Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Perianal Abscess, Anal Fistulas, Incontinence

Intervention / Treatment
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* Procedure: Perianal abscess drainage
* Device: 3D ultrasonography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasonography, abscess<br>The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year. | Procedure: Perianal abscess drainage<br>* 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.<br>* Other names: 1;Device: 3D ultrasonography<br>* 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.<br>* Other names: 2;|
| Other: Control group with clincial inscision<br>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<br>* 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.<br>* Other names: 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoanal ultrasonography, drainage, perianal abscess, fistulas, incontience