ADRC for Cryptoglandular perianal fistula

Inclusion criteria

• {"criterion_text":"- 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\n- and who are able to communicate with Danish language\n- and who are able to communicate with Danish language\n- and who are having address in the region of southern Denmark during the study"}

Exclusion criteria

• {"criterion_text":"- Signs of suppuration/cavitation around the fistula\n- Allergy against the antibiotics: Penicillin and streptomycin.\n- Coagulopathy\n- Pregnancy and lactation (positive HCG test)\n- Verified syphilis, HIV, or hepatitis on screening test\n- Simple or low anal fistula, which can be treated by simple surgical incision\n- Ano-vaginal and recto-vaginal fistula\n- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice\n- Inflammatory Bowel Disease\n- Immunosuppression (due to clinical condition or medical therapy)\n- Malignancy within 5 years\n- Previous radiotherapy of the abdomen and pelvis\n- BMI under 18.5"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation. Measured as healing rate (percentage) at six and twelve months."}

Secondary endpoints

• {"endpoint_text":"- Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively","definition_or_measurement_approach":"Quality of life measured by SF-36 Rand questionnaire; anal continence measured by Wexner Fecal Incontinence score."}
• {"endpoint_text":"- The risk factors for recurrence of PAF","definition_or_measurement_approach":""}
• {"endpoint_text":"- The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.","definition_or_measurement_approach":"Radiological healing defined as no visible fistula or fluid collection >5 mm on MRI."}
• {"endpoint_text":"- A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy.","definition_or_measurement_approach":"Comparison between autologous and allogenic ADRCs for cell characterization, immune responses and efficacy (specific assays not detailed in provided data)."}

Methods

• Patients referred to the surgical department at Odense University Hospital for treatment (must have address in the region of southern Denmark and be able to communicate in Danish).

Denmark

Earliest CTIS Part Ii Submission Date

18-11-2023

Latest Decision Or Authorization Date

22-09-2025

Processing Time Days

674

Number Of Sites

1

Number Of Participants

75

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1, 10, 7, 8, 9","organisation_type":"Hospital/Clinic/Other health care facility"}