Actively Recruiting
Tissue Therapy of Transsphincteric Anal Fistula
Led by University of Southern Denmark · Updated on 2024-11-05
75
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
CONDITIONS
Official Title
Tissue Therapy of Transsphincteric Anal Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) with complex anal fistula (high transsphincteric or suprasphincteric) involving more than 30% of the anal sphincter
- Referred to the surgical department at Odense University Hospital for treatment
- Able to communicate in Danish
- Able to provide informed consent
- Living in the region of southern Denmark during the study
You will not qualify if you...
- Signs of infection or cavities around the fistula
- Simple or low anal fistula treatable by simple surgery
- Ano-vaginal or recto-vaginal fistula
- More than one fistula tract, more than two external openings, or more than one internal opening
- Inflammatory Bowel Disease
- Immunosuppression due to illness or treatment
- Cancer diagnosed within the last 5 years
- Previous radiation therapy to the abdomen or pelvis
- Body mass index under 18.5
- Allergy to penicillin or streptomycin antibiotics
- Blood clotting disorders
- Pregnancy or breastfeeding (positive pregnancy test)
- Confirmed syphilis, HIV, or hepatitis on screening tests
AI-Screening
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Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
K
Karam M Sørensen, Ph.D
CONTACT
T
Tina D Hansen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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