Higher Adherence to ERAS Society® Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study.

PURPOSE: The effectiveness of enhanced recovery after surgery (ERAS) pathways in patients undergoing bariatric surgery remains unclear. Our objective was to determine the effect of the ERAS elements on patient outcomes following elective bariatric surgery. MATERIALS AND METHODS: Prospective cohort study in adult patients undergoing elective bariatric surgery. Each participating center selected a single 3-month data collection period between October 2019 and September 2020. We assessed the 24 individual components of the ERAS pathways in all patients. We used a multivariable and multilevel logistic regression model to adjust for baseline risk factors, ERAS elements, and center differences RESULTS: We included 1419 patients. One hundred and fourteen patients (8%) developed postoperative complications. There were no differences in the incidence of overall postoperative complications between the self-designated ERAS and non-ERAS groups (54 (8.7%) vs. 60 (7.6%); OR, 1.14; 95% CI, 0.73-1.79; P = .56), neither for moderate-to-severe complications, readmissions, re-interventions, mortality, or hospital stay (2 [IQR 2-3] vs. 3 [IQR 2-4] days, 0.85; 95% CI, 0.62-1.17; P = .33) Adherence to the ERAS elements in the highest adherence quartile (Q1) was greater than 72.2%, while in the lowest adherence quartile (Q4) it was less than 55%. Patients with the highest adherence rates had shorter hospital stay (2 [IQR 2-3] vs. 3 [IQR 2-4] days, 1.54; 95% CI, 1.09-2.17; P = .015), while there were no differences in the other outcomes CONCLUSIONS: Higher adherence to ERAS Society® recommendations was associated with a shorter hospital stay without an increase in postoperative complications or readmissions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03864861.

Análisis de la pérdida ponderal a medio plazo después del bypass gastroyeyunal en Y de Roux y de la gastrectomía vertical: propuesta de gráficos de percentiles del porcentaje de peso total perdido para su uso en la práctica clínica diaria / Analysis of mid-term weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy: Proposed percentile charts for total weight loss percentages to be used in daily clinical practice

Introducción: El objetivo de este trabajo es analizar la evolución ponderal de las principales técnicas quirúrgicas bariátricas (bypass gastroyeyunal en Y de Roux [BPGY] y gastrectomía vertical [GV]) realizadas en un conjunto representativo de centros nacionales españoles, con el fin de confeccionar unos gráficos de percentiles del porcentaje de pérdida total de peso perdido durante los 3 primeros años después de la cirugía. Métodos: Se realiza un estudio de cohortes longitudinal retrospectivo a partir de los datos aportados por 9 centros hospitalarios españoles. Se han analizado los datos ponderales tanto en porcentaje de pérdida total de peso perdido como en porcentaje de exceso de peso perdido correspondientes al BPGY (n = 1.887) y a la GV (n = 1.210). Resultados: El BPGY sigue siendo la técnica más frecuentemente realizada en nuestra muestra nacional. En ambas técnicas quirúrgicas, la pérdida de peso máxima se produce a los 18 meses de la cirugía. Ambas técnicas siguen la misma evolución ponderal, aunque los valores del porcentaje de pérdida total de peso perdido sean inferiores en el caso de la GV a los 36 meses (29,3 ± 10 vs. 33,6 ± 10). La edad y el género son determinantes en los resultados ponderales (mejores en paciente más jóvenes para ambas técnicas y mejores en mujeres para el BPGY). Conclusiones: Los gráficos de percentiles del porcentaje de peso total perdido después de la cirugía bariátrica representan una herramienta muy útil y un avance importante en la calidad asistencial para el seguimiento ponderal del paciente

Introduction: The aim of this study is to analyze weight evolution after the main bariatric surgical techniques (Roux-en-Y gastric bypass [RYGB] and sleeve gastrectomy [SG]) performed at a representative sample of Spanish hospitals in order to develop percentile charts for the percentage of total weight loss during the first 3 years after surgery. Methods: A retrospective longitudinal cohort study was conducted based on the data provided by 9 Spanish hospitals. Weight data were analyzed both in % total weight loss and % excess weight lost corresponding to the RYGB (n = 1,887) and SG (n = 1,210). Results: RYGB continues to be the most frequently performed technique in our sample. In both surgical techniques, maximum weight loss occurred 18 months after surgery. Both techniques followed the same weight evolution, although the % total weight loss values were lower in the case of the SG after 36 months (29.3 ± 10 vs. 33.6 ± 10). Age and gender are decisive in the weight results (better in younger patients for both techniques and better in women for RYGB). Conclusions: Percentile charts of % total weight loss after bariatric surgery represent a very useful tool and an important advance in the quality of patient management

Analysis of mid-term weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy: Proposed percentile charts for total weight loss percentages to be used in daily clinical practice. / Análisis de la pérdida ponderal a medio plazo después del bypass gastroyeyunal en Y de Roux y de la gastrectomía vertical: propuesta de gráficos de percentiles del porcentaje de peso total perdido para su uso en la práctica clínica diaria.

INTRODUCTION: The aim of this study is to analyze weight evolution after the main bariatric surgical techniques (Roux-en-Y gastric bypass [RYGB] and sleeve gastrectomy [SG]) performed at a representative sample of Spanish hospitals in order to develop percentile charts for the percentage of total weight loss during the first 3 years after surgery. METHODS: A retrospective longitudinal cohort study was conducted based on the data provided by 9 Spanish hospitals. Weight data were analyzed both in % total weight loss and % excess weight lost corresponding to the RYGB (n=1,887) and SG (n=1,210). RESULTS: RYGB continues to be the most frequently performed technique in our sample. In both surgical techniques, maximum weight loss occurred 18 months after surgery. Both techniques followed the same weight evolution, although the % total weight loss values were lower in the case of the SG after 36 months (29.3±10 vs. 33.6±10). Age and gender are decisive in the weight results (better in younger patients for both techniques and better in women for RYGB). CONCLUSIONS: Percentile charts of % total weight loss after bariatric surgery represent a very useful tool and an important advance in the quality of patient management.

Rehabilitación multimodal en cirugía bariátrica / Enhanced recovery after bariatric surgery

Los protocolos de rehabilitación multimodal o recuperación intensificada (PRI) son programas de cuidado del paciente basados en la evidencia científica y orientados a mejorar su recuperación postoperatoria. Abarcan todos los aspectos implicados en el cuidado del paciente y requieren un manejo multidisciplinar, en el que intervienen varios especialistas. La aplicación de estos protocolos se está extendiendo ampliamente por diferentes tipos de cirugías abdominales y extraabdominales, incluyendo la cirugía bariátrica. Facultativos de diferentes especialidades, con experiencia en el tratamiento de pacientes obesos mórbidos, han formado parte del grupo de trabajo que desarrolló este protocolo. Para evaluar la evidencia científica actualizada, se realizó una búsqueda bibliográfica sobre PRI en cirugía bariátrica en diferentes bases de datos, estableciendo los niveles de calidad de evidencia y el grado de recomendación según la metodología GRADE. Se agruparon las actuaciones incluidas en la matriz temporal en 3 etapas: preoperatorio, perioperatorio y postoperatorio

Enhanced recovery after surgery (ERAS) protocols are care programs based on scientific evidence and focused on postoperative recovery. They encompass all aspects of patient care and require multidisciplinary management, with the participation of diverse specialists. The implementation of these protocols is being extended to several abdominal and extra-abdominal surgeries, including bariatric approaches. Diverse specialists with wide experience in the management of morbidly obese patients have taken part in the working group that developed this protocol. A bibliographic search about ERAS in bariatric surgery in several databases was performed to evaluate the current scientific evidence, establishing evidence levels and recommendations according to the GRADE methodology. The items included in this protocol are separated into preoperative, perioperative and postoperative guidelines

Enhanced recovery after bariatric surgery. / Rehabilitación multimodal en cirugía bariátrica.

Enhanced recovery after surgery (ERAS) protocols are care programs based on scientific evidence and focused on postoperative recovery. They encompass all aspects of patient care and require multidisciplinary management, with the participation of diverse specialists. The implementation of these protocols is being extended to several abdominal and extra-abdominal surgeries, including bariatric approaches. Diverse specialists with wide experience in the management of morbidly obese patients have taken part in the working group that developed this protocol. A bibliographic search about ERAS in bariatric surgery in several databases was performed to evaluate the current scientific evidence, establishing evidence levels and recommendations according to the GRADE methodology. The items included in this protocol are separated into preoperative, perioperative and postoperative guidelines.

Utilización de adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo: resultados preliminares del ensayo clínico fase iv multicéntrico, prospectivo, aleatorizado y controlado simple ciego: Protissucol001 / Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001

Introducción: Con el objetivo de demostrar la eficacia de los adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas, en enero de 2007 iniciamos un estudio multicéntrico, prospectivo, aleatorizado, controlado, simple ciego, sobre la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo mediante la utilización de adhesivos biológicos a base de fibrina. Material y métodos En enero de 2007 iniciamos un ensayo clínico multicéntrico en el que participan los hospitales Gregorio Marañón, Universitario de San Carlos y Hospital del Sureste, de Madrid sobre la prevención de defectos de cicatrización anastomótica mediante la aplicación de adhesivos biológicos a base de fibrina en la linea de sutura. Los pacientes reclutados se aleatorizan asignando al paciente en función de esta aleatorización a uno de los 2 grupos: grupo de estudio en el que se aplica adhesivo en la línea de sutura y grupo control en el que no se aplica. La variable principal del estudio es la presencia o ausencia de fugas. El ensayo ha sido aprobado por los correspondientes Comités de Ética e Investigación Clínica, por la Agencia Española del Medicamento y registrado en www.clinicaltrials.gov (NCT01306851). Ninguno de los autores manifiesta tener conflicto de interés con la empresa Baxter, que comercializa el producto en España. Resultados Desde enero de 2007 hasta noviembre de 2010, se ha reclutado a 104 pacientes que han sido asignados tras aleatorización, 52 al grupo de estudio y 52 al grupo control. Se han registrado 22 fugas anastomóticas de las cuales 7 en el grupo de estudio (13, 4%) y 15 en el grupo control (28, 8%) con un valor de la P de 0,046. El índice de riesgo de fugas fue de 0,384, es decir, se produce una reducción del 61% en las fugas de los pacientes a los que se aplica adhesivo biológico a (..) (AU)

Introduction: A multicentre, prospective, randomised, controlled, and simple blind clinicaltrial was started in January 2007, with the aim of demonstrating the eficacy of fibrin-based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract. Material and methods: A study on the prevention of anastomotic healing defects by applying biological adhesives along the suture line began in January 2007, and included the hospitals, Gregorio Marañón, Universitario de San Carlos, and Hospital del Sureste, in Madrid. The enrolled patients were randomised to one of 2 groups: the study group in which the adhesive was applied to the suture line, and a control group in which it was not applied. The primary outcome of the study was the presence or absence of leaks. The trial was approved by the corresponding Clinical Research Ethics Committees and the Spanish Medicines Agency(AEMPS) and registered www.clinicaltrials.gov (NCT01306851). The authors declared not to have any (..) (AU)

[Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001]. / Utilización de adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo: resultados preliminares del ensayo clínico fase iv multicéntrico, prospectivo, aleatorizado y controlado simple ciego: Protissucol001.

INTRODUCTION: A multicentre, prospective, randomised, controlled, and simple blind clinical trial was started in January 2007, with the aim of demonstrating the efficacy of fibrin-based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract. MATERIAL AND METHODS: A study on the prevention of anastomotic healing defects by applying biological adhesives along the suture line began in January 2007, and included the hospitals, Gregorio Marañón, Universitario de San Carlos, and Hospital del Sureste, in Madrid. The enrolled patients were randomised to one of 2 groups: the study group in which the adhesive was applied to the suture line, and a control group in which it was not applied. The primary outcome of the study was the presence or absence of leaks. The trial was approved by the corresponding Clinical Research Ethics Committees and the Spanish Medicines Agency (AEMPS) and registered www.clinicaltrials.gov (NCT01306851). The authors declared not to have any conflict of interests with the company, Baxter, which markets the product in Spain. RESULTS: A total of 104 patients were recruited between January 2007 and November 2010, of whom 52 were randomised to the study group, and 52 to the control group. A total of 22 anastomotic leaks were recorded, of which 7 (13.4%) were in the study group, and 15 (28.8%) in the control group (P=.046). The leak risk index was 0.384, which means that there was a 61% reduction in leaks in the patients who had the fibrin-based biological adhesive applied. There were 3 (5.7%) further surgeries in the study group, compared to 12 (23%) in the control group (P=.12). On analysing the mortality, it was observed that 3 patients in the study group and 4 patients in the control group died (5.7% vs. 7.7%, P=.5). No other significant differences were found as regards the type of suture, surgical time, or pre-surgical history, except that the use of drainages appeared to be a protective factor of anastomotic leak (P=.041), although the use or not of a drainage was not a controlled factor, but at the discretion of each surgeon. CONCLUSIONS: Our study demonstrates, significantly, that in the 104 patients in the study that fibrin based biological adhesives are capable of preventing anastomotic leaks in the high risk digestive tract, reducing the risk of leaks by 61% and a further surgeries. This is the first clinical trial that shows these significant results. If our results are maintained at the end of the study, it will show that anastomotic leaks can be prevented with the application of these adhesives, thus their application may be recommended in all the anastomosis of the high risk digestive tract.