Department of Surgery, Catharina Hospital, Eindhoven, Netherlands; Tytgat Institute for Intestinal and Liver Research, Academic Medical Centre, Amsterdam, Netherlands.
Department of Surgery, Catharina Hospital, Eindhoven, Netherlands; GROW School of Oncology and Developmental Biology, Maastricht University, Maastricht, Netherlands.
Lancet Gastroenterol Hepatol. 2018 Apr;3(4):242-251. doi: 10.1016/S2468-1253(18)30031-1. Epub 2018 Feb 14.
Postoperative ileus and anastomotic leakage severely impair recovery after colorectal resection. We investigated the effect of perioperative lipid-enriched enteral nutrition versus standard care on the risk of postoperative ileus, anastomotic leakage, and other clinical outcomes.
We did an international, multicentre, double-blind, randomised, controlled trial of patients (≥18 years) undergoing elective colorectal surgery with primary anastomosis at six clinical centres in the Netherlands and Denmark. Patients were randomly assigned (1:1), stratified by location (colonic and rectal) and type of surgery (laparoscopic and open), via online randomisation software, with block sizes of six, to receive either continuous lipid-enriched enteral tube feeding from 3 h before until 6 h after surgery (intervention) or no perioperative nutrition (control). Surgeons, patients, and researchers were masked to treatment allocation for the entire study period. The primary outcome was postoperative ileus. Secondary outcomes included anastomotic leakage, pneumonia, preoperative gastric volumes, time to functional recovery, length of hospital stay, the need for additional interventions, intensive care unit admission, postoperative inflammatory response, and surgical complications. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02175979, and trialregister.nl, number NTR4670.
Between July 28, 2014, and February 20, 2017, 280 patients were randomly assigned, 15 of whom were excluded after random allocation because they fulfilled one or more exclusion criteria. 265 patients received perioperative nutrition (n=132) or standard care (n=133) and were included in the analyses. A postoperative ileus occurred in 37 (28%) patients in the intervention group versus 29 (22%) in the control group (risk ratio [RR] 1·09, 95% CI 0·95-1·25; p=0·24). Anastomotic leakage occurred in 12 (9%) patients in the intervention group versus 11 (8%) in the control group (RR 1·01, 95% CI 0·94-1·09; p=0·81). Pneumonia occurred in ten (8%) patients in the intervention group versus three (2%) in the control group (RR 1·06, 95% CI 1·00-1·12; p=0·051). All other secondary outcomes were similar between groups (all p>0·05).
Perioperative lipid-enriched enteral nutrition in patients undergoing elective colorectal surgery has no advantage over standard care in terms of postoperative complications.
Netherlands Organisation for Health Research and Development (ZonMW), Fonds NutsOhra, and Danone Research.
术后肠梗阻和吻合口漏严重影响结直肠切除术后的恢复。我们研究了围手术期富含脂肪的肠内营养与标准护理对术后肠梗阻、吻合口漏和其他临床结局的影响。
我们在荷兰和丹麦的 6 个临床中心进行了一项国际性、多中心、双盲、随机对照试验，纳入了接受择期结直肠手术且有原发性吻合的患者（年龄≥18 岁）。患者通过在线随机软件按位置（结肠和直肠）和手术类型（腹腔镜和开放）以 1:1 的比例、6 个为一组进行分层随机分组，接受手术前 3 小时至手术后 6 小时持续输注富含脂肪的肠内管饲（干预组）或不接受围手术期营养（对照组）。外科医生、患者和研究人员在整个研究期间对治疗分配均设盲。主要结局是术后肠梗阻。次要结局包括吻合口漏、肺炎、术前胃容量、功能恢复时间、住院时间、需要额外干预、入住重症监护病房、术后炎症反应和手术并发症。分析采用意向治疗。本研究在 ClinicalTrials.gov 注册，编号为 NCT02175979，在 trialregister.nl 注册，编号为 NTR4670。
在 2014 年 7 月 28 日至 2017 年 2 月 20 日期间，共随机分配了 280 名患者，其中 15 名在随机分配后因符合一项或多项排除标准而被排除。265 名患者接受了围手术期营养（n=132）或标准护理（n=133），并纳入了分析。干预组 37 名（28%）患者发生术后肠梗阻，对照组 29 名（22%）患者发生术后肠梗阻（风险比[RR] 1.09，95%CI 0.95-1.25；p=0.24）。干预组 12 名（9%）患者发生吻合口漏，对照组 11 名（8%）患者发生吻合口漏（RR 1.01，95%CI 0.94-1.09；p=0.81）。干预组 10 名（8%）患者发生肺炎，对照组 3 名（2%）患者发生肺炎（RR 1.06，95%CI 1.00-1.12；p=0.051）。两组其他次要结局相似（均 p＞0.05）。
在接受择期结直肠手术的患者中，围手术期富含脂肪的肠内营养与标准护理相比，在术后并发症方面没有优势。
荷兰健康研究与发展组织（ZonMW）、Fonds NutsOhra 和达能研究。
