Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of … (NCT05594862) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
Italy80 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.