Status:
COMPLETED
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
Lead Sponsor:
Nordic Drugs AB
Conditions:
Perianal Fistulas
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 eval...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01462747
Start Date
December 1 2011
End Date
January 1 2013
Last Update
February 13 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Malmö University Hospital Dept of Surgery
Malmo, Malmö, Sweden, 205 02
2
Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
Stockholm, Stockholm County, Sweden, 182 88