Perianal Fistulas
Conditions
Brief summary
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
Detailed 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.
Interventions
DEVICEKULIST
Twice daily dosing for 8 weeks
Sponsors
Nordic Drugs AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with perianal fistulas diagnosed by clinical examination and evaluated as not healed/open 2. Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976) 3. Superficial fistula involving a part of the external sphincter muscle 4. Age: ≥18 years and ≤ 75 years 5. Informed consent and/or Letter of Authority (as applicable) obtained
Exclusion criteria
6. Inflammatory Bowel Disease (IBD) 7. Rectovaginal fistulas 8. Rectourethral fistulas 9. Rectovesical fistulas 10. Extra-sphincteric and supra-sphincteric fistula according to Parks´classification 11. Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator. 12. Any surgical treatment for perianal fistulas 13. Colorectal and/or anal malignancy 14. Other malignancy requiring active treatment 15. Subcutaneous fistulas not involving any part of the external sphincter 16. Other diseases which as per the investigator's opinion should be contraindicated 17. Subjects who are not able to complete study procedures as per the investigator's opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation of fistula healing, change from baseline | week 8 and 24 | Fistula assessed as healed/not healed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anal ultrasonography, change from baseline | week 8 and 24 | Healed/not healed |
| Patient assessment of Symptoms and Impact on Daily Function, change from baseline | week 8 and 24 | By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed |
| Safety, change from baseline | week 2, 8, 24 | Standard collection of adverse events and adverse device effects. |
Countries
Sweden
Outcome results
None listed