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BACKGROUND: Patients with IBD are at increased risk for developing colorectal cancer. However, overall survival and disease-free survival for rectal cancer alone in patients with IBD has not been reported. OBJECTIVE: This study aimed to determine overall survival and disease-free survival for patients with rectal cancer in IBD versus non-IBD cohorts. DESIGN: This is a retrospective cohort study. SETTING: This study was conducted at an IBD referral center. PATIENTS: All consecutive adult patients with IBD diagnosed with rectal cancer and at least 1 year of postsurgery follow-up were included and matched in a 1:2 fashion (age, sex, preoperative stage) with patients with rectal cancer who did not have IBD. MAIN OUTCOMES MEASURES: Five-year overall survival and disease-free survival, 30-day postoperative complication, readmission, reoperation, and mortality rates were measured. METHODS: Survival rates were calculated using Kaplan-Meier estimates. The association of risk factors and long-term outcomes was assessed using Cox proportion hazard models. RESULTS: A total of 107 study patients with IBD who had rectal cancer were matched to 215 control patients; preoperative stages were as follows: 31% with stage I, 19% with stage II, 40% with stage III, and 10% with stage IV. Differences were observed (IBD vs non-IBD) in neoadjuvant chemotherapy (33.6% vs 52.6%, p = 0.001) and preoperative radiotherapy (35.5% vs 53.5%, p = 0.003). Postoperative complication rates were similar. On surgical pathology, patients with IBD had more lymphovascular invasion (12.9% vs 5.6%, p = 0.04) and positive circumferential resection margins (5.4% vs 0.9%, p = 0.03). On multivariable analysis, the diagnosis of IBD did not significantly impact long-term mortality (HR, 0.91; 95% CI, 0.53–1.57; p = 0.73) or disease-free survival (HR, 1.36; 95% CI, 0.84–2.21; p = 0.22). LIMITATIONS: This study was limited by its retrospective design and the use of single-center data. CONCLUSIONS: Patients have rectal cancer with IBD and without IBD have similar long-term and disease-free survival, despite lower rates of neoadjuvant treatment and higher margin positivity in patients with IBD. See Video Abstract at http://links.lww.com/DCR/B271. ¿LA ENFERMEDAD INFLAMATORIA INTESTINAL ACARREA PEORES RESULTADOS EN PACIENTES CON CÁNCER RECTAL? UN ANÁLISIS DE CASOS-COINCIDENTES ANTECEDENTES: Los pacientes con enfermedad inflamatoria intestinal (EII) tienen un mayor riesgo de desarrollar cáncer colorrectal. Sin embargo, no se ha informado la supervivencia general y la supervivencia libre de enfermedad para el cáncer rectal solo en pacientes con EII. OBJETIVO: Determinar la supervivencia general y la supervivencia libre de enfermedad para pacientes con cáncer rectal en cohortes con EII versus sin EII. DISEÑO: Estudio de cohorte retrospectivo. MARCO: Centro de referencia para enfermedad inflamatoria intestinal. PACIENTES: todos los pacientes adultos con EII diagnosticados con cáncer rectal, consecutives, y al menos un año de seguimiento postoperatorio se incluyeron y se emparejaron de manera 1: 2 (edad, sexo, etapa preoperatoria) con pacientes con cáncer rectal sin EII. MEDIDAS DE RESULTADO PRINCIPALES: Se midieron la supervivencia general a cinco años y la supervivencia libre de enfermedad, complicaciones postoperatorias a los 30 días, reingreso, reoperación y tasas de mortalidad. MÉTODOS: Las tasas de supervivencia se calcularon utilizando estimaciones de Kaplan-Meier. La asociación de factores de riesgo y resultados a largo plazo se evaluó mediante modelos de riesgo de proporción de Cox. RESULTADOS: Un total de 107 pacientes con EII y cáncer rectal se compararon con 215 pacientes de control; las etapas preoperatorias fueron las siguientes: 31% de Etapa I, 19% de Etapa II, 40% de Etapa III y 10% de Etapa IV. Se observaron diferencias (EII versus no EII) en quimioterapia neoadyuvante (33.6% frente a 52.6%, p = 0.001) y radioterapia preoperatoria (35.5% frente a 53.5%, p = 0.003). Las tasas de complicaciones postoperatorias fueron similares. En la patología quirúrgica, los pacientes con EII tuvieron más invasión linfovascular (12.9% frente a 5.6%, p = 0.04) y márgenes de resección circunferencial positivos (5.4% frente a 0.9%, p = 0.03). En el análisis multivariable, el diagnóstico de EII no tuvo un impacto significativo en la mortalidad a largo plazo (HR 0.91; IC del 95%: 0.53-1.57, p = 0.73) o la supervivencia libre de enfermedad (HR 1.36; IC del 95%: 0.84-2.21, p = 0.22) LIMITACIONES: Diseño retrospectivo, centro único de datos. CONCLUSIONES: Los pacientes con EII y sin EII con cáncer rectal tienen una supervivencia similar a largo plazo y libre de enfermedad, a pesar de las tasas más bajas de tratamiento sneoadyuvante y un mayor margen positivo en pacientes con EII. Consulte Video Resumen en http://links.lww.com/DCR/B271.

BACKGROUND: There is no study to date examining the safety of initiating or restarting biologic therapy after major abdominal surgery for Crohn’s disease. OBJECTIVE: The purpose of this study was to determine differences in the rates of 90-day superficial surgical site infections, intra-abdominal sepsis, and overall postoperative infectious complications among patients who were initiated on or restarted a biologic within 90 days postoperatively compared with those who were not. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted at an IBD referral center. PATIENTS: Adult patients with Crohn’s disease who received a biologic therapy within 90 days of a major abdominal operation between May 20, 2014, and December 31, 2018, were included. MAIN OUTCOMES MEASURES: Ninety-day superficial surgical site infection, intra-abdominal sepsis, and overall postoperative infectious complications were measured. RESULTS: A total of 680 patients with Crohn’s disease were included: 351 were initiated on biologic therapy within 90 days after surgery and 329 were not. Patients exposed to biologic therapy postoperatively were younger (p < 0.001), had a lower BMI (p = 0.0014), were less often diabetic (p = 0.0011), and were more often exposed preoperatively to biologics (p < 0.0001) and immunomodulators (p < 0.0001) but not corticosteroids (p = 0.8399). Of those exposed postoperatively, nearly all (93.7%) had been on a biologics preoperatively, and most resumed the same biologic (68.0%). The median time to starting biologic therapy postoperatively was 31 days (range, 7–89 d). Postoperative biologic exposure was not associated with an increased risk of superficial surgical site infection (HR = 1.02 (95% CI, 0.95–1.09) per week; p = 0.59), intra-abdominal sepsis (HR = 1.07 (95% CI, 0.99–1.16); p = 0.73), or overall postoperative infectious complications (HR = 1.02 (95% CI, 0.98–1.07); p = 0.338); the overall rates of each at 90 days was 13%, 8%, and 28%. LIMITATIONS: The study was limited by its retrospective design and single-center data. CONCLUSIONS: Postoperative initiation or resumption of biologic therapy did not increase 90-day rates of superficial surgical site infection, intra-abdominal sepsis, or total infectious complications after major abdominal surgery for Crohn’s disease. See Video Abstract at http://links.lww.com/DCR/B207. ¿SON SEGUROS LOS FÁRMACOS BIOLÓGICOS EN EL POSTOPERATORIO INMEDIATO? UNA EVALUACIÓN DE UN SOLO CENTRO DE PACIENTES QUIRÚRGICOS CONSECUTIVOS CON ENFERMEDAD DE CROHN ANTECEDENTES: No hay ningún estudio hasta la fecha que examine la seguridad de iniciar o reiniciar la terapia biológica después de una cirugía abdominal mayor en enfermedad de Crohn. OBJETIVO: Determinar las diferencias en las tasas a 90 días de infecciones del sitio quirúrgico superficial, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales entre los pacientes en que se inició o reinició un biológico dentro de los 90 días después de la operación en comparación con aquellos que no lo recibieron. DISEÑO: Estudio de cohorte retrospectivo. ESCENARIO: Centro de referencia de enfermedad inflamatoria intestinal. PACIENTES: Pacientes adultos con enfermedad de Crohn que recibieron una terapia biológica dentro de los 90 días de una operación abdominal mayor entre el 20 de mayo de 2014 y el 31 de diciembre de 2018. PRINCIPALES MEDIDAS DE RESULTADO: Infección superficial del sitio quirúrgico, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales a 90 días. RESULTADOS: Se incluyeron un total de 680 pacientes con enfermedad de Crohn: 351 se iniciaron en terapia biológica dentro de los 90 días posteriores a la cirugía y 329 no. Los pacientes expuestos a terapia biológica después de la operación eran más jóvenes (p <0.001), tenían un índice de masa corporal más bajo (p = 0.0014), eran con menos frecuencia diabéticos (p = 0.0011) y estaban expuestos con mayor frecuencia preoperatoriamente a fármacos biológicos (p <0.0001) e inmunomoduladores (p <0.0001) pero no a corticosteroides (p = 0.8399). De los expuestos postoperatoriamente, casi todos (93.7%) habían estado en terapia biológica en el preoperatorio, y la mayoría reanudó la misma terapia biológica (68%). La mediana de tiempo para comenzar la terapia biológica después de la operación fue de 31 días (rango, 7-89 días). La exposición biológica postoperatoria no se asoció con un mayor riesgo de infección superficial del sitio quirúrgico (HR 1.02 (0.95-1.09) por semana, p = 0.59), sepsis intraabdominal. (HR: 1.07 (0.99-1.16), p = 0.73), o complicaciones infecciosas postoperatorias generales (HR: 1.02, intervalo de confianza del 95% 0.98-1.07, p = 0.338); las tasas generales de cada uno a los 90 días fue del 13%, 8% y 28%. LIMITACIONES: Diseño retrospectivo, y datos de un centro único. CONCLUSIONES: El inicio o la reanudación en el postoperatorio de la terapia biológica no aumentaron las tasas a 90 días de infección superficial de sitio quirúrgico, sepsis intraabdominal o complicaciones infecciosas totales después de una cirugía abdominal mayor por enfermedad de Crohn. Consulte el Video Resumen en http://links.lww.com/DCR/B207. (Traducción—Dr Jorge Silva Velazco)

BACKGROUND: The evidence regarding the association of preoperative biologic exposure and postoperative outcomes remains controversial for both antitumor necrosis factor agents and vedolizumab and largely unknown for ustekinumab. OBJECTIVE: The purpose of this study was to determine differences in the rates of 30-day postoperative overall infectious complications and intra-abdominal septic complications among the 3 classes of biologic therapies as compared with no biologic therapy. DESIGN: This was a retrospective review. SETTINGS: The study was conducted at an IBD referral center. PATIENTS: Adult patients with Crohn’s disease who received an antitumor necrosis factor, vedolizumab, ustekinumab, or no biologic therapy within 12 weeks of a major abdominal operation between May 20, 2014, and December 31, 2017, were included. MAIN OUTCOMES MEASURES: Thirty-day overall postoperative infectious complications and intra-abdominal septic complications were measured. RESULTS: A total of 712 patients with Crohn’s disease were included; 272 patients were exposed to an antitumor necrosis factor agents, 127 to vedolizumab, 38 to ustekinumab, and 275 to no biologic therapy within the 12 weeks before an abdominal operation. Patients exposed to a biologic were more likely to be taking a concurrent immunomodulator, but there was no difference in concurrent corticosteroid usage. The particular class of biologic was not independently associated with total overall infectious complications. Vedolizumab was associated with an increased rate of intra-abdominal sepsis on univariate analysis but not on multivariable analysis. Combination immunosuppression was associated with both an increased rate of overall postoperative infectious complications and intra-abdominal sepsis. LIMITATIONS: The study was limited by its retrospective design and single-center data. CONCLUSIONS: The overall rate of total infectious complications or intra-abdominal septic complications was not increased based on preoperative exposure to a particular class of biologic. Rates increased with combination immunosuppression of biologic therapy with corticosteroids and previous abdominal resection. See Video Abstract at http://links.lww.com/DCR/B24. BIOLÓGICOS Y COMPLICACIONES POSTOPERATORIAS DE 30 DÍAS DESPUÉS DE LAS OPERACIONES ABDOMINALES PARA LA ENFERMEDAD DE CROHN: ¿EXISTEN DIFERENCIAS EN LOS PERFILES DE SEGURIDAD?: ANTECEDENTES: La evidencia sobre la asociación de la exposición biológica preoperatoria y los resultados postoperatorios sigue siendo controvertida controversial tanto para los agentes del factor de necrosis tumoral (anti-TNF) como para el vedolizumab, y en gran parte desconocida para el ustekinumab. OBJETIVO: Determinar las diferencias en las tasas de complicaciones infecciosas generales postoperatorias de 30 días y complicaciones sépticas intraabdominales entre las tres clases de terapias biológicas en comparación con ninguna terapia biológica. DISEÑO: Revisión retrospectiva. AMBIENTE: centro de referencia de la enfermedad inflamatoria intestinal. PACIENTES: Pacientes adultos con enfermedad de Crohn que recibieron un factor de necrosis antitumoral, vedolizumab, ustekinumab o ningún tratamiento biológico dentro de las 12 semanas de una operación abdominal mayor entre el 5/20/2014 y el 12/31/2017. PRINCIPALES MEDIDAS DE RESULTADOS: Complicaciones infecciosas postoperatorias generales de 30 días, complicaciones sépticas intraabdominales. RESULTADOS: Se incluyeron setecientos doce pacientes con enfermedad de Crohn; 272 pacientes fueron expuestos a un anti-TNF, 127 a vedolizumab, 38 a ustekinumab y 275 a ninguna terapia biológica dentro de las 12 semanas previas a una operación abdominal. Los pacientes expuestos a un producto biológico tenían más probabilidades de tomar un inmunomodulador concurrente, pero no hubo diferencias en el uso simultáneo de corticosteroides. La clase particular de productos biológicos no se asoció de forma independiente con las complicaciones infecciosas totales. Vedolizumab se asoció con una mayor tasa de sepsis intraabdominal en el análisis univariable, pero no en el análisis multivariable. La inmunosupresión combinada se asoció tanto con una mayor tasa de complicaciones infecciosas postoperatorias generales como con sepsis intraabdominal. LIMITACIONES: Diseño retrospectivo, datos de centro único. CONCLUSIONES: La tasa general de complicaciones infecciosas totales o complicaciones sépticas intraabdominales no aumentó en función de la exposición preoperatoria a una clase particular de productos biológicos. Las tasas aumentaron con la combinación de inmunosupresión de la terapia biológica con corticosteroides y resección abdominal previa. Vea el Resumen del Video en http://links.lww.com/DCR/B24.

Abstract Introduction The impact of ustekinumab on adverse postoperative outcomes in Crohn’s disease (CD) remains largely unknown. We determined the difference in 90-day postoperative complication rates among CD patients exposed to ustekinumab within 12 weeks prior to an abdominal operation as compared to patients not exposed to biologic therapy. Methods A retrospective chart review of all adults with CD who underwent an abdominal operation between October 1, 2017 and December 31, 2018 at a single tertiary medical center was performed. Data collection included patient demographics, concurrent immunosuppression, serum laboratory values, operative values, and 90-day outcomes including superficial surgical site infection (sSSI), intra-abdominal sepsis, overall infectious complications, readmission, and reoperation rates. The primary outcome was the 90-day rate of intra-abdominal sepsis. Results Fifty-seven CD patients received ustekinumab and 277 received no biologic therapy in the 12 weeks prior to major abdominal surgery. Ustekinumab-exposed patients were younger, less likely to have diabetes mellitus or active tobacco exposure, were more often obese, and more often taking a concurrent immunomodulator. Ustekinumab remained an independent predictor of intra-abdominal sepsis on multivariable logistic regression. Immunomodulator exposure was associated with significantly increased rates of sSSI and overall complication rates. Conclusions Ustekinumab is associated with increased rates of 90-day postoperative intra-abdominal sepsis following a major abdominal operation for CD.

BACKGROUND: Limited knowledge exists as to what impact preoperative biologic therapy has on post-operative complications in pediatric patients undergoing abdominal surgery for Crohn's disease (CD). Therefore, we sought to determine the 30-day postoperative infectious complication rate among pediatric CD patients who received biologic therapy within 12 weeks of an abdominal operation. METHODS: A retrospective chart review was performed on pediatric (<18 years of age) CD patients who underwent an abdominal operation between 1/1/2008 and 12/31/2017. Patients were grouped according to whether they received an anti-TNF (infliximab, adalimumab, certolizumab pegol) or no biologic therapy within 12 weeks prior to the operation. The primary outcome was a the overall 30-day postoperative infectious complication rate. Secondary outcomes included 30-day readmission rate and return to the operating room (ROR). RESULTS: A total of 69 pediatric CD patients met inclusion criteria (n = 54 anti-TNF therapy, n = 15 received no biologic therapy). There were no differences between the anti-TNF and no biologic cohorts with respect to demographics or CD characteristics. No significant differences in overall 30-day postoperative infectious complications existed between patients exposed to anti-TNF agents and those with no preoperative exposure, or in its subcategories of surgical infectious complications and non-surgical infectious complications. There was also no difference in the rate of ileus, readmission, or ROR. CONCLUSION(S): Preoperative exposure to anti-TNF biologic therapy does not add to overall or infectious 30-day postoperative morbidity in pediatric CD patients.

Abstract Background The decision to either escalate medical therapy or proceed to ileocecal resection (ICR) in patients with terminal ileal Crohn disease (CD) remains largely subjective. We sought to develop a risk score for predicting ICR at 1 year from computed tomography or magnetic resonance enterography (CTE/MRE). Methods We conducted a retrospective cohort study including all consecutive adult (> 18 years) patients with imaging findings of terminal ileal CD (Montreal classification: B1, inflammatory predominant; B2, stricturing; or B3, penetrating) on CTE/MRE between January 1, 2016, and December 31, 2016. The risk for ICR at 6 months and at 1 year of CTE/MRE and risk factors associated with ICR, including demographics, CD-specific immunosuppressive therapeutics, and disease presentation at the time of imaging, were determined. Results Of 559 patients, 121 (21.6%) underwent ICR during follow-up (1.4 years [IQR 0.21–1.64 years]); the risk for ICR at 6 months and at 1 year was 18.2% (95% CI 14.7%–21.6%) and 20.5% (95% CI 16.8%–24.1%), respectively. Multivariable analysis revealed Montreal classification (B2, hazard ratio [HR] 2.73, and B3, HR 6.80, both P < 0.0001), upstream bowel dilation (HR 3.06, P < 0.0001), and younger age (19–29 years reference, 30–44 years, HR 0.83 [P = 0.40]; 45–59 years, HR 0.58 [P = 0.04], and 60+ years, HR 0.45 [P = 0.01]) to significantly increase the likelihood of ICR. A predictive nomogram for interval ICR was developed based on these significant variables. Conclusions The presence of CD strictures, penetrating complications, and upstream bowel dilation on CTE/MRE, combined with young age, significantly predict ICR. The suggested risk model may facilitate objective therapeutic decision-making.