Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection.

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).

The price of decreased mortality in the operative management of diverticulitis.

BACKGROUND: Healthcare costs in the United States are increasing. It is thought that as cost increases, outcomes should improve. The aim of this study was to analyze patient charges and mortality in the operative management of diverticulitis over time. METHODS: A retrospective analysis of the Nationwide Inpatient Sample database was performed. Adults with diverticulitis who underwent laparoscopic or open partial colectomy were identified by ICD-9 codes. Multivariate analyses examined in-hospital mortality and total charges. Results were adjusted for age, race, gender, Charlson comorbidity index, surgical approach (open vs. laparoscopic), and insurance status. RESULTS: From 1998 to 2010, 148,348 patients had a partial colectomy for diverticulitis. After adjusting for other covariates and inflation, the average charge of hospitalization per admission increased by $34,057 from 1998 to 2010. In the same observation period, adjusted in-hospital mortality decreased significantly by 2005 compared to 1998 (p < 0.001, OR 0.77, 95% CI 0.68-0.88) and remained unchanged for the remainder of the study period. Additionally, laparoscopic management was associated with lower rate of charge increase compared to open management (p < 0.001), such that charges are currently higher for open management than laparoscopic. CONCLUSION: In-hospital mortality following partial colectomy for diverticulitis has improved over time, most dramatically after 2005. With decreasing mortality, an increase in hospital charges is observed on an annual basis. However, while mortality reached a plateau after 2005, overall charges continue to rise.

Variation of outcome and charges in operative management for diverticulitis.

BACKGROUND: Outcomes after surgery for diverticulitis are of continued interest to improve quality of care. The aim of this study was to assess variations in mortality, length of stay, and patient charges between geographic regions of the United States. METHODS: A retrospective analysis of the Nationwide Inpatient Sample database was performed. Adults with diverticulitis who underwent laparoscopic or open segmental colectomy were identified using ICD-9 codes. Subset analyses were performed by state and then compared. Outcomes included mortality, length of stay (LOS), and total charges. Results were adjusted for age, race, gender, findings of peritonitis, stoma placement, Charlson comorbidity index, and insurance status on multivariate analysis. RESULTS: 148,874 patients underwent segmental colectomy for diverticulitis from 1998 to 2010. Using California as the comparison state and after adjusting for covariates, in-hospital mortality was significantly higher in the State of New York (OR 1.32; 95 % CI 1.13-1.55; P < 0.05) and Mississippi (OR 2.84; 95 % CI 1.24-6.51, P < 0.02). Wisconsin had a significant lower mortality rate (OR 0.74; 95 % CI 0.59-0.94, P < 0.01). LOS was 1.4 days longer in New York and 0.54 days shorter in Wisconsin than in California (P < 0.01). Patients with age >40 years, findings of peritonitis, and without private insurance had higher in-hospital mortality and longer length of stay. Average hospital charges differed dramatically between the states in the observation period. The highest hospital charges occurred in California, Nebraska, and Nevada while lowest occurred in Maryland, Wisconsin and Utah. CONCLUSIONS: Patients who undergo surgical treatment for diverticulitis in the United States have high geographic variation in mortality, LOS, and hospital charges despite adjusting for demographic and socioeconomic factors. Further analysis should be performed to identify the causes of outlier regions, with the goal of improving and standardizing best practices.

Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study.

BACKGROUND: Our primary objective was to demonstrate the utility and feasibility of the intraoperative assessment of colon and rectal perfusion using fluorescence angiography (FA) during left-sided colectomy and anterior resection. Anastomotic leak (AL) after colorectal resection increases morbidity, mortality, and, in cancer cases, recurrence rates. Inadequate perfusion may contribute to AL. The PINPOINT Endoscopic Fluorescence Imaging System allows for intraoperative assessment of anastomotic perfusion. STUDY DESIGN: This is a prospective, multicenter, open-label, clinical trial that assessed the feasibility and utility of FA for intraoperative perfusion assessment during left-sided colectomy and anterior resection at 11 centers in the United States. RESULTS: A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Diverticulitis (44%), rectal cancer (25%), and colon cancer (21%) were the most prevalent indications for surgery. The mean level of anastomosis was 10 ± 4 cm from the anal verge. Splenic-flexure mobilization was performed in 81% and high ligation of the inferior mesenteric artery in 61.9% of patients. There was a 99% success rate for FA, and FA changed surgical plans in 11 (8%) patients, with the majority of changes occurring at the time of transection of the proximal margin (7%). Overall morbidity rates were 17%. The anastomotic leak rate was 1.4% (n = 2). There were no anastomotic leaks in the 11 patients who had a change in surgical plan based on intraoperative perfusion assessment with FA. CONCLUSIONS: PINPOINT is a safe and feasible tool for intraoperative assessment of tissue perfusion during colorectal resection. There were no anastomotic leaks in patients in whom the anastomosis was revised based on inadequate perfusion with FA.