NCT06798935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

5.7 years

First QC Date

January 18, 2025

Last Update Submit

January 23, 2025

Conditions

Rectovaginal FistulaAnovaginal Fistula

Keywords

rectovaginal fistulaanovaginal fistulaplatelet-rich stromastromal vascular fractionplatelet-rich plasmaautologouscell therapy

Outcome Measures

Primary Outcomes (1)

  • Number of patietns with feasible PRS injection

    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 Outcomes (5)

  • Number of patients with safe PRS injection

    30 days postoperatively

  • Number of patients with clinical closure

    12 months

  • Number of re-interventions

    12 months

  • Number of patients with radiological healing

    12 months

  • Number of patients with recurrence

    12 months

Study Arms (1)

Additional PRS-injection

EXPERIMENTAL

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

Procedure: autologous platelet-rich stroma

Interventions

autologous platelet-rich stromaPROCEDURE

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

Additional PRS-injection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[EUS\])

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ijsselland Hospital

Capelle aan den IJssel, South Holland, Netherlands

Location

Related Publications (3)

  • Deijl W, Arkenbosch J, van Ruler O, van der Woude CJ, Stevens HPJD, de Graaf E, Schouten R. Autologous Platelet-Rich Stroma in Complex Perianal Fistulas. Dis Colon Rectum. 2020 Jun;63(6):860-861. doi: 10.1097/DCR.0000000000001546. No abstract available.

    PMID: 32384409BACKGROUND

  • Schouten WR, Arkenbosch JHC, van der Woude CJ, de Vries AC, Stevens HP, Fuhler GM, Dwarkasing RS, van Ruler O, de Graaf EJR. Efficacy and safety of autologous adipose-derived stromal vascular fraction enriched with platelet-rich plasma in flap repair of transsphincteric cryptoglandular fistulas. Tech Coloproctol. 2021 Dec;25(12):1301-1309. doi: 10.1007/s10151-021-02524-6. Epub 2021 Oct 4.

    PMID: 34606026BACKGROUND

  • Arkenbosch JHC, van Ruler O, Dwarkasing RS, Fuhler GM, Schouten WR, van Oud-Alblas MB, de Graaf EJR, de Vries AC, van der Woude CJ. Stromal vascular fraction with platelet-rich plasma injection during surgery is feasible and safe in treatment-refractory perianal fistulising Crohn's disease: A pilot study. Aliment Pharmacol Ther. 2023 Apr;57(7):783-791. doi: 10.1111/apt.17347. Epub 2022 Dec 26.

    PMID: 36571818BACKGROUND

MeSH Terms

Conditions

Rectovaginal Fistula

Condition Hierarchy (Ancestors)

Rectal FistulaIntestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesVaginal FistulaVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Oddeke van Ruler, GI- surgeon, MD, PhD

    IJsselland Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 29, 2025

Study Start

January 11, 2019

Primary Completion

September 4, 2024

Study Completion

September 4, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)