Status:
UNKNOWN
Permacol Paste in Perianal Crohn's Disease
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Medtronic
Conditions:
Crohn Disease
Perianal Fistula
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.
Detailed Description
This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patient...
Eligibility Criteria
Inclusion
- Age \> 18, any sex
- Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
- Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
- Non-active or mildly active luminal CD defined by a CDAI \< 220
Exclusion
- CDAI \> 220
- Dominant luminal active CD requiring immediate surgical or medical therapy
- Fistula with \> 3 external openings and \> 2 internal openings
- Severe active proctitis and/or rectal stenosis
- Abscess or pelvic collection \> 2 cm diameter
- Concomitant rectovaginal fistulas
- Concomitant steroid treatment or treated with steroids in the last 4 weeks
Key Trial Info
Start Date :
February 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03776825
Start Date
February 7 2019
End Date
October 1 2021
Last Update
February 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089