Anovaginal Fistula, Rectovaginal Fistula
Conditions
Keywords
rectovaginal fistula, anovaginal fistula, platelet-rich stroma, stromal vascular fraction, platelet-rich plasma, autologous, cell therapy
Brief summary
Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.
Interventions
PROCEDUREautologous platelet-rich stroma
Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma
Sponsors
IJsselland ziekenhuis
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients presenting with significant symptoms of a rectovaginal fistula (RVF) * RVF confirmed on imaging or with a high suspicion based on imaging findings (magnetic resonance imaging \[MRI\] and/or endoanal ultrasound \[EUS\])
Exclusion criteria
* Patients with active proctitis * Patients with the presence of associated (not properly drained)) pelvic abscess * Patients with immune suppressed status * Patients with hematological disorders * Patients with any oncological event in the five years prior to study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patietns with feasible PRS injection | 1 day (day of surgery) | Feasibility was assessed by the ability to successfully obtain SVF and PRP and to inject the combined product (i.e. PRS) during the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with safe PRS injection | 30 days postoperatively | Safety was assessed by documenting the number of (serious) adverse events related to PRS injection within 30 days postoperatively. In addition, we report on number of serious fistula-related emergency room (ER) visits and number of readmissions within 30 days postoperatively. |
| Number of patients with clinical closure | 12 months | closure of the vaginal fistula opening without complaints of discharge at physical examination |
| Number of re-interventions | 12 months | ) the need for unplanned re-interventions due to residual clinical and/or radiological fistulizing disease or recurrent disease |
| Number of patients with radiological healing | 12 months | radiological healing or radiological improvement, based on available MRI reports |
| Number of patients with recurrence | 12 months | the reopening of the vaginal fistula opening after clinical closure and/or radiological healing |
Countries
Netherlands
Outcome results
None listed