Crohn Disease, Rectovaginal Fistula
Conditions
Keywords
MICROFTACTURED ADIPOSE TISSUE, BIOLOGIC MESH, ENDOANAL FLAP, LIPOSUCTION
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.
Interventions
DEVICEMicrofractured adipose tissue injection and plug placement
surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Randomization procedures and statistical analyses will be performed by an investigator not involved in the clinical evaluation or surgical treatment of patients. All clinical evaluations will be performed by independent co-investigators not involved in the surgical procedures and blinded to patient assignment. The dedicated radiologist who will evaluate the MRI scans will be blind to patient allocation. Surgeons will not be able to share information about the treatment used in the surgical procedure and will not be able to participate in any clinical evaluation of the MPC during the study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed