Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Umeå
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
perianal abscess that needs surgical treatment, over the age of 18
Disqualifiers
Under the age of 18 or unable to understand study information because of language difficulties or dementia.
Trial design
Design model
Parallel
Treatments tested in this trial
Perianal abscess drainage
Procedure/SurgeryThe 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
DeviceThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ultrasonography, abscessExperimental treatment 2 interventions
Group B: Control group with clincial inscisionOther 1 intervention
Trial outcomes
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.
Time frame
up to one yearSponsors and contacts
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Source ClinicalTrials.gov