Tissue Therapy of Transsphincteric Anal Fistula

Launched by UNIVERSITY OF SOUTHERN DENMARK · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for complex anal fistulas, which are abnormal connections between the anal canal and the skin around the anus. The researchers want to see if a combination of a small surgical procedure and regenerative cellular therapies can help improve the healing of these fistulas. The trial is currently looking for participants who are adults, at least 18 years old, and have a specific type of complex anal fistula that affects a significant portion of their anal muscles. Participants need to be able to communicate in Danish and provide informed consent, and they must live in southern Denmark during the study.

If eligible, participants can expect to receive a treatment that aims to improve their condition while being closely monitored by the medical team. It's important to note that certain individuals will not be able to participate, including those with signs of infection around the fistula, other types of fistulas, or specific health conditions like inflammatory bowel disease or recent cancer treatment. This trial is a great opportunity for those who meet the criteria to potentially benefit from an innovative approach to treating anal fistulas.

Gender

ALL

Eligibility criteria

• 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 criteria:
• • 1. Signs of suppuration/cavitation around the fistula
• • 2. Simple or low anal fistula, which can be treated by simple surgical incision
• • 3. Ano-vaginal and recto-vaginal fistula
• • 4. The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
• • 5. Inflammatory Bowel Disease
• • 6. Immunosuppression (due to clinical condition or medical therapy)
• • 7. Malignancy within 5 years
• • 8. Previous radiotherapy of the abdomen and pelvis
• • 9. BMI under 18.5
• • 10. Allergy against the antibiotics: Penicillin and streptomycin.
• • 11. Coagulopathy
• • 12. Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
• • 13. Verified syphilis, HIV, or hepatitis on screening test