Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT (NCT03824288) | Clinical Trial Compass
UnknownNot Applicable
Ultrasound-Guided Aspiration of PTA vs Conventional Landmark Technique - a RCT
Denmark88 participantsStarted 2018-11-26
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Trismus
. Unilateral tonsillar/peritonsillar swelling
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing ultrasound-guided needle aspiration to the traditional landmark technique for draining a peritonsillar abscess — how confident are you that one approach is safer or more effective than the other based on what's already known, and would this trial help answer that question for patients like me?
2Since one of the main things this study is tracking is how many needle aspirations are successful on the first try, does that mean there's a real chance the procedure might need to be repeated, and how does that risk compare between the two techniques being studied?
3The trial is also measuring days on sick leave, which tells me recovery time is a factor — based on my specific situation, do you think one method might get me back to normal faster, or is that still genuinely unclear?
4Given that this trial's recruitment status is unknown, is it still actively enrolling patients, and if not, are there other ways I could access ultrasound-guided aspiration or would the standard landmark technique be the recommended path for me right now?
5Is a peritonsillar abscess something that sometimes needs more than just needle aspiration — like surgical drainage or tonsil removal — and how would joining or not joining this trial affect my options if the first approach doesn't work?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
needle aspirations
Timeframe: From date of randomization until the date of full recovery from the treated peritonsilar infection, assessed up to 1 months.
2
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.
3
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.