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

January 23, 2025 updated by: Anne S. Nieuwstraten, Erasmus Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Capelle aan den IJssel, Zuid-Holland, Netherlands
        • Ijsselland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Additional PRS-injection
Patients suffering from rectovaginal fistula's underwent rectovaginal fistula surgery with an additional injection of autologous PRS
Procedure: autologous platelet-rich stroma
Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day (day of surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days postoperatively
Number of patients with clinical closure
Time Frame: 12 months
closure of the vaginal fistula opening without complaints of discharge at physical examination
12 months
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
12 months
Number of patients with radiological healing
Time Frame: 12 months
radiological healing or radiological improvement, based on available MRI reports
12 months
Number of patients with recurrence
Time Frame: 12 months
the reopening of the vaginal fistula opening after clinical closure and/or radiological healing
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

IJsselland ziekenhuis

Investigators

  • Principal Investigator: Oddeke van Ruler, GI- surgeon, MD, PhD, Ijsselland Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

September 4, 2024

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2019-0038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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