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Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02306382
Enrollment
200
Registered
2014-12-03
Start date
2012-12-31
Completion date
2028-12-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistulas, Incontinence, Perianal Abscess

Keywords

endoanal ultrasonography, drainage, perianal abscess, fistulas, incontience

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.

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.

Interventions

PROCEDUREPerianal 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.

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.

Sponsors

University Hospital, Umeå
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
adverse eventsup to one yearPatients 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.

Countries

Sweden

Contacts

Primary ContactKarin Strigård, MD
karin.strigard@surgery.umu.se+46 785 5000
Backup ContactUlf Gunnarsson, MD
ulf.gunnarsson@ki.se+46 8 5177 0000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026