Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

University Hospital, Umeå

Status: Enrolling

Conditions: Anal Fistulas; Perianal Abscess; Incontinence

Treatments: Procedure: Perianal abscess drainage; Device: 3D ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02306382

1-Gustafsson

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ultrasonography, abscess

Experimental group

Description:

The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.

Treatment:

Device: 3D ultrasonography

Procedure: Perianal abscess drainage

Control group with clincial inscision

Other group

Description:

The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year.

Treatment:

Procedure: Perianal abscess drainage