Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas

Nordic Drugs AB28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perianal Fistulas

Interventions

KULISTDEVICE

Twice daily dosing for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Malmö University Hospital Dept of Surgery

Malmö, Malmö, Sweden

Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Clinical evaluation of fistula healing, change from baseline

Fistula assessed as healed/not healed

Time frame: week 8 and 24

Secondary Outcomes

Anal ultrasonography, change from baseline

Healed/not healed

Time frame: 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

Time frame: week 8 and 24

Safety, change from baseline

Standard collection of adverse events and adverse device effects.

Time frame: week 2, 8, 24

Data from ClinicalTrials.gov

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