Are Biologics Safe in the Immediate Postoperative Period? A Single-Center Evaluation of Consecutive Crohn's Surgical Patients.

There is no study to date examining the safety of initiating or restarting biologic therapy after major abdominal surgery for Crohn's disease. 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. This was a retrospective cohort study. The study was conducted at an IBD referral center. 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. Ninety-day superficial surgical site infection, intra-abdominal sepsis, and overall postoperative infectious complications were measured. 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%. The study was limited by its retrospective design and single-center data. 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: 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.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.Estudio de cohorte retrospectivo.Centro de referencia de enfermedad inflamatoria intestinal.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.Infección superficial del sitio quirúrgico, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales a 90 días.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%.Diseño retrospectivo, y datos de un centro único.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)

Survival impact of adjuvant chemotherapy in patients with stage IIA colon cancer: Analysis of the National Cancer Database.

Utility of adjuvant chemotherapy for stage II cancer remains a matter of debate. Clinical guidelines suggest adjuvant chemotherapy for stage II tumors with high-risk features, in particular T4 tumors. However, limited consensus exists regarding the importance of other high-risk features (lymphovascular or perineural invasion, microsatellite instability). Our study aimed to investigate the impact of adjuvant chemotherapy for stage IIA (T3N0) colon cancer patients. Patients who underwent colectomy for stage IIA colon adenocarcinoma (2010-2015) were identified in the National Cancer Database (NCDB) and divided in two groups based on receipt of adjuvant chemotherapy vs observation. Inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier and Cox proportional hazards regression analyses were performed to compare overall survival between the two groups. Subgroup analysis of patients with specific high-risk features LVI, PNI and MSI was performed. Among 46 688 surgical patients with stage IIA colon adenocarcinoma 5937 (12.7%) received adjuvant chemotherapy, while 40 751 (87.3%) were observed. Five-year IPTW-adjusted survival was higher in the adjuvant chemotherapy group (79.7% [95% CI 79.1, 80.2]) compared to the observation group (70.3% [95% CI 69.7, 70.9]). Patients with high-risk pathological features showed an estimated 5-year survival benefit of 11.3% (78.2% [95% CI 77.4, 79.1] vs 66.9% [95% CI 65.9, 67.8]) when treated with adjuvant chemotherapy. This NCDB analysis revealed a survival benefit for patients with stage IIA colon adenocarcinoma and high-risk features that were treated with adjuvant chemotherapy

Clinically important body weight gain following total hip arthroplasty: a cohort study with 5-year follow-up

SummaryObjectiveLiterature examining the effects of total hip arthroplasty (THA) on subsequent body weight gain is inconclusive. Determining the extent to which clinically relevant weight gain occurs following THA has important public health implications.DesignWe used multi-variable logistic regression to compare data from one of the largest US-based THA registries to a population-based control sample from the same geographic region. We also identified factors that increased risk of clinically important weight gain specifically among persons undergoing THA. The outcome measure of interest was weight gain of ≥5% of body weight up to 5 years following surgery.ResultsThe multi-variable adjusted [age, sex, body mass index (BMI), education, comorbidity and pre-surgical weight change] odds ratio for important weight gain was 1.7 [95% confidence interval (CI), 1.06, 2.6] for a person with THA as compared to the control sample. Additional arthroplasty procedures during the 5-year follow-up further increased odds for important weight gain (OR = 2.0, 95% CI, 1.4, 2.7) relative to the control sample. A patient with THA had increased risk of important post-surgical weight gain of 12% (OR = 1.12, 95% CI, 1.08, 1.16) for every kilogram of pre-operative weight loss.ConclusionsWhile findings should be interpreted with caution because of missing follow-up weight data, patients with THA appear to be at increased risk of clinically important weight gain following surgery as compared to peers. Patients less than 60 years and who have lost a substantial amount of weight prior to surgery appear to be at particularly high risk of important post-surgical weight gain

Impact of enhanced recovery on oncological outcomes following minimally invasive surgery for rectal cancer.

Oncological outcomes of locally advanced rectal cancer depend on the quality of surgical and oncological management. Enhanced recovery pathways (ERPs) have yet to be assessed for their oncological impact when used in combination with minimally invasive surgery. This study assessed outcomes with or without an ERP in patients with rectal cancer. This was a retrospective analysis of all consecutive adult patients who underwent elective minimally invasive surgery for primary rectal adenocarcinoma with curative intent between February 2005 and April 2018. Both laparoscopic and robotic procedures were included. Short-term morbidity and overall survival were compared between patients treated according to the institutional ERP and those who received conventional care. A total of 600 patients underwent minimally invasive surgery, of whom 320 (53·3 per cent) were treated according to the ERP and 280 (46·7 per cent) received conventional care. ERP was associated with less overall morbidity (34·7 versus 54·3 per cent; P < 0·001). Patients in the ERP group had improved overall survival on univariable (91·4 versus 81·7 per cent at 5 years; hazard ratio (HR) 0·53, 95 per cent c.i. 0·28 to 0·99) but not multivariable (HR 0·78, 0·41 to 1·50) analysis. Multivariable analysis revealed age (HR 1·46, 1·17 to 1·82), male sex (HR 1·98, 1·05 to 3·70) and complications (HR 2·23, 1·30 to 3·83) as independent risk factors for compromised overall survival. Disease-free survival was comparable for patients who had ERP or conventional treatment (80·5 versus 84·6 per cent at 5 years respectively; P = 0·272). Treatment within an ERP was associated with a lower morbidity risk that may have had a subtle impact on overall but not disease-specific survival

Development and validation of a prediction score for safe outpatient colorectal resections.

Avoiding unnecessary inpatient stay may decrease hospital-acquired complications and costs while increasing patient satisfaction. This study aimed to develop and validate a score to identify patients eligible for safe same-day discharge after colorectal resections. This bi-institutional retrospective cohort study included consecutive patients undergoing elective colon and rectal resections (2011-2018) for benign and malignant indications. Two multivariable logistic models were developed based on demographic and surgical risk factors to predict a combined endpoint (ileus, anastomotic leak, intra-abdominal abscess, and readmission). Development and validation datasets were randomly sampled from the entire cohort. Areas under the receiver operating characteristic curves (AUC) were evaluated, and Hosmer-Lemeshow goodness-of-fit tests were used to assess validation model fit. Of 5,389 patients, 1,182 (21.9%) experienced at least one complication of the combined endpoint. Male gender, open surgery, ASA ≥3, wound class ≥3, ileostomy, surgical duration >3 hours, and perioperative IV fluids >3 L all had significantly greater odds of the combined endpoint in the parsimonious multivariable model (all P < .05). The reduced model considering only the 4 variables with the highest OR (>1.5) contained open surgery, ASA ≥3, wound class ≥3, and surgical duration ≥3 hours as predictors (all P < .05, AUC of 0.65; 95% CI 0.63, 0.68). Both the parsimonious model and the reduced model demonstrated no lack of fit in the validation cohort. The suggested score composed of preand intraoperative items may help physicians decide on patients' same-day discharge after colorectal resection

Impact of delay to surgery on survival in stage I-III colon cancer.

To assess the impact of delay from diagnosis to curative surgery on survival in patients with non-metastatic colon cancer. National Cancer database (NCDB) analysis (2004-2013) including all consecutive patients diagnosed with stage I-III colon cancer and treated with primary elective curative surgery. Short and long delays were defined as lower and upper quartiles of time from diagnosis to treatment, respectively. Age-, sex-, race-, tumor stage and location-, adjuvant treatment-, comorbidity- and socioeconomic factors-adjusted overall survival (OS) was compared between the two groups (short vs. long delay). A multivariable Cox regression model was used to identify the independent impact of each factor on OS. Time to treatment was <16 days in the short delay group (31,171 patients) and ≥37 days in the long delay group (29,617 patients). OS was 75.4 vs. 71.9% at 5 years and 56.6 vs. 49.7% at 10 years in short and long delay groups, respectively (both p < 0.0001). Besides demographic (comorbidities, advanced age) and pathological factors (transverse and right-vs. left-sided location, advanced tumor stage, poor differentiation, positive microscopic margins), treatment delay had a significant impact on OS (HR 1.06, 95% CI 1.05-1.07 per 14 day-delay) upon multivariable analysis. The adjusted hazard ratio for death increased continuously with delay times of longer than 30 days, to become significant after a delay of 40 days. This analysis using a national cancer database revealed a significant impact on OS when surgeries for resectable colon cancer were delayed beyond 40 days from time of diagnosis

Supplementary Material for: Factors Influencing Surveillance for Hepatocellular Carcinoma in Patients with Liver Cirrhosis

<p><b><i>Objective:</i></b> Hepatocellular carcinoma (HCC) is the second most common cause of cancer-related mortality worldwide, and a rising cause of cancer mortality in the U.S. Liver cirrhosis is the major risk factor for HCC. Surveillance of persons with cirrhosis facilitates early detection and improves outcomes. We assessed the surveillance rate for HCC within a major academic health system and identified factors influencing surveillance. <b><i>Patients and Methods:</i></b> We examined the surveillance rate for HCC using liver ultrasound, CT, or MRI, and factors influencing surveillance in a cohort of 369 Minnesota residents with cirrhosis seen at the Mayo Clinic between 2007 and 2009. <b><i>Results:</i></b> Ninety-three percent of cirrhosis patients received at least one surveillance study, but only 14% received the recommended uninterrupted semiannual surveillance. Thirty percent received ≥75% of recommended surveillance, and 59% received ≥50% of recommended surveillance. Factors increasing surveillance included gastroenterology or hepatology specialist visits (p < 0.0001), advanced liver disease as assessed by hepatic encephalopathy (p = 0.0008), and comorbid illness as assessed by diabetes mellitus (p = 0.02). Age, sex, race, residence, cirrhosis etiology, or number of primary care visits did not significantly affect the rate of surveillance. <b><i>Conclusions:</i></b> While the rate of surveillance in a major academic health system was higher than reported in other studies, surveillance was heavily dependent on visits to a subspecialist. This suggests a major and urgent national need to improve identification of individuals at risk for HCC in the primary care setting and the initiation and maintenance of surveillance by primary care practitioners.</p

Evaluating sex as a predictive marker for response to bevacizumab in metastatic colorectal carcinoma: Pooled analysis of 3,369 patients in the ARCAD database.

Previous studies suggest a possible sex-specific response to bevacizumab in metastatic colorectal carcinoma (mCRC), showing a benefit in males, while the effect in females is less significant. Data from 3369 patients with mCRC enrolled on four first-line randomised trials testing chemotherapy with or without bevacizumab (2000-2007) were pooled. Association between sex and progression-free survival and overall survival (OS) was evaluated by stratified Cox regression model, adjusted for potential confounders. Predictive value was evaluated by interaction effect between sex and treatment. In a pre-planned secondary analysis, analyses were stratified using an age cut point of 60 years to evaluate the possible role of menopausal-related effects. Bevacizumab was associated with an improved median OS in males and females, with a 2.3- and 0.6-months benefit, respectively. Stratified by age, bevacizumab resulted in improved OS in males at both age categories. In females at or above the age of 60 (n = 731), bevacizumab resulted in improved OS. However, in females below the age of 60 (n = 634), OS benefit did not reach statistical significance (adjusted hazard ratio = 0.94, 95% confidence interval 0.74-1.20). Our results confirmed the OS benefit from the addition of bevacizumab to first-line chemotherapy in mCRC in both sexes. Among females, the benefit was less than 1 month. For females under the age of 60, there was no survival benefit. These findings could be used to relieve financial toxicity or be redistributed within healthcare systems for other health-related purposes