RESUMEN
INTRODUCTION: Rigid proctosigmoidoscopy (RP) and flexible sigmoidoscopy (FS) are two modalities commonly used for intraoperative evaluation of colorectal anastomoses. This study seeks to determine whether there is an association between the endoscopic modality used to evaluate colorectal anastomoses and the rate of anastomotic leak (AL), organ space infection, and overall infectious complication. METHODS: The 2012-2018 American College of Surgeons National Surgical Quality Improvement Program database was queried for patients undergoing colorectal anastomoses. Anastomotic evaluation method (RP versus FS) was identified by Current Procedural Terminologycoding and used for group classification. Outcomes measured included AL, organ space infections, and overall infection. Multivariable logistic regression analysis for predicting AL was performed. RESULTS: We identified 7100 patients who underwent a colorectal anastomosis with intraoperative endoscopic evaluation. RP was utilized in 3397 (47.8%) and FS in 3703 (52.2%) patients. RP was used more commonly in diverticulitis (44.5% versus 36.2%, P < 0.01), while FS was used more frequently in malignancy (47.5% versus 36.7%, P < 0.01). Anastomotic evaluation with FS was associated with lower rates of organ space infection (3.8% versus 4.8%, P = 0.025) and AL (2.9% versus 3.8%, P = 0.028) compared to RP. On multivariate logistic regression modeling, anastomotic evaluation with RP was associated with a higher risk of AL (odds ratio 1.403, 95% CI 1.028-1.916, P = 0.033) compared to FS. CONCLUSIONS: Compared to FS, rigid proctosigmoidoscopic evaluation of a colorectal anastomosis was associated with an increased rate of AL and organ space infection.
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Neoplasias Colorrectales , Proctoscopía , Humanos , Proctoscopía/efectos adversos , Anastomosis Quirúrgica/efectos adversos , Anastomosis Quirúrgica/métodos , Fuga Anastomótica/diagnóstico , Fuga Anastomótica/epidemiología , Fuga Anastomótica/etiología , Recto/cirugía , Recto/patología , Neoplasias Colorrectales/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND: While others have reported severe acute respiratory syndrome-related coronavirus 2(SARS-CoV-2) seroprevalence studies in health care workers (HCWs), we leverage the use of a highly sensitive coronavirus antigen microarray to identify a group of seropositive health care workers who were missed by daily symptom screening that was instituted prior to any epidemiologically significant local outbreak. Given that most health care facilities rely on daily symptom screening as the primary method to identify SARS-CoV-2 among health care workers, here, we aim to determine how demographic, occupational, and clinical variables influence SARS-CoV-2 seropositivity among health care workers. METHODS: We designed a cross-sectional survey of HCWs for SARS-CoV-2 seropositivity conducted from May 15th to June 30th 2020 at a 418-bed academic hospital in Orange County, California. From an eligible population of 5,349 HCWs, study participants were recruited in two ways: an open cohort, and a targeted cohort. The open cohort was open to anyone, whereas the targeted cohort that recruited HCWs previously screened for COVID-19 or work in high-risk units. A total of 1,557 HCWs completed the survey and provided specimens, including 1,044 in the open cohort and 513 in the targeted cohort. Demographic, occupational, and clinical variables were surveyed electronically. SARS-CoV-2 seropositivity was assessed using a coronavirus antigen microarray (CoVAM), which measures antibodies against eleven viral antigens to identify prior infection with 98% specificity and 93% sensitivity. RESULTS: Among tested HCWs (n = 1,557), SARS-CoV-2 seropositivity was 10.8%, and risk factors included male gender (OR 1.48, 95% CI 1.05-2.06), exposure to COVID-19 outside of work (2.29, 1.14-4.29), working in food or environmental services (4.85, 1.51-14.85), and working in COVID-19 units (ICU: 2.28, 1.29-3.96; ward: 1.59, 1.01-2.48). Amongst 1,103 HCWs not previously screened, seropositivity was 8.0%, and additional risk factors included younger age (1.57, 1.00-2.45) and working in administration (2.69, 1.10-7.10). CONCLUSION: SARS-CoV-2 seropositivity is significantly higher than reported case counts even among HCWs who are meticulously screened. Seropositive HCWs missed by screening were more likely to be younger, work outside direct patient care, or have exposure outside of work.
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COVID-19 , SARS-CoV-2 , Humanos , Masculino , COVID-19/epidemiología , Estudios Transversales , Pandemias , Estudios Seroepidemiológicos , Personal de Salud , Anticuerpos AntiviralesRESUMEN
BACKGROUND: Indocyanine green fluoroscopy has been shown to improve anastomotic leak rates in early phase trials. OBJECTIVE: We hypothesized that the use of fluoroscopy to ensure anastomotic perfusion may decrease anastomotic leak after low anterior resection. DESIGN: We performed a 1:1 randomized controlled parallel study. Recruitment of 450 to 1000 patients was planned over 2 years. SETTINGS: This was a multicenter trial. PATIENTS: Included patients were those undergoing resection defined as anastomosis within 10 cm of the anal verge. INTERVENTION: Patients underwent standard evaluation of tissue perfusion versus standard in conjunction with perfusion evaluation using indocyanine green fluoroscopy. MAIN OUTCOME MEASURES: Primary outcome was anastomotic leak, with secondary outcomes of perfusion assessment and the rate of postoperative abscess requiring intervention. RESULTS: This study was concluded early because of decreasing accrual rates. A total of 25 centers recruited 347 patients, of whom 178 were randomly assigned to perfusion and 169 to standard. The groups had comparable tumor-specific and patient-specific demographics. Neoadjuvant chemoradiation was performed in 63.5% of perfusion and 65.7% of standard (p > 0.05). Mean level of anastomosis was 5.2 ± 3.1 cm in perfusion compared with 5.2 ± 3.3 cm in standard (p > 0.05). Sufficient visualization of perfusion was reported in 95.4% of patients in the perfusion group. Postoperative abscess requiring surgical management was reported in 5.7% of perfusion and 4.2% of standard (p = 0.75). Anastomotic leak was reported in 9.0% of perfusion compared with 9.6% of standard (p = 0.37). On multivariate regression analysis, there was no difference in anastomotic leak rates between perfusion and standard (OR = 0.845 (95% CI, 0.375-1.905); p = 0.34). LIMITATIONS: The predetermined sample size to adequately reduce the risk of type II error was not achieved. CONCLUSIONS: Successful visualization of perfusion can be achieved with indocyanine green fluoroscopy. However, no difference in anastomotic leak rates was observed between patients who underwent perfusion assessment versus standard surgical technique. In experienced hands, the addition of routine indocyanine green fluoroscopy to standard practice adds no evident clinical benefit. See Video Abstract at http://links.lww.com/DCR/B560. VALORACIN DE LA IRRIGACIN DE LADO IZQUIERDO/RESECCIN ANTERIOR BAJA PILAR III UN ESTUDIO ALEATORIZADO, CONTROLADO, PARALELO Y MULTICNTRICO QUE EVALA LOS RESULTADOS DE LA IRRIGACIN CON PINPOINT IMGENES DE FLUORESCENCIA CERCANA AL INFRARROJO EN LA RESECCIN ANTERIOR BAJA: ANTECEDENTES:Se ha demostrado que la fluoroscopia con verde de indocianina mejora las tasas de fuga anastomótica en ensayos en fases iniciales.OBJETIVO:Nuestra hipótesis es que la utilización de fluoroscopia para asegurar la irrigación anastomótica puede disminuir la fuga anastomótica luego de una resección anterior baja.DISEÑO:Realizamos un estudio paralelo, controlado, aleatorizado 1:1. Se planificó el reclutamiento de 450-1000 pacientes durante 2 años.AMBITO:Multicéntrico.PACIENTES:Pacientes sometidos a resección definida como una anastomosis dentro de los 10cm del margen anal.INTERVENCIÓN:Pacientes que se sometieron a la evaluación estándar de la irrigación tisular contra la estándar en conjunto con la valoración de la irrigación mediante fluoroscopia con verde indocianina.PRINCIPALES VARIABLES EVALUADAS:El principal resultado fue la fuga anastomótica, y los resultados secundarios fueron la evaluación de la perfusión y la tasa de absceso posoperatorio que requirió intervención.RESULTADOS:Este estudio se cerró anticipadamente debido a la disminución de las tasas de acumulación. Un total de 25 centros reclutaron a 347 pacientes, de los cuales 178 fueron, de manera aleatoria, asignados a perfusión y 169 a estándar. Los grupos tenían datos demográficos específicos del tumor y del paciente similares. Recibieron quimio-radioterapia neoadyuvante el 63,5% de la perfusión y el 65,7% del estándar (p> 0,05). La anastomosis estuvo en un nivel promedio de 5,2 + 3,1 cm en perfusión en comparación con 5,2 + 3,3 cm en estándar (p> 0,05). Se reportó una visualización suficiente de la perfusión en el 95,4% de los pacientes del grupo de perfusión. El absceso posoperatorio que requirió tratamiento quirúrgico fue de 5,7% de los perfusion y en el 4,2% del estándar (p = 0,75). Se informó fuga anastomótica en el 9,0% de la perfusión en comparación con el 9,6% del estándar (p = 0,37). En el análisis de regresión multivariante, no hubo diferencias en las tasas de fuga anastomótica entre la perfusión y el estándar (OR 0,845; IC del 95% (0,375; 1,905); p = 0,34).LIMITACIONES:No se logró el tamaño de muestra predeterminado para reducir satisfactoriamente el riesgo de error tipo II.CONCLUSIÓN:Se puede obtener una visualización adecuada de la perfusión con ICG-F. Sin embargo, no se observaron diferencias en las tasas de fuga anastomótica entre los pacientes que se sometieron a evaluación de la perfusión versus la técnica quirúrgica estándar. En manos expertas, agregar ICG-F a la rutina de la práctica estándar no agrega ningún beneficio clínico evidente. Consulte Video Resumen en http://links.lww.com/DCR/B560. (Traducción-Dr Juan Antonio Villanueva-Herrero).
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Fuga Anastomótica/prevención & control , Colon/irrigación sanguínea , Imagen Óptica , Neoplasias del Recto/cirugía , Recto/irrigación sanguínea , Anastomosis Quirúrgica , Fuga Anastomótica/etiología , Colon/diagnóstico por imagen , Femenino , Fluoroscopía , Humanos , Verde de Indocianina , Cuidados Intraoperatorios , Masculino , Persona de Mediana Edad , Recto/diagnóstico por imagenRESUMEN
BACKGROUND: We speculated that a laparoscopic approach to emergent/urgent partial colectomy for colonic obstruction would be associated with less morbidity and shorter length of stay with similar mortality to open colectomy. We compared the outcomes of laparoscopic and open approaches to emergent/urgent partial colectomy for colonic obstruction from colonic cancer using data from the National Surgical Quality Improvement Program (NSQIP) database for the period of 2012-2017. METHODS: Multivariate analysis compared NSQIP data points following laparoscopic, laparoscopic converted to open, and open colectomy for emergent/urgent colectomy for colonic obstruction from colon cancer from 2012 to 2017. RESULTS: A total of 1293 patients who underwent emergent colectomy for colon obstruction from colon cancer during 2012-2017 were identified within the NSQIP database. Laparoscopic approach was used for colonic obstruction in 19.3% of operations with a conversion rate of 28.5%. A laparoscopic approach to obstructing colonic cancers was associated with lower morbidity (50% vs. 61.8%, AOR: 0.67, P = 0.01) and shorter hospitalization length (10 days vs. 13 days, mean difference: 3 days, P < 0.01) compared with an open approach. However, the mean operation duration was longer in laparoscopic operations than open operations (159 min vs. 137 min, P < 0.01). CONCLUSION: A laparoscopic approach to malignant colonic obstruction is associated with decreased morbidity. This suggests that efforts should be directed towards increasing the utilization of laparoscopic approaches for the surgical treatment of colonic obstruction.
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Neoplasias del Colon , Laparoscopía , Colectomía , Neoplasias del Colon/complicaciones , Neoplasias del Colon/cirugía , Humanos , Tiempo de Internación , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Abnormally high estimated glomerular filtration rates (eGFRs) are associated with endothelial dysfunction and frailty. Previous studies have shown that low eGFR is associated with increased morbidity, but few reports address high eGFR. The purpose of this study is to evaluate the association of high eGFR with surgical outcomes in patients undergoing surgery for gastrointestinal malignancies. METHODS: We identified patients who underwent elective surgery for gastrointestinal malignancies from 2005 to 2015 in the American College of Surgeons National Surgical Quality Improvement Program database. We evaluated associations of eGFR with surgical outcomes by Cox or logistic models with restricted cubic spline functions, adjusting for case mix variables (i.e. age, gender, race and diabetes). RESULTS: The median eGFR is 83 (interquartile range 67-96) mL/min/1.73 m2. Thirty-day mortality was 1.9% (2555/136 896). There is a U-shaped relationship between eGFR and 30-day mortality. The adjusted hazard ratios (95% confidence intervals) for eGFRs of 30, 60, 105 and 120 mL/min/1.73 m2 (versus 90 mL/min/1.73 m2) are 1.73 (1.52-1.97), 1.00 (0.89-1.11), 1.42 (1.31-1.55) and 2.20 (1.79-2.70), respectively. Similar associations are shown for other surgical outcomes, including return to the operating room and postoperative pneumonia. Subgroup analyses show that eGFRs both higher and lower than the respective medians are consistently associated with a higher risk of adverse outcomes across age, gender and race. CONCLUSIONS: High and low eGFRs are associated with more adverse surgical outcomes in patients undergoing surgery for gastrointestinal malignancies. The eGFR associated with the lowest postoperative risk is approximately at the median eGFR of a given population.
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Procedimientos Quirúrgicos del Sistema Digestivo , Neoplasias Gastrointestinales/cirugía , Tasa de Filtración Glomerular/fisiología , Complicaciones Posoperatorias/epidemiología , Anciano , Femenino , Neoplasias Gastrointestinales/fisiopatología , Humanos , Masculino , Morbilidad/tendencias , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Factores de Riesgo , Tasa de Supervivencia/tendencias , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Laparoscopic ileostomy closure with intracorporeal anastomosis offers potential advantages over open reversal with extracorporeal anastomosis, including earlier return of bowel function and reduced postoperative pain. In this study, we aim to compare the outcome and cost of laparoscopic ileostomy reversal (utilizing either intracorporeal or extracorporeal anastomosis) with open ileostomy reversal. METHODS: A retrospective review of sequential patients undergoing elective loop ileostomy reversal between 2013 and 2016 at a single, high-volume institution was performed. Patients were stratified on the basis of operative approach: open reversal, laparoscopic-assisted reversal with extracorporeal anastomosis (LE), and laparoscopic reversal with intracorporeal anastomosis (LI). Linear and logistic regressions were utilized to perform multivariate analysis and determine risk-adjusted outcomes. RESULTS: Of 132 sequential cases of loop ileostomy reversal, 50 (38%) underwent open, 49 (37%) underwent LE, and 33 (22%) underwent LI. Demographic data and preoperative comorbidities were similar between the three cohorts. Median length of stay was significantly shorter for LI (52.1 h, p < 0.05) compared to open (69.0 h) and LE (69.6 h). After risk-adjusted analysis, length of stay was significant shorter in LI compared to LE (GM 0.78, 95% CI 0.64-0.93, p < 0.01) and open reversal (GM 0.78, 95% CI 0.66-0.93, p < 0.01). Risk-adjusted 30-day morbidity rates were similar for LI compared to LE (OR 0.43, 95% CI 0.081-2.33, p = 0.33) and open reversal (OR 0.53, 95% CI 0.09-3.125, p = 0.48). Median in-hospital direct cost was similar for LI ($6575.00), LE ($6722.50), and open reversal ($6181.00). CONCLUSION: Laparoscopic ileostomy reversal with intracorporeal anastomosis was associated with shorter length of stay without increased overall direct cost. The technique of laparoscopic ileostomy reversal warrants continued study in a randomized clinical trial.
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Anastomosis Quirúrgica/métodos , Ileostomía , Laparoscopía , Anciano , Costos y Análisis de Costo , Femenino , Humanos , Ileostomía/efectos adversos , Ileostomía/métodos , Intestino Delgado/cirugía , Laparoscopía/economía , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Estudios RetrospectivosRESUMEN
BACKGROUND: Laparoscopic sleeve gastrectomy has become the procedure of choice for the treatment of morbid obesity. Robotic sleeve gastrectomy is an alternative surgical option, but its utilization has been low. The aim of this study was to evaluate the contemporary outcomes of robotic sleeve gastrectomy (RSG) versus laparoscopic sleeve gastrectomy (LSG) using a national database from accredited bariatric centers. STUDY DESIGN: Using the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database, clinical data for patients who underwent RSG or LSG were examined. Emergent and revisional cases were excluded. A multivariate logistic regression model was utilized to compare the outcomes between RSG and LSG. RESULTS: A total of 75,079 patients underwent sleeve gastrectomy with 70,298 (93.6%) LSG and 4781 (6.4%) RSG. Preoperative sleep apnea and hypoalbumenia were significantly higher in the RSG group (P < 0.01). Mean length of stay was similar between RSG and LSG (1.8 ± 2.0 vs. 1.7 ± 2.0 days, P = 0.17). Operative time was longer in the RSG group (102 ± 43 vs. 74 ± 36 min, P < 0.01). There was no significant difference in 30-day mortality between the RSG versus LSG group (0.02% vs. 0.01%, AOR 0.85; 95% CI 0.11-6.46, P = 0.88). However, RSG was associated with higher serious morbidity (1.1% vs. 0.8%, AOR 1.40; 95% CI 1.05-1.86, P < 0.01), higher leak rate (1.5% vs. 0.5%, AOR 3.14; 95% CI 2.65-4.42, P < 0.01), and higher surgical site infection rate (0.7% vs. 0.4%, AOR 1.55; 95% CI 1.08-2.23, P = 0.01). CONCLUSIONS: Robotic sleeve gastrectomy has longer operative time and is associated with higher postoperative morbidity including leak and surgical site infections. Laparoscopy should continue to be the surgical approach of choice for sleeve gastrectomy.
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Cirugía Bariátrica/métodos , Gastrectomía/métodos , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Adulto , Cirugía Bariátrica/efectos adversos , Cirugía Bariátrica/mortalidad , Bases de Datos Factuales , Femenino , Gastrectomía/efectos adversos , Gastrectomía/mortalidad , Humanos , Laparoscopía/efectos adversos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Obesidad Mórbida/cirugía , Tempo Operativo , Mejoramiento de la Calidad , Procedimientos Quirúrgicos Robotizados/efectos adversos , Infección de la Herida Quirúrgica/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: Adding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response. OBJECTIVE: The purpose of this study was to analyze disease-free and overall survival. DESIGN: This was a nonrandomized phase II trial. SETTINGS: The study was conducted at multiple institutions. PATIENTS: Four sequential study groups with stage II or III rectal cancer were included. INTERVENTION: All of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6. MAIN OUTCOME MEASURES: The trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study. RESULTS: Of 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004, <0.001, and 0.001). A secondary analysis including only patients who received ≥1 cycle of FOLFOX still showed differences in survival between study groups (p = 0.03). LIMITATIONS: The trial was not randomized and was not powered to show differences in survival. Survival data were not available for 19% of the patients. CONCLUSIONS: Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias del Recto/tratamiento farmacológico , Neoplasias del Recto/radioterapia , Recto/patología , Anciano , Quimioradioterapia/métodos , Quimioterapia Adyuvante/métodos , Supervivencia sin Enfermedad , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/uso terapéutico , Estudios de Seguimiento , Humanos , Infusiones Intravenosas , Leucovorina/administración & dosificación , Leucovorina/uso terapéutico , Masculino , Persona de Mediana Edad , Invasividad Neoplásica/patología , Estadificación de Neoplasias , Ensayos Clínicos Controlados no Aleatorios como Asunto/métodos , Compuestos Organoplatinos/administración & dosificación , Compuestos Organoplatinos/uso terapéutico , Oxaliplatino , Neoplasias del Recto/cirugía , Recto/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Anastomotic leak is a devastating postoperative complication following rectal anastomoses associated with significant clinical and oncological implications. As a result, there is a need for novel intraoperative methods that will help predict anastomotic leak. METHODS: From 2011 to 2014, patient undergoing rectal anastomoses by colorectal surgeons at our institution underwent prospective application of intraoperative flexible endoscopy with mucosal grading. Retrospective review of patient medical records was performed. After creation of the colorectal anastomosis, application of a three-tier endoscopic mucosal grading system occurred. Grade 1 was defined as circumferentially normal appearing peri-anastomotic mucosa. Grade 2 was defined as ischemia or congestion involving <30% of either the colon or rectal mucosa. Grade 3 was defined as ischemia or congestion involving >30% of the colon or rectal mucosa or ischemia/congestion involving both sides of the staple line. RESULTS: From 2011 to 2014, a total of 106 patients were reviewed. Grade 1 anastomoses were created in 92 (86.7%) patients and Grade 2 anastomoses were created in 10 (9.4%) patients. All 4 (3.8%) Grade 3 patients underwent immediate intraoperative anastomosis takedown and re-creation, with subsequent re-classification as Grade 1. Demographic and comorbidity data were similar between Grade 1 and Grade 2 patients. Anastomotic leak rate for the entire cohort was 12.2%. Grade 1 patients demonstrated a leak rate of 9.4% (9/96) and Grade 2 patients demonstrated a leak rate of 40% (4/10). Multivariate logistic regression associated Grade 2 classification with an increased risk of anastomotic leak (OR 4.09, 95% CI 1.21-13.63, P = 0.023). CONCLUSION: Endoscopic mucosal grading is a feasible intraoperative technique that has a role following creation of a rectal anastomosis. Identification of a Grade 2 or Grade 3 anastomosis should provoke strong consideration for immediate intraoperative revision.
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Anastomosis Quirúrgica , Fuga Anastomótica/patología , Complicaciones Posoperatorias/patología , Recto/cirugía , Adulto , Anciano , Anastomosis Quirúrgica/métodos , Fuga Anastomótica/etiología , Endoscopía/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Recto/patología , Estudios Retrospectivos , Grapado Quirúrgico/métodosRESUMEN
BACKGROUND: Patients with severe chronic obstructive pulmonary disease (COPD) are at a higher risk for postoperative respiratory complications. Despite the benefits of a minimally invasive approach, laparoscopic pneumoperitoneum can substantially reduce functional residual capacity and raise alveolar dead space, potentially increasing the risk of respiratory failure which may be poorly tolerated by COPD patients. This raises controversy as to whether open techniques should be preferentially employed in this population. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database from 2011 to 2014 was used to examine the clinical data from patients with COPD who electively underwent laparoscopic and open colectomy. Patients defined as having COPD demonstrated either functional disability, chronic use of bronchodilators, prior COPD-related hospitalization, or reduced forced expiratory reserve volumes on lung testing (FEV1 <75%). Demographic data and preoperative characteristics were compared. Linear and logistic regressions were utilized to perform multivariate analysis and determine risk-adjusted outcomes. RESULTS: Of the 4397 patients with COPD, 53.8% underwent laparoscopic colectomy (LC) while 46.2% underwent open colectomy (OC). The LC and OC groups were similar with respect to demographic data and preoperative comorbidities. Equivalent frequencies of exertional dyspnea (LC 35.4 vs OC 37.7%, P = 0.11) were noted. After multivariate risk adjustment, OC demonstrated an increased rate of overall respiratory complications including pneumonia, reintubation, and prolonged ventilator dependency when compared to LC (OR 1.60, 95% CI 1.30-1.98, P < 0.01). OC was associated with longer length of stay (10 ± 8 vs. 6.7 ± 7 days, P < 0.01) and higher readmission (OR 1.36, 95% CI 1.09-1.68, P < 0.01) compared to LC. CONCLUSION: Despite the potential risks of laparoscopic pneumoperitoneum in the susceptible COPD population, a minimally invasive approach was associated with lower risk of postoperative respiratory complications, shorter length of stay, and decrease in postoperative morbidity.
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Colectomía/métodos , Laparoscopía/efectos adversos , Neumonía/etiología , Neumoperitoneo Artificial/efectos adversos , Complicaciones Posoperatorias/etiología , Enfermedad Pulmonar Obstructiva Crónica/cirugía , Insuficiencia Respiratoria/etiología , Anciano , Bases de Datos Factuales , Procedimientos Quirúrgicos Electivos/efectos adversos , Procedimientos Quirúrgicos Electivos/métodos , Femenino , Humanos , Laparoscopía/métodos , Modelos Lineales , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Neumonía/epidemiología , Neumonía/prevención & control , Neumoperitoneo Artificial/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Insuficiencia Respiratoria/epidemiología , Insuficiencia Respiratoria/prevención & control , Estudios Retrospectivos , Ajuste de Riesgo , Factores de Riesgo , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: National examination of open proctectomy (OP), laparoscopic proctectomy (LP), and robotic proctectomy (RP) in pathological outcomes and overall survival (OS). BACKGROUND: Surgical management for rectal adenocarcinoma is evolving towards utilization of LP and RP. However, the oncological impacts of a minimally invasive approach to rectal cancer have yet to be defined. METHODS: Retrospective review of the National Cancer Database identified patients with nonmetastatic locally advanced rectal adenocarcinoma from 2010 to 2014, who underwent neoadjuvant chemoradiation, surgical resection, and adjuvant therapy. Cases were stratified by surgical approach. Multivariate analysis was used to compare pathological outcomes. Cox proportional-hazard modeling and Kaplan-Meier analyses were used to estimate long-term OS. RESULTS: Of 6313 cases identified, 53.8% underwent OP, 31.8% underwent LP, and 14.3% underwent RP. Higher-volume academic/research and comprehensive community centers combined to perform 80% of laparoscopic cases and 83% of robotic cases. In an intent-to-treat model, multivariate analysis demonstrated superior circumferential margin negativity rates with LP compared with OP (odds ratio 1.34, 95% confidence interval 1.02-1.77, P = 0.036). Cox proportional-hazard modeling demonstrated a lower death hazard ratio for LP compared with OP (hazard ratio 0.81, 95% confidence interval 0.67-0.99, P = 0.037). Kaplan-Meier analysis demonstrated a 5-year OS of 81% in LP compared with 78% in RP and 76% in OP (P = 0.0198). CONCLUSION: In the hands of experienced colorectal specialists treating selected patients, LP may be a valuable operative technique that is associated with oncological benefits. Further exploration of pathological outcomes and long-term survival by means of prospective randomized trials may offer more definitive conclusions regarding comparisons of open and minimally invasive technique.
Asunto(s)
Adenocarcinoma/cirugía , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Laparoscopía/métodos , Neoplasias del Recto/cirugía , Recto/cirugía , Robótica , Adenocarcinoma/mortalidad , Adenocarcinoma/patología , Quimioradioterapia Adyuvante , Quimioterapia Adyuvante , Femenino , Humanos , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Neoplasias del Recto/mortalidad , Neoplasias del Recto/patología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Motor peripheral nerve injury is a rare but serious event after colorectal surgery, and a nationwide study of this complication is lacking. OBJECTIVE: The purpose of this study was to report the incidence, trends, and risk factors of motor peripheral nerve injury during colorectal surgery. DESIGN: The National Surgical Quality Improvement Program database was surveyed for motor peripheral nerve injury complicating colorectal procedures. Risk factors for this complication were identified using logistic regression analysis. SETTINGS: The study used a national database. PATIENTS: Patients undergoing colorectal resection between 2005 and 2013 were included. MAIN OUTCOME MEASURES: The incidence, trends, and risk factors for motor peripheral nerve injury complicating colorectal procedures were measured. RESULTS: We identified 186,936 colorectal cases, of which 50,470 (27%) were performed laparoscopically. Motor peripheral nerve injury occurred in 122 patients (0.065%). Injury rates declined over the study period, from 0.025% in 2006 to <0.010% in 2013 (p < 0.001). Patients with motor peripheral nerve injury were younger (mean ± SD; 54.02 ± 15.41 y vs 61.56 ± 15.95 y; p < 0.001), more likely to be obese (BMI ≥30; 43% vs 31%; p = 0.003), and more likely to have received radiotherapy (12.3% vs 4.7%; p < 0.001). Nerve injury was also associated with longer operative times (277.16 ± 169.79 min vs 176.69 ± 104.80 min; p < 0.001) and was less likely to be associated with laparoscopy (p = 0.043). Multivariate analysis revealed that increasing operative time was associated with nerve injury (OR = 1.04 (95% CI, 1.03-1.04)), whereas increasing age was associated with a protective effect (OR = 0.80 (95% CI, 0.71-0.90)). LIMITATIONS: This study was limited by its retrospective nature. CONCLUSIONS: Motor peripheral nerve injury during colorectal procedures is uncommon (0.065%), and its rate declined significantly over the study period. Prolonged operative time is the strongest predictor of motor peripheral nerve injury during colorectal procedures. Instituting and documenting measures to prevent nerve injury is imperative; however, special attention to this complication is necessary when surgeons contemplate long colorectal procedures.
Asunto(s)
Cirugía Colorrectal/efectos adversos , Traumatismos de los Nervios Periféricos/epidemiología , Traumatismos de los Nervios Periféricos/etiología , Mejoramiento de la Calidad , Adulto , Anciano , Estudios Transversales , Femenino , Humanos , Incidencia , Laparoscopía/efectos adversos , Masculino , Persona de Mediana Edad , Factores de RiesgoRESUMEN
Anastomotic leaks following colorectal anastomosis has substantial implications including increased morbidity, longer hospitalization, and reduced overall survival. The etiology of leaks includes patient factors, technical factors, and anastomotic perfusion. An intact anastomotic blood supply is especially crucial in the physiology of anastomotic healing. To date, no established intraoperative methods have been developed that reliably and reproducibly identify and prevent leak occurrence. Recently, fluorescent angiography (FA) with indocyanine green (ICG) has emerged as an innovative modality for intraoperative perfusion assessment. ICG-FA can be performed before or after intestinal resection or, alternatively, after creation of the anastomosis. Angiographic assessment with near-infrared camera filters allows determination of perfusion adequacy, guiding additional intestinal resection and anastomotic revision. Early clinical experiences with ICG-FA demonstrated safety and feasibility. Large, multi-center prospective trials, such as the Perfusion Assessment in Laparoscopic Left-Sided/Anterior Resection Study (PILLAR II), demonstrated ease of use with remarkably low anastomotic leak rates after ICG-FA-guided intraoperative revision. Current randomized control trials featuring utilization in ICG-FA in low anterior resection are currently underway and will further clarify the role of ICG-FA in leak identification and prevention. Apart from colorectal surgery, FA has also been successfully employed in other surgical disciplines such as plastic surgery, vascular surgery, foregut surgery, urology, and gynecology.
Asunto(s)
Fuga Anastomótica/diagnóstico por imagen , Fuga Anastomótica/cirugía , Angiografía con Fluoresceína , Cirugía Asistida por Computador/métodos , Colon/cirugía , Colorantes Fluorescentes/uso terapéutico , Humanos , Verde de Indocianina/uso terapéutico , Estudios Prospectivos , Recto/cirugíaRESUMEN
OBJECTIVE: Postoperative ischemic colitis (IC) can be a serious complication following infrarenal abdominal aortic aneurysm (AAA) repair. We sought to identify risk factors and outcomes in patients developing IC after open AAA repair and endovascular aneurysm repair (EVAR). METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was used to examine clinical data of patients undergoing AAA repair from 2011 to 2012 who developed postoperative IC. Multivariate regression analysis was performed to identify risk factors and outcomes. RESULTS: We evaluated a cohort of 3486 patients who underwent AAA repair (11.6% open repair and 88.4% EVAR). The incidence of postoperative IC was 2.2% (5.2% for open repair and 1.8% for EVAR). Surgical treatment was needed in 49.3% of patients who developed IC. The mortality of patients with IC was higher than that of patients without IC (adjusted odds ratio [AOR], 4.23; 95% confidence interval [CI], 2.26-7.92; P < .01). The need for surgical treatment (AOR, 7.77; 95% CI, 2.08-28.98; P < .01) and age (AOR, 1.11; 95% CI, 1.01-1.22; P = .01) were mortality predictors of IC patients. Predictive factors of IC included need for intraoperative or postoperative transfusion (AOR, 6; 95% CI, 3.08-11.72; P < .01), rupture of the aneurysm before surgery (AOR, 4.07; 95% CI, 1.78-9.31; P < .01), renal failure requiring dialysis (AOR, 3.86; 95% CI, 1.18-12.62; P = .02), proximal extension of the aneurysm (AOR, 2.19; 95% CI, 1.04-4.59; P = .03), diabetes (AOR, 1.87; 95% CI, 1.01-3.46; P = .04), and female gender (AOR, 1.75; 95% CI, 1.01-3.02; P = .04). Although open AAA repair had three times higher rate of postoperative IC compared with endovascular repair, in multivariate analysis we did not find any statistically significant difference between open repair and EVAR in the development of IC (5.2% vs 1.8%; AOR, 1.25; 95% CI, 0.70-2.25; P = .43). CONCLUSIONS: Postoperative IC has a rate of 2.2% after AAA repair. However, it is associated with 38.7% mortality rate. Rupture of the aneurysm before surgery, need for transfusion, proximal extension of the aneurysm, renal failure requiring dialysis, diabetes, and female gender were significant predictors of postoperative IC. AAA patients who develop IC have four times higher mortality compared with those without IC. Surgical treatment is needed in nearly 50% of IC patients and is a predictor of higher mortality.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/cirugía , Implantación de Prótesis Vascular/efectos adversos , Colitis Isquémica/etiología , Procedimientos Endovasculares/efectos adversos , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/diagnóstico , Rotura de la Aorta/mortalidad , Implantación de Prótesis Vascular/mortalidad , Colitis Isquémica/diagnóstico , Colitis Isquémica/mortalidad , Colitis Isquémica/cirugía , Comorbilidad , Bases de Datos Factuales , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Incidencia , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores Sexuales , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: The utilization of minimally invasive surgery is increasing in colorectal surgery. We sought to compare the outcomes of patients who underwent elective open, laparoscopic, and robotic total abdominal colectomy. METHODS: The NIS database was used to examine the clinical data of patients who underwent an elective total colectomy procedure during 2009-2012. Multivariate regression analysis was performed to compare the three surgical approaches. RESULTS: We sampled a total of 26,721 patients who underwent elective total colectomy. Of these, 16,780 (62.8 %) had an open operation, while 9934 (37.2 %) had a minimally invasive approach (9614 laparoscopic surgery, and 326 robotic surgery). The most common indication for an operation was ulcerative colitis (31 %). Patients who underwent open surgery had significantly higher mortality and morbidity compared to laparoscopic (AOR 2.48, 1.30, P < 0.01) and robotic approaches (AOR 1.04, 1.30, P < 0.01 and P = 0.04, respectively). There was no significant difference in mortality and morbidity between the laparoscopic and robotic approaches (AOR 0.96, 1.03, P = 0.10, P = 0.78). However, conversion rate of laparoscopic surgery to open was significantly higher than that of robotic approach (13.3 vs. 1.5 %, P < 0.01). Patients who underwent laparoscopic surgery had significantly lower total hospital charges compared to patients who underwent open surgery (mean difference = $21,489, P < 0.01). Also, total hospital charges for a robotic approach were significantly higher than for a laparoscopic approach (mean difference = $15,595, P < 0.01). CONCLUSION: Minimally invasive approaches to total colectomy are safe, with the advantage of lower mortality and morbidity compared to an open approach. Although there was no significant difference in the morbidity between minimally invasive approaches, robotic surgery had a significantly lower conversion rate compared to laparoscopic approach. Total hospital charges are significantly higher in robotic surgery compared to laparoscopic approach.
Asunto(s)
Colectomía/métodos , Enfermedades del Colon/cirugía , Laparoscopía/métodos , Laparotomía/métodos , Complicaciones Posoperatorias/epidemiología , Procedimientos Quirúrgicos Robotizados/métodos , Adulto , Anciano , Colectomía/economía , Colitis Ulcerosa/cirugía , Neoplasias Colorrectales/cirugía , Conversión a Cirugía Abierta , Enfermedad de Crohn/cirugía , Bases de Datos Factuales , Diverticulitis del Colon/cirugía , Diverticulosis del Colon/cirugía , Procedimientos Quirúrgicos Electivos/economía , Procedimientos Quirúrgicos Electivos/métodos , Femenino , Precios de Hospital , Humanos , Laparoscopía/economía , Laparotomía/economía , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/economía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Mortalidad , Análisis Multivariante , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/economía , Resultado del TratamientoRESUMEN
BACKGROUND: Prolonged ileus is one of the most common postoperative complications after colorectal surgery. We sought to investigate the predictors of prolonged ileus following elective colon resections procedures. METHODS: The national participant user files of NSQIP databases were utilized to examine the clinical outcomes of patients undergoing elective colon resection during 2012-2013. Multivariate regression analysis was performed to investigate predictors of prolonged ileus. Prolonged ileus was defined as no return of bowel function in 7 days. RESULTS: We sampled a total of 27,560 patients who underwent colon resections; of these, 3497 (12.7%) patients had prolonged ileus. Patients with ileocolonic anastomosis (ICA) had a significantly higher rate of prolonged ileus compared to patients with colorectal anastomosis (CRA) (15 vs. 11.5%, AOR 1.25, P < 0.01). Prolonged ileus was significantly associated with intra-abdominal infections (13 vs. 2.8%, AOR 2.56, P < 0.01) and anastomotic leakage (12 vs. 2.4%, AOR 2.50, P < 0.01). Factors such as preoperative sepsis (AOR 1.63, P < 0.01), disseminated cancer (AOR 1.24, P = 0.01), and chronic obstructive pulmonary disease (AOR 1.27, P = 0.02) were associated with an increased risk of prolonged ileus, whereas oral antibiotic bowel preparation (AOR 0.77, P < 0.01) and laparoscopic surgery (AOR 0.51, P < 0.01) are associated with decreased prolonged ileus risk. CONCLUSIONS: Prolonged ileus is a common condition following colon resection, with an incidence of 12.7%. Among colon surgeries, colectomy with ICA resulted in the highest rate of postoperative prolonged ileus. Prolonged ileus is positively associated with anastomotic leak and intra-abdominal infections; thus, a high index of suspicion must be had in all patients with prolonged postoperative ileus.
Asunto(s)
Anastomosis Quirúrgica/métodos , Fuga Anastomótica/epidemiología , Antibacterianos/uso terapéutico , Colectomía/métodos , Neoplasias Colorrectales/cirugía , Ileus/epidemiología , Infecciones Intraabdominales/epidemiología , Complicaciones Posoperatorias/epidemiología , Factores de Edad , Anciano , Profilaxis Antibiótica , Colon/cirugía , Neoplasias Colorrectales/epidemiología , Bases de Datos Factuales , Procedimientos Quirúrgicos Electivos/métodos , Femenino , Humanos , Íleon/cirugía , Incidencia , Laparoscopía , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Modelos de Riesgos Proporcionales , Factores Protectores , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Recto/cirugía , Factores de Riesgo , Sepsis/epidemiología , Factores SexualesRESUMEN
BACKGROUND: The use of laparoscopy for right hemicolectomy has gained popularity allowing the option of a totally laparoscopic intracorporeal anastomosis (IA) for intestinal reconstruction. This technique may alleviate some of the technical limitations that a surgeon faces with a laparoscopic-assisted extracorporeal anastomosis (EA). METHODS: A retrospective chart review of 195 consecutive patients who underwent laparoscopic right hemicolectomy by four colorectal surgeons at three institutions from March 2005 to June 2014 was performed. Multivariate regression analysis was used to compare postoperative and oncologic outcomes. RESULTS: A total of 195 patients underwent laparoscopic right hemicolectomy over the study period, with 86 (44 %) patients receiving IA and 109 (56 %) patients receiving an EA. The most common indication for surgery in both groups was cancer: 56 (65 %) of IA cases and 57 (52 %) of EA cases. IA had a significantly higher rate of minor complications but no difference in serious complications compared to EA. Conversion to open resection was higher in EA. Using multivariate analysis to compare IA versus EA, there was no significant difference in length of stay, return of bowel function, risk of anastomotic leak, risk of intraabdominal abscess or risk of wound complications. Amongst cancer resections, there was no significant difference in the median number of lymph nodes harvested (18 LNs in IA group vs. 19 LNs in EA group, P > 0.05). There was also no significant difference in overall survival and disease-free survival at 5.7 years between the two groups. CONCLUSIONS: IA in laparoscopic right hemicolectomy is associated with similar postoperative and oncologic outcomes compared to EA. IA may possess advantages in terms of conversion and flexibility of specimen extraction, but this is counterbalanced by a higher incidence of minor complications. These findings suggest that IA represents a valid technique in the arsenal of the experienced colorectal surgeon without compromising outcomes.
Asunto(s)
Anastomosis Quirúrgica/métodos , Colectomía/métodos , Laparoscopía , Anciano , Neoplasias del Colon/cirugía , Conversión a Cirugía Abierta , Femenino , Humanos , Enfermedades Inflamatorias del Intestino/cirugía , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Colorectal cancer (CRC) incidence is rising among patients under age 50. As such, we set out to determine the proportion of CRC-related hospital admissions and distribution of colon cancer by stage in different age groups. METHODS: The NIS database for 2002-2012 was used to investigate trends of colorectal cancer resection by age, and the ACS NSQIP database for 2012-2013 was used to investigate contemporary stage at diagnosis for colon cancer in different age groups. RESULTS: A total of 1,198,421 patients were admitted to a hospital with a diagnosis of CRC and captured by the NIS database. Although the number of hospitalized CRC patients decreased from 2002 to 2012, the observed decrease was predominant in patients older than 65 years (P < 0.01) and in colon cancer compared to rectal cancer patients (P < 0.01). The proportion of patients younger than 65 years increased from 32.8 % in 2002 to 41.1 % in 2012, and the proportion of patients under age 50 increased from 9 to 12 %. In the NSQIP database, the age <50 group also had a significantly higher proportion of advanced disease (stage III/IV) compared to patients age 50 and older (62.3 vs. 47.5 %, P < 0.01). In 2012, it was observed that most patients with rectal cancer were younger than 65 years (55.8 %). CONCLUSION: There was a steady decrease in the number of hospitalized patients with colorectal cancer during the last decade, primarily attributable to a decrease in the older than 65 years age patients and colon cancer patients. The proportion of hospitalized patients age <50 is rising. In addition, patients younger than 50 years were more likely to have advanced disease compared to older patients.
Asunto(s)
Neoplasias Colorrectales/epidemiología , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Neoplasias Colorrectales/patología , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: There are limited data regarding the criteria for prophylactic treatment of venous thromboembolism (VTE) after hospital discharge. We sought to identify risk factors of post-hospital discharge VTE events following colorectal surgery. METHODS: The NSQIP database was utilized to examine patients developed VTE after hospital discharge following colorectal surgery during 2005-2013. Multivariate analysis using logistic regression was performed to quantify risk factors of VTE after discharge. RESULTS: We evaluated a total of 219,477 patients underwent colorectal resections. The overall incidence of VTE was 2.1 % (4556). 33.8 % (1541) of all VTE events occurred after hospital discharge. The length of postoperative hospitalization had a strong association with post-discharge VTE, with the highest risk in patients who were hospitalized for more than 1 week after operation (AOR 9.08, P < 0.01). Other factors associated with post-discharge VTE included chronic steroid use (AOR 1.81, P < 0.01), stage 4 colorectal cancer (AOR 1.40, P = 0.03), obesity (AOR 1.37, P < 0.01), age >70 (AOR 1.21, P = 0.04), and open surgery (AOR 1.36, P < 0.01). Patients who were hospitalized for more than 1 week after an open colorectal resections had a 12 times higher risk of post-discharge VTE event compared to patients hospitalized less than 4 days after a laparoscopic resection (AOR 12.34, P < 0.01). CONCLUSIONS: VTE is uncommon following colorectal resections; however, a significant proportion occurs after patients are discharged from the hospital (33.8 %). The length of postoperative hospitalization appears to have a strong association with post-discharge VTE. High-risk patients may benefit from continued VTE prophylaxis after discharge.
Asunto(s)
Colectomía/efectos adversos , Neoplasias Colorrectales/cirugía , Alta del Paciente , Complicaciones Posoperatorias/epidemiología , Tromboembolia Venosa/epidemiología , Anciano , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Patients with locally advanced rectal cancer who achieve a pathological complete response to neoadjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological complete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathological complete response. METHODS: We did a phase 2, non-randomised trial consisting of four sequential study groups of patients with stage II-III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradiation (fluorouracil 225 mg/m(2) per day by continuous infusion throughout radiotherapy, and 45·0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5·4 Gy). Patients in group 1 had total mesorectal excision 6-8 weeks after chemoradiation. Patients in groups 2-4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m(2) or 400 mg/m(2), according to the discretion of the treating investigator, oxaliplatin 85 mg/m(2) in a 2-h infusion, bolus fluorouracil 400 mg/m(2) on day 1, and a 46-h infusion of fluorouracil 2400 mg/m(2). The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00335816. FINDINGS: Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met criteria for analysis. 11 (18%, 95% CI 10-30) of 60 patients in group 1, 17 (25%, 16-37) of 67 in group 2, 20 (30%, 19-42) of 67 in group 3, and 25 (38%, 27-51) of 65 in group 4 achieved a pathological complete response (p=0·0036). Study group was independently associated with pathological complete response (group 4 compared with group 1 odds ratio 3·49, 95% CI 1·39-8·75; p=0·011). In group 2, two (3%) of 67 patients had grade 3 adverse events associated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neoadjuvant administration of mFOLFOX6 across groups 2-4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery-related complications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients). INTERPRETATION: Delivery of mFOLFOX6 after chemoradiation and before total mesorectal excision has the potential to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials. FUNDING: National Institutes of Health National Cancer Institute.