Repairing Peri-Anal Fistulas with regenerative cell therapeutics (REP-PAF)
- Conditions
- Crypto-glandular perianal fistula
- Registration Number
- 2022-502659-73-01
- Lead Sponsor
- Odense University Hospital
- Brief Summary
This clinical study aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- 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
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation. The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
- Secondary Outcome Measures
Name Time Method Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively
The risk factors for recurrence of PAF The risk factors for recurrence of PAF
The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging. The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy. A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy.
Trial Locations
- Locations (1)
Odense University Hospital
🇩🇰Odense C, Denmark
Odense University Hospital🇩🇰Odense C, DenmarkKaram SørensenSite contact+4530433553Karam.Faiq.Sorensen@rsyd.dk