Clinical trial NCT06813768: Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement
Official title: Trattamento Delle Fistole Rettovaginali Di Crohn Mediante Combinazine Di Plug in Matrice Di Collagene (SURGIMEND®) Ed Infiltrazione Locale Di Tessuto Adiposo Autologo Microfratturato (LIPOGEMS®)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Rectovaginal Fistula
Crohn Disease
Keywords: MICROFTACTURED ADIPOSE TISSUE
BIOLOGIC MESH
ENDOANAL FLAP
LIPOSUCTION
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: combined remission
timeFrame: 24 weeks
Secondary outcomes:
measure: clinical remission
timeFrame: 12, 16, 20, 24 weeks
measure: clinical response
timeFrame: 12, 16, 20, 24 weeks
measure: failure
timeFrame: 12, 16, 20, 24 weeks
measure: IBDQ score (quality of life)
timeFrame: 4, 8, 12, 16, 20, 24 weeks
measure: Incidence of adverse events
timeFrame: 4, 8, 12, 16, 20, 24 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Silvio Laureti, MD
role: PRINCIPAL_INVESTIGATOR
References: