Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement

Not Applicable

Suspended

• Conditions: Rectovaginal Fistula; Crohn Disease

• Registration Number: NCT06813768
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial

Detailed Description

The goal of this clinical trial is to compare, the efficacy of

* circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus

* endoanal mucosal flap in terms of clinical and radiological healing (combined remission)

in patients with Crohn's rectovaginal fistulas refractory to standard treatment,

Secondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life.

Study Timeline

• Study Start: 2023-01-07
• Primary Completion: 2024-03-30
• Status Verified: 2024-12
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Confirmed Crohn's disease
• presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)
• The patient has received, understood and signed the informed consent to actively participate in the study.
• The patient is able to understand the conditions of the study and to participate for the whole duration.

Exclusion Criteria

• presence of oostomy
• Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.
• Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.
• Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
• Patients with active oncological or lymphoproliferative diseases
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
combined remission	24 weeks	clinical (absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) and radiological (absence of abscesses \> 3 mm) closure of the fistula

Secondary Outcome Measures

Name	Time	Method
clinical remission	12, 16, 20, 24 weeks	absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) with radiological presence of abscesses \> 3 mm
clinical response	12, 16, 20, 24 weeks	at least 50% reduction in drainage of the treated vaginal orifice that was draining at baseline despite gentle digital compression.
failure	12, 16, 20, 24 weeks	"no change/worsening" of vaginal drainage and patients who, in the judgment of the investigator, require treatment with antibiotics to control recurrent perianal sepsis
IBDQ score (quality of life)	4, 8, 12, 16, 20, 24 weeks	changes of Inflammatory Bowel Disease Questionnaire (IBDQ) scores
Incidence of adverse events	4, 8, 12, 16, 20, 24 weeks	comparison of incidence of adverse events and serious adverse events in the two arms

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, BO, Italy