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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Suspended

Conditions: Crohn Disease; Rectovaginal Fistula

Treatments: Device: Microfractured adipose tissue injection and plug placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06813768

LIPOPLUG - CROHN

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3 participants in 2 patient groups

Microfractured adipose tissue injection and plug placement

Experimental group

Description:

Liposuction (up to 100 cc of adipose tissue) Processing of adipose tissue with lipogems system Drainage of sepsis, courettage of fistula tract Placement of biological prosthesis in the fistula tract, suturing the mesh with interrupted PDS sutures at the internal sphincter Injection of 15 cc of microfractured adipose tissue into the submucosa around the internal orifice and along the fistula tract

Treatment:

Device: Microfractured adipose tissue injection and plug placement

endoanal mucosa flap

Active Comparator group

Description:

A 6-0 absorbable suture will be placed on the skin at the level of the thigh to simulate liposuction Drainage of sepsis, courettage of fistula tract A U-shaped or vertical endoanal mucous flap will be made, after infiltration with 1:100,000 adrenaline of the mucosa surrounding the internal orifice, mobilization of the mucous flap, closure of the internal orifice at the muscular level with 2-0 absorbable stitches of PDS and suture of the mucosal flap with 3-0 absorbable vycril sutures.

Treatment:

Device: Microfractured adipose tissue injection and plug placement