Crohn Disease
Conditions
Brief summary
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.
Interventions
DEVICELipogems
Micro-fragmented adipose tissue infiltration
Sponsors
Lipogems International spa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient's age is over 18 at the time of surgery. * The patient suffers from Crohn's disease confirmed by instrumental and histological methods. * The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year) * The patient received, understood and signed informed consent for active participation in the study. * The patient is able to understand the conditions of the study and to participate throughout the duration.
Exclusion criteria
* Patients with more than 1 internal and 3 external openings. * Patients with ileus / colo ostomy. * Patients with anus / rectum-vaginal fistulas. * Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis. * Patients with abdominal localization of Crohn's disease who may require general surgery during the study. * Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc). * Patients with clinical conditions that may compromise the success of the surgery or the follow-up. * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Combined remission | 24 weeks | The primary outcome of the study will be the evaluation of the difference between the two experimental groups in terms of "combined remission" which will be defined at 24 weeks from surgery to clinical evaluation as "absence of drainage at a slight digital compression". of all treated external orifices that were draining at baseline and pelvic MRI as the absence of abscesses\> 3 mm in correspondence of the treated perianal fistulas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Clinical remission | 2-4-8-12-24 weeks | Comparison between the two experimental groups in terms of clinical remission at 2 weeks (± 2 days), 4 weeks (± 2 days), 8 weeks (± 2 days), 12 weeks (± 3 days) and 24 weeks ± (5 days) from surgery (ie the closure of all external orifices treated that were draining at baseline despite a slight digital compression) |
Countries
Italy
Outcome results
None listed