Phase
Condition
Rectal Disorders
Treatment
ADRC001 injection
ADRC injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criterion:
Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:
able to communicate with Danish language
able to provide informed consent
having address in the region of southern Denmark during the study
Exclusion
Exclusion criteria:
Signs of suppuration/cavitation around the fistula
Simple or low anal fistula, which can be treated by simple surgical incision
Ano-vaginal and recto-vaginal fistula
The presence of more than one fistula tract, more than two external orifices or morethan one internal orifice
Inflammatory Bowel Disease
Immunosuppression (due to clinical condition or medical therapy)
Malignancy within 5 years
Previous radiotherapy of the abdomen and pelvis
BMI under 18.5
Allergy against the antibiotics: Penicillin and streptomycin.
Coagulopathy
Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
Verified syphilis, HIV, or hepatitis on screening test
Study Design
Study Description
Connect with a study center
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
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