Efficacy of additional autologous Platelet Rich Stroma in transanal mucosal advancement flap repair of complex cryptoglandular anal fistulas

one0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
•The subjects sign and date a written, informed consent form.
•Participants aged above 18 years.
•Patients with transsphincteric cryptoglandular perianal fistula with only one internal opening (or a second opening directly adjacent) with the indication to undergo a TAFR. Transsphincteric fistula was defined as either recurrent fistula with a history of prior surgi-cal intervention(s) or high transsphincteric course with or without multiple tracts.

•Presence of pelvic sepsis at the time of study entry or unexpectedly at time of reconstruc-tive surgery.
•Perianal fistula is a rectovaginal fistula.
•Presence of an immune compromised status due to systemic autoimmune disease and/or immunosuppressive therapy within 6 months of study entry.
•History of or newly diagnosed inflammatory bowel disease during study period.
•Presence of haematological and coagulation disorder(s) (trombopathy, thrombophilia, thrombocytopenia, leukaemia).
•Any oncological event in the patient’s history in the previous five years.
•Diagnosis of HIV infection with inadequate CD4+ count and high viral load.
•Pregnant and/or breastfeeding women.
•Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.

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