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

Trattamento Delle Fistole Rettovaginali Di Crohn Mediante Combinazine Di Plug in Matrice Di Collagene (SURGIMEND®) Ed Infiltrazione Locale Di Tessuto Adiposo Autologo Microfratturato (LIPOGEMS®)

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

Study Overview

• Status: Suspended
• Conditions: Crohn Disease; Rectovaginal Fistula
• Intervention / Treatment: Device: Microfractured adipose tissue injection and plug placement

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other Names: Lipogems LGD 60 CND V0599 - RDM 1256088; Surgimend AWR 3X3 cm, 606-001-012 DM 409689/R
Active Comparator: 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.	Device: 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; Other Names: Lipogems LGD 60 CND V0599 - RDM 1256088; Surgimend AWR 3X3 cm, 606-001-012 DM 409689/R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical remission	absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) with radiological presence of abscesses > 3 mm	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.	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	12, 16, 20, 24 weeks
IBDQ score (quality of life)	changes of Inflammatory Bowel Disease Questionnaire (IBDQ) scores	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	4, 8, 12, 16, 20, 24 weeks

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Silvio Laureti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: MICROFTACTURED ADIPOSE TISSUE; BIOLOGIC MESH; ENDOANAL FLAP; LIPOSUCTION
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Genital Diseases, Female; Gastroenteritis; Inflammatory Bowel Diseases; Digestive System Fistula; Vaginal Diseases; Intestinal Fistula; Rectal Fistula; Vaginal Fistula; Crohn Disease; Fistula; Rectovaginal Fistula
• Other Study ID Numbers: LIPOPLUG - CROHN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No