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

IRCCS Azienda Ospedaliero-Universitaria di Bologna3 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rectovaginal Fistula Crohn Disease

Interventions

Microfractured adipose tissue injection and plug placementDEVICE

surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy

Outcomes

Primary Outcomes

combined remission

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

Time frame: 24 weeks

Secondary Outcomes

clinical remission

absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) with radiological presence of abscesses \> 3 mm

Time frame: 12, 16, 20, 24 weeks

clinical response

at least 50% reduction in drainage of the treated vaginal orifice that was draining at baseline despite gentle digital compression.

Time frame: 12, 16, 20, 24 weeks

failure

"no change/worsening" of vaginal drainage and patients who, in the judgment of the investigator, require treatment with antibiotics to control recurrent perianal sepsis

Time frame: 12, 16, 20, 24 weeks

IBDQ score (quality of life)

changes of Inflammatory Bowel Disease Questionnaire (IBDQ) scores

Time frame: 4, 8, 12, 16, 20, 24 weeks

Incidence of adverse events

comparison of incidence of adverse events and serious adverse events in the two arms

Time frame: 4, 8, 12, 16, 20, 24 weeks

Data from ClinicalTrials.gov

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