Repairing Peri-Anal Fistulas with regenerative cell therapeutics (REP-PAF)
- Conditions
- Crypto-glandular perianal fistulaTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-502659-73-01
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
Adult patients (>= 18years) with complex PAF (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, and who are able to communicate with Danish language, and who are having address in the region of southern Denmark during the study
Signs of suppuration/cavitation around the fistula, Allergy against the antibiotics: Penicillin and streptomycin., Coagulopathy, Pregnancy and lactation (positive HCG test), Verified syphilis, HIV, or hepatitis on screening test, 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 more than 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method