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The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
Full description
Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.
Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
Superficial fistula involving a part of the external sphincter muscle
Age: ≥18 years and ≤ 75 years
Informed consent and/or Letter of Authority (as applicable) obtained
Exclusion Criteria
Inflammatory Bowel Disease (IBD)
Rectovaginal fistulas
Rectourethral fistulas
Rectovesical fistulas
Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
Any surgical treatment for perianal fistulas
Colorectal and/or anal malignancy
Other malignancy requiring active treatment
Subcutaneous fistulas not involving any part of the external sphincter
Other diseases which as per the investigator's opinion should be contraindicated
Subjects who are not able to complete study procedures as per the investigator's opinion
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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