An interventional study of Perianal abscess drainage and 3D ultrasonography in Perianal Abscess, Anal Fistulas and Incontinence, sponsored by University Hospital, Umeå. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University Hospital, Umeå · Not applicable, Interventional, and Treatment
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.
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.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 200 is above the median of 66 across 115 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →University Hospital, Umeå is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The experimental group will be treated after examination with 3D ultrasonography. Follow up after two months and one year.
Procedure: Perianal abscess drainage · Device: 3D ultrasonography
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
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
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
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 year
The record gives a start of Dec 2012, a primary completion of Dec 2025 and a completion of Dec 2028. It does not say whether these dates are actual or estimated.
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University Hospital, Umeå