Efficacy and Safety of Treatment of Complex Idiopathic Fistula-in-Ano Using Autologous Centrifuged Adipose Tissue Containing Progenitor Cells: A Randomized Controlled Trial
التفاصيل البيبلوغرافية
العنوان:
Efficacy and Safety of Treatment of Complex Idiopathic Fistula-in-Ano Using Autologous Centrifuged Adipose Tissue Containing Progenitor Cells: A Randomized Controlled Trial
BACKGROUND Mesenchymal stem cells derived from adipose tissue have been successfully used to promote sphincter-saving anal fistula healing. OBJECTIVE The aim of this study was to evaluate the efficacy and safety of the use of autologous centrifuged adipose tissue in the healing process of cryptoglandular complex anal fistulas. DESIGN This is a randomized controlled trial. SETTINGS This study was conducted at a single center. PATIENTS Patients with complex perianal fistulas not associated with Crohn's disease were included. Rectovaginal fistulas were not included. INTERVENTIONS Patients were randomly allocated to receive treatment with centrifuged adipose tissue injection (experimental group) and without injection (control group) in combination with fistula surgery. MAIN OUTCOME MEASURES The primary outcome was defined as the proportion of patients with complete fistula closure at 4 weeks (short-term outcome) and 6 months after surgery (long-term outcome). Healing was defined as when the external opening was closed with no perianal discharge on clinical assessment. The secondary outcome was safety that was evaluated by the analysis of adverse events up to 3 months after surgery. Pelvic MRI was performed at 3 months to assure safety and the accuracy of the clinical determination of healing. Postoperative pain, return to work/daily activities, persistent closure at 6 months, fecal incontinence, and patient satisfaction were evaluated. RESULTS Fifty-eight patients who received centrifuged adipose tissue injection and 58 patients who did not receive centrifuged adipose tissue injection were included in the safety and efficacy analysis. After 4 weeks, the healing rate was 63.8% in the experimental group compared with 15.5% in the control group (p < 0.001). No major adverse events were recorded. Postoperative anal pain was significantly lower in the injection group. Time taken to return to work/daily activities was significantly shorter in the experimental group (3 days) than in the control group (17 days). At 6 months, persistent closure was similar in the 2 groups (86.2% vs 81%). Fecal Incontinence Score at 6 months after surgery was identical to the preoperative score. Patient satisfaction was high in both groups. LIMITATIONS The absence of blinding, the lack of correlation between stem cell content, and the clinical outcome were limitations of the study. CONCLUSIONS Autologous centrifuged adipose tissue injection may represent a safe, efficacious, and inexpensive option for the treatment of complex fistula-in-ano. See Video Abstract at http://links.lww.com/DCR/B607. CLINICAL TRIALS REGISTRATION URL: https://www.clinicaltrials.gov. Identifier: NCT04326907. EFICACIA Y SEGURIDAD DEL TRATAMIENTO DE LA FSTULA ANAL COMPLEJA IDIOPTICA UTILIZANDO TEJIDO ADIPOSO CENTRIFUGADO AUTLOGO QUE CONTIENE CLULAS PROGENITORAS UN ENSAYO CONTROLADO ALEATORIO ANTECEDENTES:Las celulas madre mesenquimales derivadas del tejido adiposo se han utilizado con exito para promover la curacion de la fistula anal con preservacion de esfinter.OBJETIVO:El objetivo de este estudio fue evaluar la eficacia y seguridad del uso de tejido adiposo autologo centrifugado en el proceso de cicatrizacion de fistulas anales complejas de origen criptoglandular.DISENO:Ensayo controlado aleatorio.ENTORNO CLINICO:Estudio unicentrico.PACIENTES:Se incluyeron pacientes con fistulas perianales complejas no asociadas a Enfermedad de Crohn. No se incluyeron las fistulas rectovaginales.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente para recibir tratamiento con inyeccion de tejido adiposo centrifugado (grupo experimental) y sin inyeccion (grupo de control) en combinacion con cirugia de fistula.PRINCIPALES MEDIDAS DE VALORACION:El resultado primario se definio como la proporcion de pacientes con cierre completo de la fistula a las 4 semanas (resultado a corto plazo) y 6 meses despues de la cirugia (resultado a largo plazo). La curacion se definio cuando orificio externo se cerro sin secrecion perianal en la valoracion clinica. El resultado secundario fue la seguridad que se evaluo mediante el analisis de los eventos adversos (EA) hasta 3 meses despues de la cirugia. La resonancia magnetica pelvica se realizo a los 3 meses para garantizar la seguridad y la precision clinica de la curacion. Se evaluo el dolor postoperatorio, el regreso al trabajo / actividades diarias, el cierre persistente a los 6 meses, la incontinencia fecal y la satisfaccion del paciente.RESULTADOS:Cincuenta y ocho pacientes que recibieron inyeccion de tejido adiposo centrifugado y 58 pacientes que no recibieron inyeccion de tejido adiposo centrifugado se incluyeron en el analisis de seguridad y eficacia. Despues de 4 semanas, la tasa de curacion fue del 63,8% en el grupo experimental en comparacion con el 15,5% en el grupo de control (p