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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-07

Study Completion Date

2025-03-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Rectovaginal Fistula Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Microfractured adipose tissue injection and plug placement

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

Group Type EXPERIMENTAL

Microfractured adipose tissue injection and plug placement

Intervention Type DEVICE

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

endoanal mucosa flap

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.

Group Type ACTIVE_COMPARATOR

Microfractured adipose tissue injection and plug placement

Intervention Type DEVICE

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

Interventions

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Microfractured 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

Intervention Type DEVICE

Other Intervention Names

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Lipogems LGD 60 CND V0599 - RDM 1256088 Surgimend AWR 3X3 cm, 606-001-012 DM 409689/R

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No