NCT02306382

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Dec 2012Dec 2028

Study Start

First participant enrolled

December 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

13 years

First QC Date

December 13, 2012

Last Update Submit

November 28, 2023

Conditions

Perianal AbscessAnal FistulasIncontinence

Keywords

endoanal ultrasonographydrainageperianal abscessfistulasincontience

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ultrasonography, abscess

EXPERIMENTAL

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

Procedure: Perianal abscess drainageDevice: 3D ultrasonography

Control group with clincial inscision

OTHER

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

Interventions

Perianal abscess drainagePROCEDURE

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.

Also known as: 1
Control group with clincial inscisionultrasonography, abscess
3D ultrasonographyDEVICE

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.

Also known as: 2
ultrasonography, abscess

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • perianal abscess that needs surgical treatment, over the age of 18

You may not qualify if:

  • Under the age of 18 or unable to understand study information because of language difficulties or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Umeå, County of Vasterbotten §, 901 85, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal FistulaFistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Karin Gustafsson, MD

    University Hospital, Umeå

    PRINCIPAL INVESTIGATOR

  • Karin Strigård Strigård, MD

    University Hospital, Umeå

    STUDY DIRECTOR

  • Ulf Gunnarsson, MD

    University Hospital, Umeå

    STUDY CHAIR

Central Study Contacts

Karin Strigård, MD

CONTACT

+46 785 5000karin.strigard@surgery.umu.se

Ulf Gunnarsson, MD

CONTACT

+46 8 5177 0000ulf.gunnarsson@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 3, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2028

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

SE(1)