학술논문
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.
Document Type
Academic Journal
Author
Ramirez-Rodriguez JM; Lozano Blesa University Clinical Hospital, Zaragoza, Aragón, Spain jramirez@unizar.es.; Aragon Health Sciences Institute, Zaragoza, Aragón, Spain.; Martinez-Ubieto J; Miguel Servet University Hospital, Zaragoza, Aragón, Spain.; Muñoz-Rodes JL; Miguel Hernandez University of Elche, Elche, Valenciana, Spain.; Rodriguez-Fraile JR; Health Service of Castilla-La Mancha, Guadalajara, Castilla-La Mancha, Spain.; Garcia-Erce JA; Navarre Health Service, Pamplona, Navarra, Spain.; Blanco-Gonzalez J; La Ribera Hospital, Alzira, Valenciana, Spain.; Del Valle-Hernandez E; General University Hospital Gregorio Maranon, Madrid, Spain.; Abad-Gurumeta A; Hospital Universitario Infanta Leonor, Madrid, Spain.; Centeno-Robles E; Complejo Asistencial de Palencia, Palencia, Spain.; Martinez-Perez C; General University Hospital Consortium of Valencia, Valencia, Comunitat Valenciana, Spain.; Leon-Arellano M; Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain.; Echazarreta-Gallego E; Hospital of Barbastro, Barbastro, Aragón, Spain.; Elia-Guedea M; Lozano Blesa University Clinical Hospital, Zaragoza, Aragón, Spain.; Pascual-Bellosta A; Miguel Servet University Hospital, Zaragoza, Aragón, Spain.; Miranda-Tauler E; Miguel Hernandez University of Elche, Elche, Valenciana, Spain.; Manuel-Vazquez A; Health Service of Castilla-La Mancha, Guadalajara, Castilla-La Mancha, Spain.; Balen-Rivera E; Navarre Health Service, Pamplona, Navarra, Spain.; Alvarez-Martinez D; La Ribera Hospital, Alzira, Valenciana, Spain.; Perez-Peña J; General University Hospital Gregorio Maranon, Madrid, Spain.; Abad-Motos A; Hospital Universitario Infanta Leonor, Madrid, Spain.; Redondo-Villahoz E; Complejo Asistencial de Palencia, Palencia, Spain.; Biosta-Perez E; General University Hospital Consortium of Valencia, Valencia, Comunitat Valenciana, Spain.; Guadalajara-Labajo H; Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain.; Ripollés-Melchor J; Hospital Universitario Infanta Leonor, Madrid, Spain.; Latre-Saso C; Hospital of Barbastro, Barbastro, Aragón, Spain.; Cordoba-Diaz de Laspra E; Lozano Blesa University Clinical Hospital, Zaragoza, Aragón, Spain.; Sanchez-Guillen L; Miguel Hernandez University of Elche, Elche, Valenciana, Spain.; Cabellos-Olivares M; Health Service of Castilla-La Mancha, Guadalajara, Castilla-La Mancha, Spain.; Longas-Valien J; Lozano Blesa University Clinical Hospital, Zaragoza, Aragón, Spain.; Ortega-Lucea S; Miguel Servet University Hospital, Zaragoza, Aragón, Spain.; Ocon-Breton J; Lozano Blesa University Clinical Hospital, Zaragoza, Aragón, Spain.; Arroyo-Sebastian A; Miguel Hernandez University of Elche, Elche, Valenciana, Spain.; Garcia-Olmo D; Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain.; Universidad Autonoma de Madrid, Madrid, Spain.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
Abstract
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.
Trial Registration Number: NCT04305314.
Competing Interests: Competing interests: J-MR-R reports grants from Instituto de Investigacion Carlos III, during the conduct of the study. J-AG-E reports grants and personal fees from Vifor Pharma, Zambon and Sandoz, outside the submitted work. JR-M reports personal fees from Fresenius Kabi, Edwards Lifesciences, Dextera Medical and MSD, outside the submitted work
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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.
Trial Registration Number: NCT04305314.
Competing Interests: Competing interests: J-MR-R reports grants from Instituto de Investigacion Carlos III, during the conduct of the study. J-AG-E reports grants and personal fees from Vifor Pharma, Zambon and Sandoz, outside the submitted work. JR-M reports personal fees from Fresenius Kabi, Edwards Lifesciences, Dextera Medical and MSD, outside the submitted work
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)