Age Nutrition Chirurgie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial

BMC Geriatrics

Study Protocol

Max Haine¹  Thomas Gilbert¹  Elisabetta Kuczewski²  Marine Dupuis³  Laurent Villeneuve⁴  Sylvie Bin-Dorel⁴  Claire Falandry⁵  Guillaume Passot⁶  Olivier Glehen⁶  Marc Bonnefoy⁷ 

[1] Service de Médecine Gériatrique, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France;Service d’Hygiène Épidémiologie Infectiovigilance et Prévention, Hospices Civils de Lyon, Lyon, France;Unité de Recherche Clinique, Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon, France;Unité de Recherche Clinique, Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon, France;Université de Lyon, EAM Parcours Santé Systémique, 4128, Lyon, France;Université Lyon 1, Lyon, France;Université Lyon 1, EMR 3738, Oullins, France;Oncologie Médicale, Centre d’Investigation des Thérapeutiques en Oncologie et Hématologie de Lyon (CITOHL), Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Lyon, France;Université Lyon 1, EMR 3738, Oullins, France;Service de Chirurgie Viscérale et Endocrinienne, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France;Université Lyon 1, Lyon, France;Service de Médecine Gériatrique, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France;INSERM U1060, Laboratoire CarMeN (cardiovasculaire, métabolisme, diabétologie et nutrition), Université Claude Bernard Lyon 1, Pierre-Bénite, France;

关键词: Vulnerable;    Nutrition;    Cancer;    Colorectal tumor;    Stepped wedge;   

DOI  :  10.1186/s12877-016-0402-3

 received in 2016-07-27, accepted in 2016-12-21,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundUndernutrition prior to major abdominal surgery is frequent and increases morbidity and mortality, especially in older patients. The management of undernutrition reduces postoperative complications. Nutritional management should be a priority in patient care during the preoperative period. However undernutrition is rarely detected and the guidelines are infrequently followed. Preoperative undernutrition screening should allow a better implementation of the guidelines.Methods/designThe ANC (“Age Nutrition Chirurgie”) study is an interventional, comparative, prospective, multicenter, randomized protocol based on the stepped wedge trial design. For the intervention, the surgeon will inform the patient of the establishment of a systematic preoperative geriatric assessment that will allow the preoperative diagnosis of the nutritional status and the implementation of an adjusted nutritional support in accordance with the nutritional guidelines. The primary outcome measure is to determine the impact of the geriatric intervention on the level of perioperative nutritional management, in accordance with the current European guidelines. The implementation of the intervention in the five participating centers will be rolled-out sequentially over six time periods (every six months). Investigators must recommend that all patients aged 70 years or over and who are consulting for a surgery for a colorectal cancer should consider participating in this study.DiscussionThe ANC study is based on an original methodology, the stepped wedge trial design, which is appropriate for evaluating the implementation of a geriatric and nutritional assessment during the perioperative period. We describe the purpose of this geriatric intervention, which is expected to apply the ESPEN and SFNEP recommendations through the establishment of an undernutrition screening and a management program for patients with cancer. This intervention should allow a decrease in patient morbidity and mortality due to undernutrition.Trial registrationThis study is registered in ClinicalTrials.gov NCT02084524 on March 11, 2014 (retrospectively registered).

【 授权许可】

CC BY   
© The Author(s). 2017