Crohn Disease, Perianal Fistula
Conditions
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 patients prospectively indicated to Permacol Paste treatment during one year.
Interventions
DEVICEPermacol Paste
Permacol Paste Injection
Sponsors
Medtronic
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perianal fistula closure rate | 12 months | Complete fistula closure will be defined as absence of spontaneous suppuration or suppuration on applying gentle pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients quality of life | 12 months | 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. |
| Patients continence | 12 months | 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). |
Countries
Italy
Contacts
Primary ContactFrancesca Di Candido, MD
Backup ContactAnnalisa Maroli, PhD
Outcome results
None listed