Actively Recruiting
Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Led by University Hospital, Umeå · Updated on 2023-11-29
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the diagnosis and treatment of perianal abscesses, comparing traditional surgical drainage with a newer method using 3D ultrasonography. The goal is to evaluate whether ultrasound-guided drainage can reduce complications like abscess recurrence, chronic fistulas, and anal sphincter damage that may cause incontinence. This multicenter randomized study is sponsored by University Hospital, Umeå, and aims to improve healing outcomes. Participants will be randomly assigned to one of two groups: one will receive abscess drainage guided by 3D ultrasonography, and the other will have traditional drainage without ultrasound in the operating room. Both groups will be treated under surgical conditions, and the study includes follow-up visits at two months and one year after treatment to monitor progress and outcomes. During the study, participants will be informed about their condition and screened for eligibility. Researchers will collect medical history and monitor adverse events for up to one year. Follow-up assessments will evaluate healing and complications such as fistula formation or incontinence. The study helps understand how ultrasound may improve treatment and reduce complications in patients with perianal abscesses.
CONDITIONS
Brief Title
Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Perianal abscess that needs surgical treatment
- Age 18 years or older
You will not qualify if you...
- Under the age of 18
- Unable to understand study information due to language difficulties
- Dementia or cognitive impairment preventing consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo randomization to either treatment with 3D ultrasonography followed by abscess drainage or abscess drainage without ultrasonography.
1 visit (in-person)
Duration - Up to 1 year
Participants have follow-up visits to monitor recovery and any adverse events after treatment.
2 visits (at 2 months and 1 year post-treatment)
Trial Site Locations
Total: 1 location
1
Department of Surgery
Umeå, County of Vasterbotten §, Sweden, 901 85
Actively Recruiting
Research Team
K
Karin Strigård, MD
U
Ulf Gunnarsson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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