Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Sponsor

University Hospital, Umeå (Other)

Overall Status

Recruiting

CT.gov ID

NCT02306382

Collaborator

(none)

200

Enrollment

Location

Arms

168

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perianal Abscess Anal Fistulas Incontinence	Procedure: Perianal abscess drainage Device: 3D ultrasonography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ultrasonography, abscess The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.	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. Other Names: 1 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. Other Names: 2
Other: Control group with clincial inscision The control group will have drainage of their perianal abscess in the OR without ultrasound. Follow-up after two months and one year.	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. Other Names: 1

Arm

Intervention/Treatment

Experimental: ultrasonography, abscess

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

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.

Other Names:

Device: 3D ultrasonography

Other Names:

Other: Control group with clincial inscision

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

Procedure: Perianal abscess drainage

Other Names:

Outcome Measures

Primary Outcome Measures

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.