Surgical treatment for colorectal cancer: Analysis of the influence of an enhanced recovery programme on long-term oncological outcomes-a study protocol for a prospective, multicentre, observational cohort study

Introduction The evidence currently available from enhanced recovery after surgery (ERAS) programmes concerns their benefits in the immediate postoperative period, but there is still very little evidence as to whether their correct implementation benefits patients in the long term. The working hypothesis here is that, due to the lower response to surgical aggression and lower rates of postoperative complications, ERAS protocols can reduce colorectal cancer-related mortality. The main objective of this study is to analyse the impact of an ERAS programme for colorectal cancer on 5-year survival. As secondary objectives, we propose to analyse the weight of each of the predefined items in the oncological results as well as the quality of life. Methods and analysis A multicentre prospective cohort study was conducted in patients older than 18 years of age who are scheduled to undergo surgery for colorectal cancer. The study involved 12 hospitals with an implemented enhanced recovery protocol according to the guidelines published by the Spanish National Health Service. The intervention group includes patients with a minimum implementation level of 70%, and the control group includes those who fail to reach this level. Compliance will be studied using 18 key performance indicators, and the results will be analysed using cancer survival indicators, including overall survival, cancer-specific survival and relapse-free survival. The time to recurrence, perioperative morbidity and mortality, hospital stay and quality of life will also be studied, the latter using the validated EuroQol Five questionnaire. The propensity index method will be used to create comparable treatment and control groups, and a multivariate regression will be used to study each variable. The Kaplan-Meier estimator will be used to estimate survival and the log-rank test to make comparisons. A p value of less than 0.05 (two-tailed) will be considered to be significant. Ethics and dissemination Ethical approval for this study was obtained from the Aragon Ethical Committee (C.P.-C.I. PI20/086) on 4 March 2020. The findings of this study will be submitted to peer-reviewed journals (BMJ Open, JAMA Surgery, Annals of Surgery, British Journal of Surgery). Abstracts will be submitted to relevant national and international meetings.The present research study was awarded a Ministerio de Ciencia e Innovación health research project grant (PI19/00291) from the Carlos III Institute of the Spanish National Health Service as part of the 2019 call for Strategic Action in Health

Efectos de la inmunonutrición perioperatoria en pacientes normonutridos operados de cáncer colorrectal laparoscópico en un régimen de rehabilitación multimodal

A pesar de los avances que se han producido en los últimos años en el manejo quirúrgico de los pacientes con cáncer colorrectal (CCR), las complicaciones postoperatorias son frecuentes. Recientemente se han introducido en la práctica clínica los suplementos alimenticios enriquecidos con inmunonutrientes, sin embargo, los beneficios de la inmunonutrición en pacientes sometidos a cirugía laparoscópica colorrectal dentro de un programa de rehabiltitación multimodal (PRM) se desconocen. OBJETIVO: Determinar si el uso conjunto de formulas enterales nutricionales suplementadas con inmunonutrientes en pacientes operados de CCR, mediante abordaje laparoscópico dentro de un PRM, disminuye la incidendia de infección del sitio quirúrgico (ISQ) en comparación con el asesoramiento dietético. MATERIAL Y MÉTODOS: Estudio prospectivo y aleatorizado en el que se incluyeron pacientes normonutridos que iban a ser sometidos a resección colorrectal laparoscópica, dentro de un PRM. Los pacientes fueron aleatorizados en dos grupos de tratamiento paralelos, aporte de nutrición oral habitual no suplementada vs suplementos enriquecidos con inmunonutrientes, durante 7 días antes de la resección colorrectal y 5 días después de la intervención quirúrgica. La estancia y la morbimortalidad postoperatoria fueron estudiadas. RESULTADOS: Un total de 128 pacientes fueron asignados de forma aleatoria. Al inicio del estudio, ambos grupos eran comparables en cuanto a edad, sexo, riesgo quirúrgico, comorbilidad y en cuanto a parámetros analíticos y nutricionales. La mediana de duración de la estancia hospitalaria postoperatoria fue de 5 días, sin diferencias entre los grupos. La infección del sitio quirúrgico incisional (ISQi) diferió significativamente entre los grupos (11.50% vs. 0.00%, p=0.006). No se objetivaron otras diferencias entre los dos grupos. CONCLUSIONES: La suplementación con inmunonutrientes dentro de un PRM reduce la ISQi en pacientes sometidos a cirugía colorrectal laparoscópica

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)