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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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenerative therapy with SVF-PRP to supplement perianal surgery | Procedure | Regenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to supplement perianal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Healing | Absence of fistula opening and discharge, well-being | 1 year |
| MRI healing | Absence of active fistula and abscess | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal continence | Vaizey score | 1 year |
| Quality of life (general and related to perianal diseases) | FIQoL | 1 year |
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Inclusion Criteria:
Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease
Exclusion Criteria:
-
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Patient with complex perianal disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Adamina, MD, PD, MSc, EMBA HSG | Contact | +41522663376 | michel.adamina@ksw.ch | |
| Rebekka Sterki | Contact | +41522662040 | rebekka.sterki@ksw.ch |
| Name | Affiliation | Role |
|---|---|---|
| Michel Adamina, MD, PD, MSc, EMBA HSG | Chief of Colorectal Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
Anonymized data could be shared upon reasonable request and pending ethical clearance
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| Costs | Direct cost to patient, institution, and payee | 1 year |
| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D012006 | Rectovaginal Fistula |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012003 | Rectal Fistula |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D014624 | Vaginal Fistula |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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