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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perianal Crohn's Disease | Permacol Paste injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permacol Paste | Device | Permacol Paste Injection |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Perianal Crohn's Disease Patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Di Candido, MD | Contact | +390282247776 | francesca.di_candido@humanitas.it | |
| Annalisa Maroli, PhD | Contact | +390282247776 | annalisa.maroli@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Recruiting | Rozzano | MI | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39473704 | Derived | La Raja C, Maroli A, Foppa C, Gabbiadini R, Dal Buono A, Armuzzi A, Carvello M, Spinelli A. Collagen Paste Injection in Crohn's Disease Perianal Fistula: Long-term Outcomes of a Pilot, Prospective Cohort Study. J Anus Rectum Colon. 2024 Oct 25;8(4):271-278. doi: 10.23922/jarc.2024-008. eCollection 2024. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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 |
| D007410 | Intestinal Diseases |