Anal Fissure, Perianal Crohn Disease, Perianal Fistula, Perianal Fistula Due to Crohn's Disease, Rectovaginal Fistula
Conditions
Brief summary
Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median & interquartile range (IQR)
Interventions
PROCEDURERegenerative therapy with SVF-PRP to supplement perianal surgery
Regenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to supplement perianal surgery
Sponsors
Kantonsspital Winterthur KSW
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Healing | 1 year | Absence of fistula opening and discharge, well-being |
| MRI healing | 1year | Absence of active fistula and abscess |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal continence | 1 year | Vaizey score |
| Quality of life (general and related to perianal diseases) | 1 year | FIQoL |
| Costs | 1 year | Direct cost to patient, institution, and payee |
Countries
Switzerland
Contacts
Primary ContactMichel Adamina, MD, PD, MSc, EMBA HSG
Backup ContactRebekka Sterki
Outcome results
None listed