Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Incontinence Clinical Trial

Official title:

Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306382
• Other study ID #: 1-Gustafsson
• Status: Recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: University Hospital, Umeå
• Contact: Karin Strigård, MD
• Phone: +46 785 5000
• Email: karin.strigard[@]surgery.umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abscess
• Anal Fistulas
• Fistula
• Incontinence
• Perianal Abscess
• Rectal Fistula

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Surgery	Umea	County Of Vasterbotten §

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	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.	up to one year