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Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

NCT ID: NCT02306382

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2028-12-31

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.

Conditions

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Perianal Abscess Anal Fistulas Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasonography, abscess

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

Group Type EXPERIMENTAL

Perianal abscess drainage

Intervention Type PROCEDURE

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.

3D ultrasonography

Intervention Type DEVICE

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.

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.

Group Type OTHER

Perianal abscess drainage

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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1 2

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Umeå

OTHER

Sponsor Role lead

Responsible Party

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Karin Gustafsson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karin Gustafsson, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Umeå

Karin Strigård Strigård, MD

Role: STUDY_DIRECTOR

University Hospital, Umeå

Ulf Gunnarsson, MD

Role: STUDY_CHAIR

University Hospital, Umeå

Locations

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Department of Surgery

Umeå, County of Vasterbotten §, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Karin Strigård, MD

Role: CONTACT

[email protected]
+46 785 5000

Ulf Gunnarsson, MD

Role: CONTACT

[email protected]
+46 8 5177 0000

Facility Contacts

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Karin Gustafsson, MD

Role: primary

[email protected]
+46 70 3364755

Other Identifiers

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1-Gustafsson

Identifier Type: -

Identifier Source: org_study_id