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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
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, Italy
Start Date
January 7, 2023
Primary Completion Date
March 30, 2024
Completion Date
March 30, 2025
Last Updated
February 7, 2025
3
ACTUAL participants
Microfractured adipose tissue injection and plug placement
DEVICE
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT07245394
NCT07089420
Data Source & Attribution
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