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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2024-09-04

Brief Summary

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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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Detailed Description

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Conditions

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Rectovaginal Fistula Anovaginal Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Additional PRS-injection

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

Group Type EXPERIMENTAL

autologous platelet-rich stroma

Intervention Type PROCEDURE

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

Interventions

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autologous platelet-rich stroma

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No