Permacol Paste in Perianal Crohn's Disease

Istituto Clinico Humanitas20 enrolled

Overview

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

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

Conditions

Crohn Disease Perianal Fistula

Interventions

Permacol PasteDEVICE

Permacol Paste Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Clinico Humanitas

Rozzano, MI, Italy

RECRUITING

Outcomes

Primary Outcomes

Perianal fistula closure rate

Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 12 months

Central Contacts

Francesca Di Candido, MD

CONTACT

+390282247776 francesca.di_candido@humanitas.it

Annalisa Maroli, PhD

CONTACT

+390282247776 annalisa.maroli@humanitas.it

Data from ClinicalTrials.gov

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