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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KULIST | Experimental | Medical Device, Activated carbon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KULIST | Device | Twice daily dosing for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of fistula healing, change from baseline | Fistula assessed as healed/not healed | week 8 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Anal ultrasonography, change from baseline | Healed/not healed | week 8 and 24 |
| Patient assessment of Symptoms and Impact on Daily Function, change from baseline | By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Måns Bohe, MD, PhD | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malmö University Hospital Dept of Surgery | Malmö | Malmö | 205 02 | Sweden | ||
| Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB |
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| week 8 and 24 |
| Safety, change from baseline | Standard collection of adverse events and adverse device effects. | week 2, 8, 24 |
| Stockholm |
| Stockholm County |
| 182 88 |
| Sweden |