Permacol Paste in Perianal Crohn's Disease

Crohn Disease Clinical Trial

— UPpCro  

Official title:

Use of Permacol Paste in Perianal Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776825
• Other study ID #: 2134
• Status: Recruiting
• Start date: February 7, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: February 2021
• Source: Istituto Clinico Humanitas
• Contact: Francesca Di Candido, MD
• Phone: +390282247776
• Email: francesca.di_candido[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.

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 patients prospectively indicated to Permacol Paste treatment during one year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Crohn Disease
• Fistula
• Perianal Fistula

Intervention

Device:
• Permacol Paste
Permacol Paste Injection

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Medtronic

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perianal fistula closure rate	Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure	12 months
Secondary	Patients quality of life	Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life (IBDQ). IBDQ is a disease-specific questionnaire included 32 questions. The questions consisted of 4 domains as follows: Bowel symptoms (10 questions), systemic symptoms (5 questions), emotional functioning (12 questions), and social functioning (5 questions). Every question score ranged from 1 to 7 which 7 corresponded to the highest level of functioning. Total score ranged from 32 to 224. Higher score showed higher quality of life.	12 months
Secondary	Patients continence	Continence will be assessed by means of the Cleveland Clinic Incontinence Score (CCIS, or Wexner scale). This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).	12 months