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

Erasmus University

Status and phase: Completed; Phase 2

Conditions: Anovaginal Fistula; Rectovaginal Fistula

Treatments: Procedure: autologous platelet-rich stroma

Study type: Interventional

Funder types: Other

Identifiers

NCT06798935

MEC-2019-0038

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Additional PRS-injection

Experimental group

Description:

Patients suffering from rectovaginal fistula's underwent rectovaginal fistula surgery with an additional injection of autologous PRS

Treatment:

Procedure: autologous platelet-rich stroma