UnknownNot Applicable

Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection

Spain12 participantsStarted 2020-09-01

Plain-language summary

The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients of both genders, aged over 18 years old. * Diagnosis, confirmed by standard methods (magnetic resonance and/or trans-anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open). * Seton placed at least 4-6 weeks previously. * No limitations to a periodic follow-up lasting for a total of 12 months * Informed consent form signed. Exclusion Criteria: * Active septic process. * Patients unable to follow the pathway required by the protocol. * Pregnant women. * Failure to sign the informed consent form

What they're measuring

Healing rate

Timeframe: 1 year

Trial details

NCT IDNCT04750499

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09

Contact for this trial

Salvador Guillaumes, MD PhD

+34 687 795 458 guillaumes@clinic.cat

View on ClinicalTrials.gov More Anal Fistula trials