Status:
UNKNOWN
Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula
Lead Sponsor:
Hospital Mutua de Terrassa
Conditions:
Anal Fistula
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its t...
Eligibility Criteria
Inclusion
- Patients over 18 years
- Anal fistula with suppuration for more than 6 weeks and less than 1 year, that have not received any previous treatment or at most: curettage and drainage placement
- Complex cryptoglandular anal fistula: medium or high transsphincteric fistula, suprasphincteric fistula and extra sphincter fistula, shown by endoanal ultrasound.
- Low transsphincteric fistulas in patients with fecal incotinence.
- Any cryptoglandular anal fistula with risk factors for anal incontinence: anterior location fistula in women, history of pelvic surgery (hysterectomy, rectal resection), history of pelvic radiotherapy or previous anal surgery
- Draining with Seton placed \>2 weeks before surgery and present at the time of treatment
- Disposition and ability to comply with the study protocol
- Signed informed consent
Exclusion
- Patients diagnosed with inflammatory bowel disease
- Previous history of perianal fistula treated with any surgery different than curettage and seton placement (this include any type of surgery with curative intention, i.e. flap, lift technique, Radiofrequency, laser, stem cells, Filac, etc)
- Presence of Rectovaginal fistula
- Technical impossibility for lipoaspirate (liposuction) technique.
- Presence of perianal collections larger than 2cm
- Presence of several paths from 1 internal hole only
- Presence of secondary fistula paths or tracts
- Perianal surgery necessary at the time of planning the fistula treatment, for reasons other than fistula.
- Major surgery needed within 28 days of recruitment
- Immunomodulator treatment or corticotherapy in a previous period of 6 months
- Stoma patients
- Serious medical or psychiatric illness that requires frequent hospitalization.
- Pregnancy, pregnancy plans or breastfeeding in the next 12 months
- Active smokers, or ex-smokers of less than 3 months
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04790123
Start Date
October 14 2020
End Date
October 1 2024
Last Update
March 2 2023
Active Locations (1)
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1
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221