Permacol Paste in Perianal Crohn's Disease (UPpCro)

Use of Permacol Paste in Perianal Crohn's Disease

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

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Perianal Fistula
• Intervention / Treatment: Device: Permacol Paste

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 patients prospectively indicated to Permacol Paste treatment during one year.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: +390282247776; Email: annalisa.maroli@humanitas.it
• Study Contact Backup: Name: Francesca Di Candido, MD; Phone Number: +390282247776; Email: francesca.di_candido@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
      • Contact: Annalisa Maroli, PhD; Phone Number: +390282247776; Email: annalisa.maroli@humanitas.it
      • Contact: Francesca Di Candido, MD; Phone Number: 0282247776; Email: francesca.di_candido@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Perianal Crohn's Disease Patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perianal Crohn's Disease; Permacol Paste injection	Device: Permacol Paste; Permacol Paste Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perianal fistula closure rate	Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Fistula; Crohn Disease
• Other Study ID Numbers: 2134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No