Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study).

BACKGROUND: Perianal fistulas may affect 15-50% of patients with Crohn's disease. Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogenic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European and Spanish Agencies of Medicines and Medical Products as a treatment for fistulas in Crohn's disease. Recent European Crohn's and Colitis Organisation and Spanish Working Group on Crohn's Disease and Ulcerative Colitis guidelines state that darvadstrocel is effective with a favorable safety profile and a strong level of evidence (2). OBJECTIVE: Presenting real-world effectiveness data for darvadstrocel in a Spanish population. DESIGN: Observational retrospective cohort study with prospective data gathering. SETTINGS: Fourteen institutions. PATIENTS: From November 2019-April 2022, all patients (73) treated with darvadstrocel in these institutions were included, fulfilling the following criteria: 1) complex fistula/s in a patient with Crohn's disease; 2) failure of conventional and antitumor necrosis factor treatment; 3) absence of collections >2 cm confirmed by pelvic MRI scan at the time of surgery. INTERVENTIONS: Darvadstrocel treatment. MAIN OUTCOME MEASURES: Clinical response (closure of ≥50% of external openings), complete clinical closure (100% of external openings) and radiological closure (no fluid collection >2 cm, no edema or inflammation) evaluated 6 months after treatment. RESULTS: Clinical response was observed in 63 patients (86.3%), complete clinical closure in 50 patients (68.5%) and radiological closure in 45 patients (69.2%). Combined clinical and radiological response was observed in 41 patients (63.1%). Not all clinically healed patients had radiological closure and vice versa. No serious adverse events were reported. LIMITATIONS: Retrospective. CONCLUSIONS: Study results were consistent with those reported in previous clinical trials, real-world efficacy findings from the INSPIRE study (assessing darvadstrocel effectiveness in Europe, Israel, Switzerland, UK, and Japan) and previously published literature. Darvadstrocel was effective and demonstrated a favorable safety profile when used in normal clinical practice for treatment of fistulas in Crohn's disease. See Video Abstract.

Exactitud diagnóstica en el cáncer de esófago localizado. Estudio observacional retrospectivo.

OBJECTIVE: To assess the accuracy of the diagnostic tests for a correct clinical tumor staging in localized esophageal cancer (EC). METHOD: Retrospective observational study of patients who underwent esophagectomy for cancer in a referral hospital between January 2003 and September 2019. Those patients who received neoadjuvant treatment were excluded in order to avoid bias from downstaging effects. The preoperative stage was compared with the pathological stage of the surgical specimen. Computed tomography (CT) , endoscopic ultrasound (EUS) and positron emission tomography (PET) were evaluated. The pT stage was correlated with the tumor length described in the esophagram (EG). RESULTS: Among the 63 patients included, the clinical staging was correct in 16 (global accuracy 25.4%), it was overstaged in 21 (33.2%) and understaged in 26 (41.3%). For cT staging, the accuracy of EUS was higher than that of CT (46.6% and 34.9%, respectively), specially for early stages. EG tumor length correlated with pT stage (p < 0.05). For cN staging, PET had the highest sensitivity (50.0%) and negative predictive value (75.0%). CONCLUSIONS: Despite the multiple diagnostic tools used, the global accuracy of clinical staging in localized EC is still a challenge. The lack of a test that stands out significantly from the others reinforces the need to use them in a complementary way.

OBJETIVO: Evaluar la exactitud diagnóstica para el estadiaje clínico del cáncer de esófago (CE) localizado. MÉTODO: Estudio observacional retrospectivo de los pacientes esofagectomizados por CE en un hospital de referencia entre enero de 2003 y septiembre de 2019. Se excluyeron aquellos que recibieron neoadyuvancia para evitar sesgos de infraestadiaje. Se comparó el estadio preoperatorio con el estadio patológico de la pieza quirúrgica. Se evaluaron la tomografía computarizada (TC), la ecoendoscopia (EUS) y la tomografía por emisión de positrones (PET). El estadio pT se correlacionó con la longitud tumoral descrita en el esofagograma (EG). RESULTADOS: De los 63 pacientes incluidos, el estadiaje clínico fue correcto en 16 (exactitud 25.4%), con sobreestadiaje en 21 (33.2%) e infraestadiaje en 26 (41.3%). Para el estadiaje cT, la EUS fue superior a la TC (exactitud 46.6% y 34.9%, respectivamente), en especial para estadios precoces. La longitud tumoral del EG se correlacionó con el estadio pT (p < 0.05). Para el estadiaje cN, la PET tuvo la mayor sensibilidad (50.0%) y el mayor valor predictivo negativo (75.0%). CONCLUSIONES: A pesar de las múltiples herramientas diagnósticas empleadas, la exactitud diagnóstica en el CE localizado es limitada. La ausencia de una prueba que destaque de manera significativa refuerza la necesidad de emplearlas de forma complementaria.

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain.

AIM: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. METHOD: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. RESULTS: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. CONCLUSIONS: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden.

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain / Carga asistencial y resultados del tratamiento quirúrgico de la colitis ulcerativa: un análisis retrospectivo de los últimos 20 años en un hospital terciario de España

Aim: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. Method: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. Results: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. Conclusions: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden. (AU)

Objetivo: Analizar la carga quirúrgica asistencial por CU en 20 años, analizando las características de los pacientes, indicaciones quirúrgicas y resultados a corto y largo plazo. Método: Análisis retrospectivo unicéntrico de pacientes intervenidos de enero del 2000 a diciembre del 2020. La carga asistencial, los datos clínicos y los resultados se analizaron según distribución por décadas. Resultados: Ciento veintiocho pacientes, 37% mujeres, con 376 intervenciones quirúrgicas (296 procedimientos intestinales y 80 anorrectales). El seguimiento medio de la cohorte fue de 106±64 meses. El lapso entre el diagnóstico y la primera cirugía fue <5 años en el 53,3%. En la segunda década del estudio hubo menos pacientes operados (73 frente a 48) y un menor número de intervenciones por paciente (2,7 frente a 2,0). La proporción entre cirugía electiva y urgente se revirtió en la segunda década, observándose un aumento de la cirugía laparoscópica (70% vs. 8%) junto con una disminución de la morbilidad postoperatoria mayor (Clavien-Dindo≥IIIa) (20% vs 8.4%). Se realizó una proctocolectomía restauradora a 80 pacientes, con un fracaso al año del 5% pero del 23,7% a largo plazo. Treinta y siete pacientes requirieron cirugía anorrectal, de los cuales 26 (71%) fueron intervenciones seriadas, la mayoría por complicaciones sépticas de los reservorios. Conclusiones: El número de colectomías y de intervenciones por paciente disminuyó en la última década, a la vez que hubo mejorías en la morbilidad y el abordaje quirúrgico. La necesidad de cirugías secuenciales y de una vigilancia instrumental activa a largo plazo por el posible deterioro funcional constituye una importante carga clínica. (AU)

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain / Carga asistencial y resultados del tratamiento quirúrgico de la colitis ulcerativa: un análisis retrospectivo de los últimos 20 años en un hospital terciario de España

Aim: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. Method: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. Results: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. Conclusions: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden. (AU)

Objetivo: Analizar la carga quirúrgica asistencial por CU en 20 años, analizando las características de los pacientes, indicaciones quirúrgicas y resultados a corto y largo plazo. Método: Análisis retrospectivo unicéntrico de pacientes intervenidos de enero del 2000 a diciembre del 2020. La carga asistencial, los datos clínicos y los resultados se analizaron según distribución por décadas. Resultados: Ciento veintiocho pacientes, 37% mujeres, con 376 intervenciones quirúrgicas (296 procedimientos intestinales y 80 anorrectales). El seguimiento medio de la cohorte fue de 106±64 meses. El lapso entre el diagnóstico y la primera cirugía fue <5 años en el 53,3%. En la segunda década del estudio hubo menos pacientes operados (73 frente a 48) y un menor número de intervenciones por paciente (2,7 frente a 2,0). La proporción entre cirugía electiva y urgente se revirtió en la segunda década, observándose un aumento de la cirugía laparoscópica (70% vs. 8%) junto con una disminución de la morbilidad postoperatoria mayor (Clavien-Dindo≥IIIa) (20% vs 8.4%). Se realizó una proctocolectomía restauradora a 80 pacientes, con un fracaso al año del 5% pero del 23,7% a largo plazo. Treinta y siete pacientes requirieron cirugía anorrectal, de los cuales 26 (71%) fueron intervenciones seriadas, la mayoría por complicaciones sépticas de los reservorios. Conclusiones: El número de colectomías y de intervenciones por paciente disminuyó en la última década, a la vez que hubo mejorías en la morbilidad y el abordaje quirúrgico. La necesidad de cirugías secuenciales y de una vigilancia instrumental activa a largo plazo por el posible deterioro funcional constituye una importante carga clínica. (AU)

Prognostic Value of the Circumferential Resection Margin After Curative Surgery for Rectal Cancer: A Multicenter Propensity Score-Matched Analysis.

BACKGROUND: Recently, positive circumferential resection margin has been found to be an indicator of advanced disease with a high risk of distant recurrence rather than local recurrence. OBJECTIVE: The study aimed to analyze the prognostic impact of the circumferential resection margin on long-term oncological outcomes in patients with rectal cancer. DESIGN: This was a multicenter, propensity score-matched (2:1) analysis comparing the positive and negative circumferential resection margins. SETTINGS: The study was conducted at 5 high-volume centers in Spain. PATIENTS: Patients who underwent total mesorectal excision with curative intent for middle-low rectal cancer between 2006 and 2014 were included. MAIN OUTCOME MEASURES: The main outcomes were local recurrence, distant recurrence, overall survival, and disease-free survival. RESULTS: The unmatched initial cohort consisted of 1599 patients, of whom 4.9% had a positive circumferential resection margin. After matching, 234 patients were included (156 with a negative circumferential margin and 78 with a positive circumferential margin). The median follow-up period was 52.5 (22.0-69.5) months. Local recurrence was significantly higher in patients with a positive circumferential margin (33.3% vs 11.5%; p < 0.001). Distant recurrence was similar in both groups (46.2% vs 42.3%; p = 0.651). There were no statistically significant differences in 5-year overall survival (48.6% vs 43.6%; p = 0.14). Disease-free survival was lower in patients with a positive circumferential margin (36.1% vs 52.3%; p = 0.026). LIMITATIONS: This study was limited by its retrospective design. The different neoadjuvant treatment options were not included in the propensity score. CONCLUSIONS: The positive circumferential resection margin was associated with a higher local recurrence rate and worse disease-free survival in comparison with the negative circumferential resection margin. However, the positive circumferential resection margin was not a prognostic indicator of distant recurrence and overall survival. See Video Abstract at http://links.lww.com/DCR/B950 . VALOR PRONSTICO DEL MARGEN DE RESECCIN CIRCUNFERENCIAL DESPUS DE LA CIRUGA CURATIVA PARA EL CNCER DE RECTO UN ANLISIS MULTICNTRICO EMPAREJADO POR PUNTAJE DE PROPENSIN: ANTECEDENTES:En los últimos años, se ha encontrado que el margen de resección circunferencial positivo es un indicador de enfermedad avanzada con alto riesgo de recurrencia a distancia más que de recurrencia local.OBJETIVO:El objetivo fue analizar el impacto pronóstico del margen de resección circunferencial sobre la recidiva local, a distancia y las tasas de supervivencia en pacientes con cáncer de recto.DISEÑO:Este fue un análisis multicéntrico emparejado por puntaje de propensión 2: 1 que comparó el margen de resección circunferencial positivo y negativo.AJUSTES:El estudio se realizó en 5 centros Españoles de alto volumen.PACIENTES:Se incluyeron pacientes sometidos a escisión total de mesorrecto con intención curativa por cáncer de recto medio-bajo entre 2006-2014. Las características clínicas e histológicas se utilizaron para el emparejamiento.PRINCIPALES MEDIDAS DE RESULTADO:Los resultadoes principales fueron la recurrencia local, la recurrencia a distancia, la supervivencia global y libre de enfermedad.RESULTADOS:La cohorte inicial no emparejada consistió en 1599 pacientes; El 4,9% tuvo un margen de resección circunferencial positivo. Tras el emparejamiento se incluyeron 234 pacientes (156 con margen circunferencial negativo y 78 con margen circunferencial positivo). La mediana del período de seguimiento fue de 52,5 meses (22,0-69,5). La recurrencia local fue significativamente mayor en pacientes con margen circunferencial positivo, 33,3% vs 11,5% [HR 3,2; IC 95%: 1,83-5,43; p < 0,001]. La recidiva a distancia fue similar en ambos grupos (46,2 % frente a 42,3 %) [HR 1,09, IC 95 %: 0,78-1,90; p = 0,651]. No hubo diferencias significativas en la supervivencia global a 5 años (48,6 % frente a 43,6 %) [HR 1,09, IC 95 %: 0,92-1,78; p = 0,14]; La supervivencia libre de enfermedad fue menor en pacientes con margen circunferencial positivo, 36,1% vs 52,3% [HR 1,5; IC 95%: 1,05-2,06; p = 0,026].LIMITACIONES:Este estudio estuvo limitado por el diseño retrospectivo. Las diferentes opciones de tratamientos neoadyuvantes no se han incluido en la puntuación de propensión.CONCLUSIONES:El margen de resección circunferencial positivo se asocia con una mayor tasa de recurrencia local y peor supervivencia libre de enfermedad en comparación con el margen de resección circunferencial negativo. Sin embargo, el margen de resección circunferencial positivo no fue un indicador pronóstico de recidiva a distancia ni de supervivencia global. Consulte el Video del Resumen en http://links.lww.com/DCR/B950 . (Traducción- Dr. Yesenia Rojas-Khalil ).

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain.

AIM: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. METHOD: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. RESULTS: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. CONCLUSIONS: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden.

Diagnóstico inesperado en paciente con sospecha de GIST: infiltración gástrica por mieloma múltiple.

El mieloma múltiple se caracteriza por la proliferación neoplásica medular de células plasmáticas productoras de inmunoglobulina monoclonal. Un porcentaje pequeño de pacientes presenta compromiso extramedular en forma de plasmocitoma, siendo la localización más habitual las vías respiratorias altas. La afectación gastrointestinal es rara y la clínica asociada dependerá de la localización, la extensión y el mecanismo de infiltración. La afectación gástrica en forma de tumoración tiene un aspecto y una sintomatología similares a los de otras lesiones, por lo que es necesario realizar un diagnóstico histológico para un adecuado tratamiento. A continuación se presenta el caso de un mieloma múltiple con afectación gástrica.Multiple myeloma is characterized by medullary neoplastic proliferation of plasma cells producing monoclonal immunoglobulin. A small percentage of patients have extramedullary involvement in form of plasmacytoma, the most common location being the upper respiratory tract. Gastrointestinal involvement is rare and the associated symptoms will depend on the location, extent and mechanism of infiltration. Gastric involvement presents an appearance and symptoms similar to other lesions, so a histological diagnosis is necessary for proper treatment. This article presents the case of multiple myeloma with gastric involvement.

Late anastomotic leakages in rectal surgery: a wake-up call about their impact on long-term results.

OBJECTIVE: To assess the impact of the incidence of late anastomotic dehiscences, defined as those occurring after the 60th post-operative day, in the final results of rectal cancer treatment. METHODS: A retrospective analysis was performed reviewing all anastomotic leakages (AL) recorded in a prospective rectal cancer database, from November 2006 to December 2015. RESULTS: The analysis included 395 (71.5%) colo-rectal anastomosis performed in 552 patients undergoing rectal cancer surgery. Overall 32 (8.1%). AL were identified: 25 (78%) early and 7 (22%) late. Late AL compared to early AL were significantly associated with: higher ASA score (p = 0.021), higher CLS score (p = 0.005), lower rectal tumours (p = 0.014), neo-adjuvant radio-chemotherapy (p = 0.028), presence of ileostomy (p = 0.013), early hospital discharge (p = 0.048) and with the need for definitive stoma creation (p = 0.003). CONCLUSIONS: Late AL can represent up to 22% of all AL; with significant long-term implications such as an increase of the requirement of definitive stoma or chronic pelvic sepsis. This findings could modify the long-term outcomes in rectal cancer published. In our experience, the late AL do not represent a distinct clinical process compared to early forms, with exception of the chronological criteria.

OBJETIVO: Valorar el impacto de la incidencia de dehiscencias anastomóticas tardías, definidas como las aparecidas después del día 60 del posoperatorio, en los resultados finales del tratamiento del cáncer de recto. MÉTODO: Estudio retrospectivo de todas las dehiscencias anastomóticas recogidas a largo plazo en un registro prospectivo de cáncer de recto entre noviembre de 2006 y diciembre de 2015. RESULTADOS: Se realizaron 395 anastomosis colorrectales en 552 pacientes con cáncer de recto (71.5%) y se diagnosticaron 32 dehiscencias anastomóticas (8.1%): 25 precoces (78%) y 7 tardías (22%). Las tardías se diferenciaron de las precoces por presentarse en pacientes con mayor puntuación ASA (p = 0.021), mayor puntuación predictiva CLS (p = 0.005), tumores más bajos (p = 0.014), neoadyuvancia (p = 0.028), ileostomía (p = 0.013), menos tiempo de estancia posoperatoria (p = 0.048) y mayor necesidad de estomas definitivos (p = 0.003). CONCLUSIONES: Las dehiscencias anastomóticas tardías pueden suponer el 22% de las dehiscencias totales y se acompañan de un aumento de estomas definitivos y de sepsis pélvica crónica que podrían empeorar los estándares publicados en cáncer de recto. En nuestra experiencia no son diferentes de las formas precoces salvo en su cronología.

Patrones de recurrencia/persistencia en la operación de LIFT para la fístula anal de origen criptoglandular. Estudio observacional a largo plazo / Patterns of recurrence/persistence of criptoglandular anal fistula after the LIFT procedure. Long-term observacional study

Objetivo: Valorar la recidiva/persistencia de la fístula anal compleja tras cirugía de tipo LIFT y analizar los patrones de recurrencia/persistencia. Pacientes y método: Estudio observacional de pacientes afectos de fístula anal transesfinteriana o supraesfinteriana tratada mediante la técnica LIFT durante el periodo diciembre de 2008-abril de 2016. Se analizan las características clínicas, la técnica quirúrgica y su resultado. Se define la curación clínica y se emplean pruebas de imagen en casos de duda. Se utiliza la escala Wexner para el estudio de la continencia. El tiempo mínimo de seguimiento ha sido de un año. Resultados: Un total de 55 pacientes fueron intervenidos: 53 con fístula transesfinteriana y 2 supraesfinteriana. Se produjeron 16 fracasos (29%): 7 fístulas completas (originales), 6 interesfinterianas (downstage) y 3 trayecto residuales externos. La localización posterior y la complejidad del trayecto fueron factores de riesgo de recurrencia/persistencia. La presencia de un sedal previo no mejoró los resultados. Ningún caso presentó alteración de la continencia (Wexner 0). Del total, 9 pacientes presentaron complicaciones leves (9%): 4 heridas interesfinterianas con cierre tardío y una trombosis hemorroidal externa. La mediana del cierre del orificio externo fue de 5 semanas (RI: 2-6). Las heridas interesfinterianas curaron en 4-8 semanas. Conclusión: La técnica de LIFT en nuestra experiencia ha resultado una operación segura, reproductible, con escasa morbilidad, nula repercusión en la continencia y un porcentaje de éxito superior al 70%. Se definen 3 tipos de recurrencia: la fístula interesfinteriana, la fístula original (trans- o supraesfinteriana) y el trayecto externo residual. Considerando los tipos de recurrencia, tan solo el 12,7% de los pacientes han necesitado cirugías más complejas para solucionar esta entidad. El resto de las recurrencias/persistencias se han solucionado con gestos simples (fistulotomía en la formas interesfinterianas y legrados en los trayectos residuales) (AU)

Objective: To study the recurrence/persistence rate of complex cripotoglandular anal fistula after the LIFT procedure and analyse the patterns of recurrence/persistence. Patients and methods: Observational study of patients with transe-sphincteric or supra-sphincteric anal fistula treated using the LIFT procedure from December 2008 to April 2016. Variables studied included clinical characteristics, surgical technique and results. Clinical cure was defined and imaging studies were used in doubtful cases. Wexner's score was used for continence evaluation. The minimum follow-up time was one year. Results A total of 55 patients were operated on: 53 with a trans-sphincteric fistula and 2 supra-sphincteric. There were 16 failures (29%): 7 complete fistulas (original), 6 intersphincteric (downstage), and 3 external residual tracts. A posterior location and complexity of the tract were risk factors for recurrence/persistence. The presence of a seton did not improve results. No case presented decrease of continence (Wexner 0). Nine patients presented minor complications (9%): 4 intersphincteric wounds with delayed closure and one external hemorrhoidal thrombosis. The median time to closure of the external opening was 5 weeks (IR 2-6). Intersphincteric wounds closed in 4-8 weeks. Conclusion: In our experience, the LIFT technique is a safe and reproducible procedure with low morbidity, no repercussion on continence and a success rate over 70%. There are 3 types of recurrence: the intersphincteric fistula, the original fistulatula (trans- or supra-sphincteric) and the residual external tract. Considering the types of recurrence, only 12,7% of patients need more complex surgery to solve their pathology. The rest of the recurrences/persistence were solved by simple procedures (fistulotomy in intersphincteric forms and legrado in residual tracts) (AU)

Patterns of recurrence/persistence of criptoglandular anal fistula after the LIFT procedure. Long-term observacional study. / Patrones de recurrencia/persistencia en la operación de LIFT para la fístula anal de origen criptoglandular. Estudio observacional a largo plazo.

OBJECTIVE: To study the recurrence/persistence rate of complex cripotoglandular anal fistula after the LIFT procedure and analyse the patterns of recurrence/persistence. PATIENTS AND METHODS: Observational study of patients with transe-sphincteric or supra-sphincteric anal fistula treated using the LIFT procedure from December 2008 to April 2016. Variables studied included clinical characteristics, surgical technique and results. Clinical cure was defined and imaging studies were used in doubtful cases. Wexner's score was used for continence evaluation. The minimum follow-up time was one year. RESULTS: A total of 55 patients were operated on: 53 with a trans-sphincteric fistula and 2 supra-sphincteric. There were 16 failures (29%): 7 complete fistulas (original), 6 intersphincteric (downstage), and 3 external residual tracts. A posterior location and complexity of the tract were risk factors for recurrence/persistence. The presence of a seton did not improve results. No case presented decrease of continence (Wexner 0). Nine patients presented minor complications (9%): 4 intersphincteric wounds with delayed closure and one external hemorrhoidal thrombosis. The median time to closure of the external opening was 5 weeks (IR 2-6). Intersphincteric wounds closed in 4-8 weeks. CONCLUSION: In our experience, the LIFT technique is a safe and reproducible procedure with low morbidity, no repercussion on continence and a success rate over 70%. There are 3types of recurrence: the intersphincteric fistula, the original fistulatula (trans- or supra-sphincteric) and the residual external tract. Considering the types of recurrence, only 12,7% of patients need more complex surgery to solve their pathology. The rest of the recurrences/persistence were solved by simple procedures (fistulotomy in intersphincteric forms and legrado in residual tracts).

Results of short term radiotherapy followed by radical surgery for rectal cancer: A long-term unicenter observational study. / Resultados de la radioterapia de ciclo corto seguida de cirugía radical en el cáncer de recto: estudio unicéntrico y observacional a largo plazo.

INTRODUCTION: Short-term radiotherapy (STR) for rectal cancer (RC) has rarely been used in Spain. The aim of the present study is to describe oncological results after RTC and surgery for RC. METHODS: This is a retrospective analysis of a consecutive series of patients treated with STR and surgery for RC (1999-2012). Epidemiological data, staging, complications of STR, STR-surgery interval, surgical approach, rate of anastomotic/perineal wound dehiscence, and pathological data (regression degree and staging) were collected. Global survival, disease free survival, local recurrence rate and incidence of toxicity, response and complications of combined treatment are reported. RESULTS: Of 1229 patients treated, 209 patients received STR and surgery. The median follow-up was 6.2 years. Mean age was 68 years and 66% of the patients were men. A total of 88% were cT3-4 and 44% cN+17 (8.1%) patients had resectable synchronous metastases. Acute and chronic toxicity due to STR was <5%. In 75% of the cases the STR-surgery interval was <15 days, and in 9%> 4 weeks. Seven patients (3.3%) presented complete response. Nine (4.3%) patients presented an local recurrence rate. Global survival at 5, 10 and 15 years was 67.8, 49.2 and 37.5%, respectively. Disease free survival at 5, 10 and 15 years was 66.1, 47.1 and 33%, respectively. CONCLUSIONS: The results compare favorably with multicentric historical series. STR offers certain advantages that could be increased by increasing the STR-surgery interval and/or interspersed with sequential chemotherapy.

Resultados de la radioterapia de ciclo corto seguida de cirugía radical en el cáncer de recto: estudio unicéntrico y observacional a largo plazo / Results of short term radiotherapy followed by radical surgery for rectal cancer: A long-term unicenter observational study

Introducción: La radioterapia preoperatoria corta (RTC) para el tratamiento del cáncer de recto (CR) ha sido poco utilizada en España. El objetivo del presente trabajo es describir los resultados oncológicos tras tratamiento con RTC y cirugía por CR. Métodos: Estudio retrospectivo que incluye una serie consecutiva de pacientes tratados por CR (1999-2012). Se recogieron datos epidemiológicos, estadificación, complicaciones de la RTC, intervalo RTC-cirugía, abordaje quirúrgico, tasa de dehiscencia de anastomosis o herida perineal e histológicos (grado de regresión y estadificación). Se analizan la supervivencia global, supervivencia libre de enfermedad, tasa de recurrencia local e incidencia de toxicidad, respuesta y complicaciones del tratamiento combinado con RTC y cirugía. Resultados: De 1.229 pacientes tratados, 209 pacientes recibieron RTC y cirugía. La mediana de seguimiento fue de 6,2 años. La edad media fue de 68 años y el 66% fueron hombres. El 88% eran cT3-4 y el 44% cN+. Un total de 17 pacientes (8,1%) tenían metástasis síncronas resecables. La toxicidad aguda y crónica por RTC fue inferior al 5%. En el 75% de los pacientes el intervalo RTC-cirugía fue inferior a 15 días y en el 9%, superior a 4 semanas. Fueron 7 los pacientes (3,3%) que presentaron respuesta completa. La mediana de supervivencia fue de casi 10 años. Nueve (4,3%) pacientes presentaron una recurrencia local. La supervivencia global a 5, 10 y 15 años fue del 67,8, 49,2 y 37,5%, respectivamente. La supervivencia libre de enfermedad a 5, 10 y 15 años fue del 66,1; 47,1 y 33%, respectivamente. Conclusiones: Los resultados se comparan favorablemente con las series históricas multicéntricas. La RTC ofrece ciertas ventajas que pueden ampliarse incrementando el intervalo RTC-cirugía o si se intercala con quimioterapia secuencial (AU)

Introduction: Short-term radiotherapy (STR) for rectal cancer (RC) has rarely been used in Spain. The aim of the present study is to describe oncological results after RTC and surgery for RC. Methods: This is a retrospective analysis of a consecutive series of patients treated with STR and surgery for RC (1999-2012). Epidemiological data, staging, complications of STR, STR-surgery interval, surgical approach, rate of anastomotic/perineal wound dehiscence, and pathological data (regression degree and staging) were collected. Global survival, disease free survival, local recurrence rate and incidence of toxicity, response and complications of combined treatment are reported. Results: Of 1229 patients treated, 209 patients received STR and surgery. The median follow-up was 6.2 years. Mean age was 68 years and 66% of the patients were men. A total of 88% were cT3-4 and 44% cN+17 (8.1%) patients had resectable synchronous metastases. Acute and chronic toxicity due to STR was <5%. In 75% of the cases the STR-surgery interval was <15 days, and in 9%> 4 weeks. Seven patients (3.3%) presented complete response. Nine (4.3%) patients presented an local recurrence rate. Global survival at 5, 10 and 15 years was 67.8, 49.2 and 37.5%, respectively. Disease free survival at 5, 10 and 15 years was 66.1, 47.1 and 33%, respectively. Conclusions: The results compare favorably with multicentric historical series. STR offers certain advantages that could be increased by increasing the STR-surgery interval and/or interspersed with sequential chemotherapy (AU)

Influencia del volumen quirúrgico en los resultados oncológicos después de estandarizar la cirugía en el Proyecto Español del Cáncer de Recto / Effect of hospital caseload on long-term outcome after standardization of rectal cancer surgery in the Spanish Rectal Cancer Project

INTRODUCCIÓN: Determinar la influencia del volumen quirúrgico en los resultados oncológicos del Proyecto del Cáncer de Recto de la Asociación Española de Cirujanos. MÉTODOS: Se incluyeron 2.910 pacientes consecutivos tratados con una operación curativa entre marzo de 2006 y marzo de 2010 en 36 hospitales. Los hospitales se clasificaron según el número de pacientes operados por año en: pequeños (12-23), intermedios (24-35) y grandes (≥ 36). RESULTADOS: Con un seguimiento de al menos cinco años la incidencia acumulada de recidiva local fue 6,6 (IC 95% 5,6-7,6), la de metástasis 20,3 (IC 95% 18,8-21,9) y la de supervivencia global 73,0 (IC 95% 74,7-71,3). En el análisis de regresión multinivel, la supervivencia global fue mayor en los hospitales que operaban 36 o más pacientes [HR 0,727 (IC 95% 0,556-0,951); p = 0,02]. El riesgo de recidiva local y metástasis no se relacionó con el volumen quirúrgico. Además, hubo una variación significativa en las tasas de supervivencia global (mediana hazard ratio [MHR] 1,184 [IC 95% 1,071-1,333]), recidiva local (MHR 1,308 [IC 95% 1,010-1,668]) y metástasis (MHR 1,300 [IC 95% 1,181-1,476]) entre todos los hospitales. CONCLUSIONES: En los grupos multidisciplinares seleccionados e incluidos en el proyecto de la Asociación Española de Cirujanos, que incluye la enseñanza de la escisión total del mesorrecto y la realimentación de los resultados, la supervivencia global es mayor en los hospitales con mayor volumen quirúrgico, y la variabilidad interhospitalaria de la tasa de recidiva local no se explica por el volumen quirúrgico

INTRODUCCIÓN: The purpose of this prospective multicentre multilevel study was to investigate the influence of hospital caseload on long-term outcomes following standardization of rectal cancer surgery in the Rectal Cancer Project of the Spanish Society of Surgeons. METHODS: Data relating to 2910 consecutive patients with rectal cancer treated for cure between March 2006 and March 2010 were recorded in a prospective database. Hospitals were classified according to number of patients treated per year as low-volume, intermediate-volume, or high volume hospitals (12-23, 24-35, or ≥ 36 procedures per year). RESULTS: After a median follow-up of 5 years, cumulative rates of local recurrence, metastatic recurrence and overall survival were 6.6 (CI 95% 5.6-7.6), 20.3 (CI 95% 18.8-21.9) and 73.0 (CI95% 74.7 - 71.3) respectively. In the multilevel regression analysis overall survival was higher for patients treated at hospitals with an annual caseload of 36 or more patients (HR 0,727 [CI 95% 0,556-0,951]; P=.02). The risk of local recurrence and metastases were not related to the caseload. Moreover, there was a statistically significant variation in overall survival (median hazard ratio [MHR] 1.184 [CI 95% 1.071-1,333]), local recurrence (MHR 1.308 [CI 95% 1.010-1.668]) and metastases (MHR 1.300 [CI 95% 1.181; 1.476]) between all hospitals. CONCLUSIONS: Overall survival was higher for patients treated at hospitals with an annual caseload of 36 or more PATIENTS: However, local recurrence was not influenced by caseload

Effect of hospital caseload on long-term outcome after standardization of rectal cancer surgery in the Spanish Rectal Cancer Project. / Influencia del volumen quirúrgico en los resultados oncológicos después de estandarizar la cirugía en el Proyecto Español del Cáncer de Recto.

UNLABELLED: INTRODUCCIóN: The purpose of this prospective multicentre multilevel study was to investigate the influence of hospital caseload on long-term outcomes following standardization of rectal cancer surgery in the Rectal Cancer Project of the Spanish Society of Surgeons. METHODS: Data relating to 2910 consecutive patients with rectal cancer treated for cure between March 2006 and March 2010 were recorded in a prospective database. Hospitals were classified according to number of patients treated per year as low-volume, intermediate-volume, or high volume hospitals (12-23, 24-35, or ≥36 procedures per year). RESULTS: After a median follow-up of 5 years, cumulative rates of local recurrence, metastatic recurrence and overall survival were 6.6 (CI95% 5.6-7.6), 20.3 (CI95% 18.8-21.9) and 73.0 (CI95% 74.7 - 71.3) respectively. In the multilevel regression analysis overall survival was higher for patients treated at hospitals with an annual caseload of 36 or more patients (HR 0,727 [CI95% 0,556-0,951]; P=.02). The risk of local recurrence and metastases were not related to the caseload. Moreover, there was a statistically significant variation in overall survival (median hazard ratio [MHR] 1.184 [CI95% 1.071-1,333]), local recurrence (MHR 1.308 [CI95% 1.010-1.668]) and metastases (MHR 1.300 [CI95% 1.181; 1.476]) between all hospitals. CONCLUSIONS: Overall survival was higher for patients treated at hospitals with an annual caseload of 36 or more patients. However, local recurrence was not influenced by caseload.

Variabilidad interhospitalaria de la mortalidad postoperatoria en el proyecto del cáncer de recto de la Asociación Española de Cirujanos. La influencia del volumen quirúrgico / Hospital variability in postoperative mortality after rectal cancer surgery in the Spanish association of surgeons project: The impact of hospital volume

INTRODUCCIÓN: El objetivo de este estudio observacional multicéntrico ha sido examinar la variación de la mortalidad postoperatoria de la cirugía electiva entre los hospitales que participan en el Proyecto del Cáncer de Recto de la Asociación Española de Cirujanos, y evaluar si el volumen quirúrgico anual del hospital y las características de los pacientes contribuyen a la variación entre los hospitales. MÉTODOS: La variación interhospitalaria se cuantificó mediante un estudio multinivel realizado con una base de datos prospectiva de los pacientes operados por un adenocarcinoma de recto con una resección anterior y una amputación abdominoperineal en 84 hospitales, entre marzo de 2006 y diciembre de 2013. En los análisis se incluyeron: las variables demográficas, la clasificación ASA, la localización y el estadio del tumor, la administración de tratamiento neoadyuvante y el volumen quirúrgico anual del hospital. RESULTADOS: Se analizó a 9.809 pacientes operados consecutivamente. La tasa de mortalidad operatoria fue 1,8%. Los porcentajes de mortalidad de los hospitales estratificados por el volumen quirúrgico anual variaron entre 1,4 y 2,0%. En el análisis de regresión multinivel, el sexo masculino (OR 1,623 [1,143; 2,348]; p < 0,008), la edad avanzada (OR 5,811 [3,479; 10,087)]; p < 0,001) y la puntuación del ASA (OR 10,046 [3,390; 43,185]; p < 0,001) se asociaron con la mortalidad a los 30 días de la operación. Sin embargo, el volumen quirúrgico anual del hospital no se asoció con la mortalidad (OR 1,309 [0,483; 4,238]; p = 0,619). Además, se observó una variación significativa de la mortalidad entre los hospitales (MOR 1,588 [1,293; 2,015]; p < 0,001). CONCLUSIÓN:La mortalidad operatoria varía de forma estadísticamente significativa entre los hospitales incluidos en el proyecto, y esta diferencia no se puede atribuir al volumen quirúrgico anual

OBJECTIVE: This multicentre observational study examines variation between hospitals in postoperative mortality after elective surgery in the Rectal Cancer Project of the Spanish Society of Surgeons and explores whether hospital volume and patient characteristics contribute to any variation between hospitals. METHODS: Hospital variation was quantified using a multilevel approach on prospective data derived from the multicentre database of all rectal adenocarcinomas operated by an anterior resection or an abdominoperineal excision at 84 surgical departments from 2006 to 2013. The following variables were included in the analysis; demographics, American Society of Anaesthesiologists classification, tumour location and stage, administration of neoadjuvant treatment, and annual volume of surgical procedures. RESULTS: A total of 9809 consecutive patients were included. The rate of 30-day postoperative mortality was 1.8% Stratified by annual surgical volume hospitals varied from 1.4 to 2.0 in 30-day mortality. In the multilevel regression analysis, male gender (OR 1.623 [1.143; 2.348]; P < .008), increased age (OR: 5.811 [3.479; 10.087]; P < .001), and ASA score (OR 10.046 [3.390; 43.185]; P < .001) were associated with 30-day mortality. However, annual surgical volume was not associated with mortality (OR 1.309 [0.483; 4.238]; P = .619). Besides, there was a statistically significant variation in mortality between all departments (MOR 1.588 [1.293; 2.015]; P < .001). CONCLUSION: Postoperative mortality varies significantly among hospitals included in the project and this difference cannot be attributed to the annual surgical volume