CompletedPhase 2

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

Netherlands21 participantsStarted 2019-01-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of patietns with feasible PRS injection

Timeframe: 1 day (day of surgery)

Trial details

NCT IDNCT06798935

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-04

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