Dupuis Marine, Kuczewski Elisabetta, Villeneuve Laurent, Bin-Dorel Sylvie, Haine Max, Falandry Claire, Gilbert Thomas, Passot Guillaume, Glehen Olivier, Bonnefoy Marc
Unité de Recherche Clinique, Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon, France.
Service d'Hygiène Épidémiologie Infectiovigilance et Prévention, Hospices Civils de Lyon, Lyon, France.
BMC Geriatr. 2017 Jan 7;17(1):10. doi: 10.1186/s12877-016-0402-3.
Undernutrition 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/DESIGN: The 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.
The 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.
This study is registered in ClinicalTrials.gov NCT02084524 on March 11, 2014 (retrospectively registered).
腹部大手术前营养不良情况常见，会增加发病率和死亡率，在老年患者中尤为如此。营养不良的管理可减少术后并发症。在术前阶段，营养管理应是患者护理的首要任务。然而，营养不良很少被检测到，且很少遵循相关指南。术前营养不良筛查应能更好地落实这些指南。
方法/设计：ANC（“年龄、营养、外科手术”）研究是一项基于阶梯楔形试验设计的干预性、对比性、前瞻性、多中心随机方案。对于干预措施，外科医生将告知患者进行系统的术前老年医学评估，这将有助于术前诊断营养状况，并根据营养指南实施调整后的营养支持。主要结局指标是根据当前欧洲指南，确定老年医学干预对围手术期营养管理水平的影响。五个参与中心将在六个时间段（每六个月）依次推行该干预措施。研究人员必须建议所有70岁及以上且因结直肠癌手术前来咨询的患者考虑参与本研究。
ANC研究基于一种原创方法，即阶梯楔形试验设计，该方法适用于评估围手术期老年医学和营养评估的实施情况。我们描述了这项老年医学干预的目的，即期望通过建立营养不良筛查和癌症患者管理计划来应用ESPEN和SFNEP的建议。这种干预应能降低因营养不良导致的患者发病率和死亡率。
本研究于2014年3月11日在ClinicalTrials.gov上注册，注册号为NCT02084524（追溯注册）。
