Permacol Paste in Perianal Crohn's Disease
UPpCro
Use of Permacol Paste in Perianal Crohn's Disease
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedStudy Start
First participant enrolled
February 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 3, 2021
February 1, 2021
2.4 years
June 8, 2018
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Perianal fistula closure rate
Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure
12 months
Secondary Outcomes (2)
Patients quality of life
12 months
Patients continence
12 months
Study Arms (1)
Perianal Crohn's Disease
Permacol Paste injection
Interventions
Eligibility Criteria
Perianal Crohn's Disease Patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Clinico Humanitaslead
- Medtroniccollaborator
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
Related Publications (1)
La Raja C, Maroli A, Foppa C, Gabbiadini R, Dal Buono A, Armuzzi A, Carvello M, Spinelli A. Collagen Paste Injection in Crohn's Disease Perianal Fistula: Long-term Outcomes of a Pilot, Prospective Cohort Study. J Anus Rectum Colon. 2024 Oct 25;8(4):271-278. doi: 10.23922/jarc.2024-008. eCollection 2024.
PMID: 39473704DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonino Spinelli, MD, PhD
Istituto Clinico Humanitas
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2018
First Posted
December 17, 2018
Study Start
February 7, 2019
Primary Completion
July 1, 2021
Study Completion
October 1, 2021
Last Updated
February 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share