Pre-operative oral nutritional supplementation with dietary advice versus dietary advice alone in weight-losing patients with colorectal cancer: single-blind randomized controlled trial.
Pre-operative oral nutritional supplementation with dietary advice versus dietary advice alone in weight-losing patients with colorectal cancer: single-blind randomized controlled trial.
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DOI：
10.1002/jcsm.12170
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发表时间：
2017-06
期刊：
影响因子：
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通讯作者：
Todd C
中科院分区：
文献类型：
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作者：
Burden ST;Gibson DJ;Lal S;Hill J;Pilling M;Soop M;Ramesh A;Todd C
术前体重减轻一直与术后发病率增加相关。该研究旨在确定术前口服营养补充剂（ONS）和饮食建议是否能减少术后并发症。单盲随机对照试验。在6家医院（2013年11月1日至2015年2月28日），采用分层区组（1：1比例）对术前体重减轻> 1 kg/3 - 6个月的结直肠癌患者进行随机分组。干预组给予ONS 250 mL/d（10.1 KJ/mL，蛋白质0.096 g/mL），并给予饮食指导。对照组仅接受饮食指导。从诊断到手术前一天给予口服营养补充剂。研究小组对分组设盲。主要结局是发生一次或多次手术部位感染（SSI）或胸部感染的患者;次要结局包括体重减轻百分比、总并发症和身体成分测量。使用未校正和校正分析进行意向治疗分析。需要88个样本量。在101名参与者中，（55名ONS，46名对照）97名接受了手术。在意向治疗分析中，对照组有21/45（47%）例患者发生感染-SSI或胸部感染，而ONS组有17/55（30%）例患者发生感染。在未校正分析中，患者发生SSI或胸部感染的比值比为0.532（P = 0.135，置信区间0.232至1.218），当校正基线随机差异（年龄、性别、体重减轻百分比和癌症分期）时为0.341（P = 0.031，置信区间0.128至0.909）。ONS组在随机化后第一个时间点的术前体重减轻百分比为4.1%[四分位距（IQR）1.7 - 7.0]，而ONS组为6.7%（IQR 2.6 - 10.8）对照品（Mann-Whitney U P = 0.021），术后ONS组为7.4%（IQR 4.3 - 10.0），对照组为10.2%（IQR 5.1 - 18.5）（P = 0.016）。与单独的饮食建议相比，ONS导致患者在结直肠癌手术后感染较少，体重减轻较少。我们已经证明，术前口服营养补充剂可以改善体重减轻的结直肠癌患者的临床结局。
Pre‐operative weight loss has been consistently associated with increased post‐operative morbidity. The study aims to determine if pre‐operative oral nutritional supplements (ONSs) with dietary advice reduce post‐operative complications. Single‐blinded randomized controlled trial. People with colorectal cancer scheduled for surgery with pre‐operative weight loss >1 kg/3–6 months were randomized by using stratified blocks (1:1 ratio) in six hospitals (1 November 2013–28 February 2015). Intervention group was given 250 mL/day ONS (10.1 KJ and 0.096 g protein per mL) and dietary advice. Control group received dietary advice alone. Oral nutritional supplements were administered from diagnosis to the day preceding surgery. Research team was masked to group allocation. Primary outcome was patients with one or more surgical site infection (SSI) or chest infection; secondary outcomes included percentage weight loss, total complications, and body composition measurements. Intention‐to‐treat analysis was performed with both unadjusted and adjusted analyses. A sample size of 88 was required. Of 101 participants, (55 ONS, 46 controls) 97 had surgery. In intention‐to‐treat analysis, there were 21/45 (47%) patients with an infection—either an SSI or chest infection in the control group vs. 17/55 (30%) in the ONS group. The odds ratio of a patient incurring either an SSI or chest infection was 0.532 (P = 0.135 confidence interval 0.232 to 1.218) in the unadjusted analysis and when adjusted for random differences at baseline (age, gender, percentage weight loss, and cancer staging) was 0.341 (P = 0.031, confidence interval 0.128 to 0.909). Pre‐operative percentage weight loss at the first time point after randomization was 4.1% [interquartile range (IQR) 1.7–7.0] in ONS group vs. 6.7% (IQR 2.6–10.8) in controls (Mann–Whitney U P = 0.021) and post‐operatively was 7.4% (IQR 4.3–10.0) in ONS group vs. 10.2% (IQR 5.1–18.5) in controls (P = 0.016). Compared with dietary advice alone, ONS resulted in patients having fewer infections and less weight loss following surgery for colorectal cancer. We have demonstrated that pre‐operative oral nutritional supplementation can improve clinical outcome in weight losing patients with colorectal cancer.