Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perianal abscess drainage, 3D ultrasonography.
- Who it may be relevant to
- Registry conditions: Perianal Abscess, Anal Fistulas, Incontinence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.
Overview
Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence. Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal. The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.
Detailed description
The individual patient is informed about the condition and if meets criteria is offered to take part in the study. Written information and informed consent always noted. Questions about the patients general medical condition is noted and if the person has had problems with perianal abscesses before.
Interventions
- Procedure Perianal abscess drainage
The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained. - Device 3D ultrasonography
The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained.
Primary outcome measures
- adverse events [Time frame: up to one year]
Eligibility criteria
Inclusion criteria
- perianal abscess that needs surgical treatment, over the age of 18
Exclusion criteria
- Under the age of 18 or unable to understand study information because of language difficulties or dementia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Department of Surgery — Umeå
Identifiers
NCT: NCT02306382 · 1-Gustafsson