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OpenTrials
Completed

NCT Number: NCT06798935

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

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.

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Key information

Conditions

Rectovaginal Fistula Anovaginal Fistula Digestive System Diseases Digestive System Fistula Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Urogenital Diseases Vaginal Diseases Vaginal Fistula

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ijsselland Hospital

Capelle aan den IJssel, South Holland, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous platelet-rich stroma

Procedure

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

Primary outcomes

  1. Number of patietns with feasible PRS injection

    Time frame: 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 outcomes

  1. Number of patients with safe PRS injection

    Time frame: 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.

  2. Number of patients with clinical closure

    Time frame: 12 months

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

  3. Number of re-interventions

    Time frame: 12 months

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

  4. Number of patients with radiological healing

    Time frame: 12 months

    radiological healing or radiological improvement, based on available MRI reports

  5. Number of patients with recurrence

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • IJsselland Hospital

Registry information

Acronym: PRS-RVF

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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