Crypto-glandular perianal fistula
Conditions
Brief summary
The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
Detailed description
Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively, The risk factors for recurrence of PAF, The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging., A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy.
Interventions
DRUGMetronidazole Tablets 500 mg
DRUGAdipose Derived Regenerative Cells ADRC/SVF
DRUGADRC001
DRUGZinnat 500 mg film-coated tablets
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively, The risk factors for recurrence of PAF, The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging., A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy. | — |
Countries
Denmark
Outcome results
None listed