Clinical trial NCT06798935: Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
Official title: Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectovaginal Fistula
Anovaginal Fistula
Keywords: rectovaginal fistula
anovaginal fistula
platelet-rich stroma
stromal vascular fraction
platelet-rich plasma
autologous
cell therapy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: IJsselland ziekenhuis
First posted: 2025-01-29
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patietns with feasible PRS injection
timeFrame: 1 day (day of surgery)
Secondary outcomes:
measure: Number of patients with safe PRS injection
timeFrame: 30 days postoperatively
measure: Number of patients with clinical closure
timeFrame: 12 months
measure: Number of re-interventions
timeFrame: 12 months
measure: Number of patients with radiological healing
timeFrame: 12 months
measure: Number of patients with recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Capelle aan den IJssel
country: Netherlands
facility: Ijsselland Hospital
state: Zuid-Holland
Study officials:
affiliation: IJsselland Hospital
name: Oddeke van Ruler, GI- surgeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.