Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Not Applicable

Recruiting

• Conditions: Perianal Abscess; Anal Fistulas; Incontinence
• Interventions: Procedure: Perianal abscess drainage; Device: 3D ultrasonography

• Registration Number: NCT02306382
• Lead Sponsor: University Hospital, Umeå

Brief Summary

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasonography, abscess	3D ultrasonography	The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.
ultrasonography, abscess	Perianal abscess drainage	The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.
Control group with clincial inscision	Perianal abscess drainage	The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year.

Primary Outcome Measures

Name	Time	Method
adverse events	up to one year	Patients will be assessed in the outpatient clinic after 2 months and 1 year after surgical treatment. Eventual complications may include anal sepsis, recurrence of anal abscess and fistula formation.

Trial Locations

Locations (1)

Department of Surgery; 🇸🇪 Umea, County Of Vasterbotten §, Sweden