Permacol Paste in Perianal Crohn's Disease

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

Detailed Description
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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.

Official Title
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Use of Permacol Paste in Perianal Crohn's Disease

Conditions
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Crohn Disease, Perianal Fistula

Intervention / Treatment
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* Device: Permacol Paste


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perianal Crohn's Disease<br>Permacol Paste injection | Device: Permacol Paste<br>* Permacol Paste Injection<br>|

What is the study measuring?
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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 |