Status:
UNKNOWN
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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®...
Detailed Description
Treatment of anal fistula pursues permanent healing and preservation of anal continence, not always easy goals in complex anal fistulas. In patients with Crohn's disease, simple surgery (ligation of ...
Eligibility Criteria
Inclusion
- 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
- Active septic process.
- Patients unable to follow the pathway required by the protocol.
- Pregnant women.
- Failure to sign the informed consent form
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04750499
Start Date
September 1 2020
End Date
September 1 2024
Last Update
February 28 2024
Active Locations (1)
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1
Hospital Clínic
Barcelona, Spain, 08006