Randomized Controlled Trial of Enhanced Recovery Program Dedicated to Elderly Patients After Colorectal Surgery.

BACKGROUND: Enhanced recovery program is a multimodal, multidisciplinary-team, evidence-based care approach to reduce perioperative surgical stress, decrease morbidity and hospital stay, and improve recovery after surgery. This program may be most beneficial for elderly (≥70 y), but sparse series have investigated this question. OBJECTIVE: Feasibility and efficiency of a dedicated enhanced recovery program in the elderly as compared with standard care were studied. DESIGN: This was a nonblinded, randomized controlled study. SETTINGS: This study was conducted in a single high-volume university hospital. PATIENTS: A total of 150 eligible elderly patients undergoing elective colorectal surgery were included. INTERVENTIONS: Enhanced recovery after colorectal elective surgery in elderly patients was studied. MAIN OUTCOME MEASURES: The primary outcome was 30-day postoperative morbidity. Additional outcomes included hospital stay, readmission, postoperative pain, opioid consumption, independence preservation, and protocol compliance. RESULTS: An enhanced recovery program reduces postoperative morbidity according to Clavien-Dindo classification by 47% as compared with standard care (35% vs 65%; p = 0.0003), total number of complications (54 vs 118; p = 0.0003), and infectious complications (13 vs 29; p = 0.001). No anastomotic leak was recorded in the enhanced recovery group versus 5 for the standard group (p = 0.01). The enhanced recovery program resulted in shorter hospital stay (7 vs 12 d; p = 0.003) and better independence preservation (home discharge, 87% vs 67%; p = 0.005). A high protocol compliance of 77.2% could be achieved in this population. According to multivariate analysis, enhanced recovery program was strongly associated with reduced morbidity (OR = 0.23 (95% CI, 0.09-0.57); p = 0.001), less severe complications (OR = 0.36 (95% CI, 0.15-0.84); p = 0.02), and shorter hospital stay (OR = 2.07 (95% CI, 1.33-3.22); p = 0.001). LIMITATIONS: Limitations were a single-center recruitment and the impossibility of subject or healthcare professional blinding attributed to the nature of this multimodal program. CONCLUSIONS: Enhanced recovery program is safe and improves postoperative recovery in elderly patients with decreased morbidity, shorter hospital stay, and better maintenance of independence. It should therefore be considered as a standard of care for elective colorectal surgery in elderly patients. See Video Abstract at http://links.lww.com/DCR/A981. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01646190. ENSAYO CONTROLADO ALEATORIZADO DE UN PROGRAMA DE RECUPERACIÓN INTENSIFICADA DEDICADO A PACIENTES DE EDAD AVANZADA DESPUÉS DE CIRUGÍA COLORECTAL: El Programa de Recuperación Intensificada es un enfoque de atención multimodal, multidisciplinaria y basada en evidencia para reducir el estrés quirúrgico perioperatorio, disminuir la morbilidad y la estancia hospitalaria, y mejorar la recuperación después de la cirugía. Este programa puede ser más beneficioso para las personas mayores (≥70 años), pero pocas series han investigado esta pregunta. OBJETIVO: Viabilidad y eficiencia del Programa de Recuperación Intensificada dedicado en personas de edad avanzada en comparación con la atención estándar. DISEÑO:: Este fue un estudio controlado, aleatorizado, sin método ciego. ESCENARIO: Este estudio se realizó en un único hospital universitario de alto volumen. PACIENTES: Un total de 150 pacientes de edad avanzada elegibles sometidos a cirugía colorrectal electiva fueron incluidos. INTERVENCIONES: Recuperación Intensificada después de cirugía electiva colorrectal en pacientes de edad avanzada. PRINCIPALES MEDIDAS DE RESULTADO: El resultado primario fue la morbilidad postoperatoria a 30 días. Los resultados adicionales incluyeron estancia hospitalaria, reingreso, dolor postoperatorio, consumo de opioides, preservación de la independencia y cumplimiento del protocolo. RESULTADOS: El Programa de Recuperación Intensificada reduce la morbilidad postoperatoria según la clasificación de Clavien-Dindo en un 47% en comparación con la atención estándar (35% vs 65%; p = 0.0003), número total de complicaciones (54 vs 118; p = 0.0003) y complicaciones infecciosas (13 vs 29; p = 0.001). No se registró ninguna fuga anastomótica en el grupo de Recuperación Intensificada frente a 5 para el grupo estándar (p = 0.01). El Programa de Recuperación Intensificada dio como resultado una estancia hospitalaria más corta (7 contra 12 días; p = 0.003) y una mejor conservación de la independencia (alta hospitalaria: 87% vs 67%; p = 0.005). Se pudo lograr un alto cumplimiento del protocolo del 77.2% en esta población. De acuerdo con el análisis multivariable, el Programa de Recuperación Intensificada se asoció fuertemente con la reducción de morbilidad (OR = 0.23; IC 95%: 0.09-0.57; p = 0.001), menos complicaciones graves (OR = 0.36; IC 95%: 0.15-0.84; p = 0.02) y estancia hospitalaria más corta (OR = 2.07; IC 95%: 1.33-3.22; p = 0.001). LIMITACIONES: Las limitaciones fueron un centro único de reclutamiento y la imposibilidad de que los pacientes o el profesional de la salud tuvieran cegamiento debido a la naturaleza de este programa multimodal. CONCLUSIONES: El Programa de recuperación Intensificada es seguro y mejora la recuperación postoperatoria en pacientes de edad avanzada, con menor morbilidad, menor estancia hospitalaria y mejor mantenimiento de la independencia. Por lo tanto, debe considerarse como un estándar de atención para la cirugía colorrectal electiva en pacientes de edad avanzada. Vea el Resumen en video en http://links.lww.com/DCR/A981.

Changes in Hepatic Blood Flow and Liver Function during Closed Abdominal Hyperthermic Intraperitoneal Chemotherapy following Cytoreduction Surgery.

BACKGROUND: The increase in intra-abdominal pressure (IAP) during closed abdominal hyperthermic intraperitoneal chemotherapy (HIPEC) leads to major haemodynamic changes and potential organ dysfunction. We investigated these effects on hepatic blood flow (HBF) and liver function in patients undergoing HIPEC following cytoreductive surgery and fluid management guided by dynamic preload indices. METHODS: In this prospective observational clinical study including 15 consecutive patients, we evaluated HBF by transesophageal echocardiography and liver function by determination of the indocyanine green plasma disappearance rate (ICG-PDR). Friedman's two-way analysis of variance by ranks and Wilcoxon signed-rank test were performed for statistical analysis. RESULTS: During HIPEC, HBF was markedly reduced, resulting in the loss of any pulsatile Doppler flow signal in all but one patient. The ICG-PDR, expressed as median (interquartile 25-75), decreased from 23 (20-30) %/min to 18 (12.5-19) %/min (p < 0.001). Despite a generous crystalloid infusion rate (27 (22-35) ml/kg/h), cardiac index decreased during the increased IAP period, inferior vena cava diameter decreased, stroke volume variation and pulse pressure variation increased, lung compliance dropped, and there was an augmentation in plateau pressure. All changes were significant (p < 0.001) and reversed to baseline values post HIPEC. CONCLUSION: Despite optimizing intravenous fluids during closed abdominal HIPEC, we observed a marked decrease in HBF and liver function. Both effects were transient and limited to the period of HIPEC but could influence the choice between closed or open abdominal cavity procedure for HIPEC and should be considered in similar clinical situations of increased IAP.

Evaluation of unfractionated heparin and recombinant hirudin on survival in a sustained ovine endotoxin shock model.

OBJECTIVE: To compare and evaluate the potential benefit of two different anticoagulation regimens during endotoxemia in an ovine model. DESIGN: Animal prospective randomized and controlled study following preliminary dose-range study conforming with the Guide for the Care and Use of Laboratory Animals as promulgated by the Council of the American Physiologic Society and reviewed by the Ethical Committee for Animal Research of our institution. SETTING: Laboratories of anesthesiological investigations and hemostasis, primary care university medical center. SUBJECTS: Twenty-two adult sheep of either sex, weighing 29-42 kg (mean 35.8 kg), surgically instrumented for chronic studies and randomly allocated to receive three different treatment groups: unfractionated heparin (40 units.kg.hr; n = 7), recombinant hirudin (500 units.kg.hr; n = 7), or saline (nonanticoagulated controls; n = 8). INTERVENTIONS: Ovine model of severe endotoxin shock induced by a continuous intravenous endotoxin infusion over 72 hrs (10 ng.kg.min ). MEASUREMENTS AND MAIN RESULTS: Endotoxin infusion alone produced a progressive hypotensive, hyperdynamic shock state with right ventricle failure leading to the death of all animals of the control group within 44 hrs (median, 12 hrs). Heparin profoundly improved survival rate in this model, whereas effective anticoagulation with hirudin did not significantly increase the survival rate compared with controls. Animals in the control group died from disseminated intravascular coagulation, metabolic acidosis, and hemorrhagic pulmonary edema, whereas sheep treated with hirudin died from severe pulmonary edema (hypoxemia, increased alveoloarterial oxygen gradient associated with an increased wet/dry lung weight ratio) in the absence of disseminated intravascular coagulation. CONCLUSIONS: We conclude that systemic anticoagulation with the thrombin inhibitor hirudin is without benefit in this sheep model of lethal endotoxemia, whereas anticoagulation with heparin affords not only effective prevention of endotoxin-induced coagulation disorders but also global protection with prevention of respiratory decompensation and thus markedly improves survival rate in this situation.