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Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial.

Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, 305 Zhongshan East Road, Nanjing, China. Department of Medical Statistics, Jinling Hospital of the First School of Clinical Medicine, Southern Medical University, 305 Zhongshan East Road, Nanjing, China; Department of Biostatistics, School of Public Health, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, Nanjing, China. Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, 37 Guo Xue Rd., Chengdu, China. Department of General Surgery, First Medical Center of Chinese PLA General Hospital, 28 Fuxing Road, Haidian District, Beijing, China. Department of Gastrointestinal Surgery, The First Affiliated Hospital of Air Force Medical University, Changle West Road, Xincheng District, Xi'an, China. Department of Hepatobiliary Pancreatic Surgery, Changhai Hospital, The Second Military Medical University, 168 Changhai Road, Yangpu District, Shanghai, China. Department of General Surgery, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, No.301 Yanchang Middle Road, Shanghai, China. Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan, Wangfujing Street, Dongcheng, Beijing, China. Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, No.16 Jiangsu Rd, Qingdao, China. Department of General Surgery, The 2nd Affiliated Hospital of Harbin Medical University, 246 Xuefu Road, Nangang District, Haerbin, China. Department of General Surgery, The Second Affiliated Hospital, Army Medical University, Xinqiao Main Street, Shapingba District, Chongqing, China. Department of General Surgery, First Affiliated Hospital of Kunming Medical University, 295 Xichang Road, Kunming, China. Department of Intensive Care, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP Ede, the Netherlands; Division of Human Nutrition and Health, Wageningen University & Research, HELIX (Building 124), Stippeneng 4, 6708 WE Wageningen, the Netherlands. Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, 305 Zhongshan East Road, Nanjing, China. Electronic address: wangxinying@nju.edu.cn.

Clinical nutrition (Edinburgh, Scotland). 2021;(12):5802-5811
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Abstract

BACKGROUND & AIMS The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system. METHODS This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population. RESULTS A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, -0.6%; [95% confidence interval (CI), -6.2%-4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant. CONCLUSIONS Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).

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