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

Phase 2

Completed

• Conditions: Rectovaginal Fistula; Anovaginal Fistula

• Registration Number: NCT06798935
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-11
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04
• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patietns with feasible PRS injection	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 Outcome Measures

Name	Time	Method
Number of patients with safe PRS injection	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.
Number of patients with clinical closure	12 months	closure of the vaginal fistula opening without complaints of discharge at physical examination
Number of re-interventions	12 months	) the need for unplanned re-interventions due to residual clinical and/or radiological fistulizing disease or recurrent disease
Number of patients with radiological healing	12 months	radiological healing or radiological improvement, based on available MRI reports
Number of patients with recurrence	12 months	the reopening of the vaginal fistula opening after clinical closure and/or radiological healing

Trial Locations

Locations (1)

Ijsselland Hospital; 🇳🇱 Capelle aan den IJssel, Zuid-Holland, Netherlands