Repairing Peri-Anal Fistulas with regenerative cell therapeutics (REP-PAF)

Odense University Hospital0 个研究点目标入组 75 人开始时间: 2023年11月18日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

发起方