The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colon-Proctologia, SIUCP) on the diagnosis and management of hemorrhoidal disease, with the goal of guiding physicians in the choice of the best treatment option. A panel of experts was charged by the Board of the SIUCP to develop key questions on the main topics related to the management of hemorrhoidal disease and to perform an accurate and comprehensive literature search on each topic, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in multiple rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to PICO (patients, intervention, comparison, and outcomes) criteria, and the statements were developed adopting the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology. In cases of grade 1 hemorrhoidal prolapse, outpatient procedures including hemorrhoidal laser procedure and sclerotherapy may be considered the preferred surgical options. For grade 2 prolapse, nonexcisional procedures including outpatient treatments, hemorrhoidal artery ligation and mucopexy, laser hemorrhoidoplasty, the Rafaelo procedure, and stapled hemorrhoidopexy may represent the first-line treatment options, whereas excisional surgery may be considered in selected cases. In cases of grades 3 and 4, stapled hemorrhoidopexy and hemorrhoidectomy may represent the most effective procedures, even if, in the expert panel opinion, stapled hemorrhoidopexy represents the gold-standard treatment for grade 3 hemorrhoidal prolapse.

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 Fístula Anal Compleja Idiopática utilizando Tejido Adiposo Centrifugado Autólogo que contiene Células Progenitoras: un Ensayo Controlado Aleatorio: ANTECEDENTES: Las células madre mesenquimales derivadas del tejido adiposo se han utilizado con éxito para promover la curación de la fístula anal con preservación de esfínter. OBJETIVO: El objetivo de este estudio fue evaluar la eficacia y seguridad del uso de tejido adiposo autólogo centrifugado en el proceso de cicatrización de fístulas anales complejas de origen criptoglandular. DISEÑO: Ensayo controlado aleatorio. ENTORNO CLÍNICO: Estudio unicéntrico. PACIENTES: Se incluyeron pacientes con fístulas perianales complejas no asociadas a Enfermedad de Crohn. No se incluyeron las fístulas rectovaginales. INTERVENCIONES: Los pacientes fueron asignados aleatoriamente para recibir tratamiento con inyección de tejido adiposo centrifugado (grupo experimental) y sin inyección (grupo de control) en combinación con cirugía de fístula. PRINCIPALES MEDIDAS DE VALORACIÓN: El resultado primario se definió como la proporción de pacientes con cierre completo de la fístula a las 4 semanas (resultado a corto plazo) y 6 meses después de la cirugía (resultado a largo plazo). La curación se definió cuando orificio externo se cerró sin secreción perianal en la valoración clínica. El resultado secundario fue la seguridad que se evaluó mediante el análisis de los eventos adversos (EA) hasta 3 meses después de la cirugía. La resonancia magnética pélvica se realizó a los 3 meses para garantizar la seguridad y la precisión clínica de la curación. Se evaluó el dolor postoperatorio, el regreso al trabajo / actividades diarias, el cierre persistente a los 6 meses, la incontinencia fecal y la satisfacción del paciente. RESULTADOS: Cincuenta y ocho pacientes que recibieron inyección de tejido adiposo centrifugado y 58 pacientes que no recibieron inyección de tejido adiposo centrifugado se incluyeron en el análisis de seguridad y eficacia. Después de 4 semanas, la tasa de curación fue del 63,8% en el grupo experimental en comparación con el 15,5% en el grupo de control (p <0,001). No se registraron eventos adversos importantes. El dolor anal posoperatorio fue significativamente menor en el grupo de inyección. El tiempo necesario para volver al trabajo / actividades diarias fue significativamente menor en el grupo experimental (3 días) con respecto al grupo de control (17 días). A los 6 meses, el cierre persistente fue similar en los dos grupos (86,2% vs 81%). La puntuación de incontinencia fecal a los 6 meses después de la cirugía fue idéntica a la puntuación preoperatoria. La satisfacción del paciente fue muy alta en ambos grupos. LIMITACIONES: Ausencia de cegamiento, falta de correlación entre el contenido de células madre y el resultado clínico. CONCLUSIONES: La inyección de tejido adiposo centrifugado autólogo puede representar una opción segura, eficaz y económica para el tratamiento de la fístula anal compleja. Registro de ensayos clínicos: www.clinicaltrials.gov, identificador NCT04326907; No patrocinado. Consulte Video Resumen en http://links.lww.com/DCR/B607.

The enhanced recovery program for perioperative care of the surgical patient reduces postoperative metabolic response and organ dysfunction, accelerating functional recovery. The aim of this study was to determine the impact on postoperative recovery and cost-effectiveness of implementing a colorectal enhanced recovery program in an Italian academic centre. A prospective series of consecutive patients (N = 100) undergoing elective colorectal resection completing a standardized enhanced recovery program in 2013-2015 (ERP group) was compared to patients (N = 100) operated at the same institution in 2010-2011 (Pre-ERP group) before introducing the program. The exclusion criteria were: >80 years old, ASA score of IV, a stage IV TNM, and diagnosis of inflammatory bowel disease. The primary outcome was hospital length of stay which was used as a proxy of functional recovery. Secondary outcomes included: postoperative complications, 30-day readmission and mortality, protocol adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital stay. The ERP group patient satisfaction was also evaluated. Hospital stay was significantly reduced in the ERP versus the Pre-ERP group (4 versus 8 days) as well as nursing workload, with no increase in postoperative complications, 30-day readmission or mortality. ERP group protocol adherence (81%) and patient satisfaction were high. Conventional perioperative protocol was the only independent predictor of prolonged hospital stay. Total mean direct costs per patient were significantly higher in the Pre-ERP versus the ERP group (6796.76 versus 5339.05 euros). Implementing a colorectal enhanced recovery program is feasible, efficient for functional recovery and hospital stay reduction, safe, and cost-effective. High patient satisfaction and nursing workload reduction may also be expected, but high protocol adherence is necessary.