Todsen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Tobias Todsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824288
- Sponsor's protocol ID
- VD-2018-361
- Status last verified
- Aug 2019
- First submitted
- 23 Jan 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31686648
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Trial of Ultrasound-Guided Aspiration of Peritonsillar Abscess Versus Conventional Landmark Technique
- ClinicalTrials.gov ID
- NCT03824288
- Acronym / sponsor ID
- VD-2018-361
- Conditions
- Peritonsillar Abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Tobias TodsenUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The landmark technique | Active comparator | Procedure: The landmark techniquePTA 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 | Diagnostic Test: Intraoral ultrasoundAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred to the Department of Otorhinolaryngology suspected for peritonsillar abscess
- Clinical findings of peritonsillar abscess by one of the following:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral ultrasoundThe 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. | Diagnostic test | Ultrasound-guided aspiration |
| The landmark techniqueA 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted. | Procedure or surgery | The landmark technique |
Primary outcome
needle aspirations
Time frame: 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
Time frame: 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
Time frame: 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
4 secondary outcomes
Number of hospitalization days
Time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Number of quincy tonsillectomies
Time frame: 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
Time frame: Until full recovery from peritonsilar infection
Patient-reported outcome
Time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 31686648Todsen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral ultrasound and The landmark technique in people with Peritonsillar Abscess, run by Tobias Todsen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Todsen, MD, PhD (51847468, tobias.todsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
needle aspirations (time frame: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.