Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas

Erasmus Medical Center21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectovaginal Fistula Anovaginal Fistula

Interventions

autologous platelet-rich stromaPROCEDURE

Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ijsselland Hospital

Capelle aan den IJssel, South Holland, Netherlands

Outcomes

Primary Outcomes

Number of patietns with feasible PRS injection

Feasibility was assessed by the ability to successfully obtain SVF and PRP and to inject the combined product (i.e. PRS) during the procedure.

Time frame: 1 day (day of surgery)

Secondary Outcomes

Number of patients with safe PRS injection

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.

Time frame: 30 days postoperatively

Number of patients with clinical closure

closure of the vaginal fistula opening without complaints of discharge at physical examination

Time frame: 12 months

Number of re-interventions

) the need for unplanned re-interventions due to residual clinical and/or radiological fistulizing disease or recurrent disease

Time frame: 12 months

Number of patients with radiological healing

radiological healing or radiological improvement, based on available MRI reports

Time frame: 12 months

Number of patients with recurrence

the reopening of the vaginal fistula opening after clinical closure and/or radiological healing

Time frame: 12 months

Data from ClinicalTrials.gov

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