Herbert Georgia, Perry Rachel, Andersen Henning Keinke, Atkinson Charlotte, Penfold Christopher, Lewis Stephen J, Ness Andrew R, Thomas Steven
NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and the University of Bristol, Education and Research Centre, Upper Maudlin Street, Bristol, Avon, UK, BS2 8AE.
Cochrane Database Syst Rev. 2018 Oct 24;10(10):CD004080. doi: 10.1002/14651858.CD004080.pub3.
This is an update of the review last published in 2011. It focuses on early postoperative enteral nutrition after lower gastrointestinal surgery. Traditional management consisted of 'nil by mouth', where patients receive fluids followed by solids after bowel function has returned. Although several trials have reported lower incidence of infectious complications and faster wound healing upon early feeding, other trials have shown no effect. The immediate advantage of energy intake (carbohydrates, protein or fat) could enhance recovery with fewer complications, and this warrants a systematic evaluation.
To evaluate whether early commencement of postoperative enteral nutrition (within 24 hours), oral intake and any kind of tube feeding (gastric, duodenal or jejunal), compared with traditional management (delayed nutritional supply) is associated with a shorter length of hospital stay (LoS), fewer complications, mortality and adverse events in patients undergoing lower gastrointestinal surgery (distal to the ligament of Treitz).
We searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library 2017, issue 10), Ovid MEDLINE (1950 to 15 November 2017), Ovid Embase (1974 to 15 November 2017). We also searched for ongoing trials in ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (15 November 2017). We handsearched reference lists of identified studies and previous systematic reviews.
We included randomised controlled trials (RCT) comparing early commencement of enteral nutrition (within 24 hours) with no feeding in adult participants undergoing lower gastrointestinal surgery.
Two review authors independently assessed study quality using the Cochrane 'Risk of bias' tool tailored to this review and extracted data. Data analyses were conducted according to the Cochrane recommendations.We rated the quality of evidence according to GRADE.Primary outcomes were LoS and postoperative complications (wound infections, intraabdominal abscesses, anastomotic dehiscence, pneumonia).Secondary outcomes were: mortality, adverse events (nausea, vomiting), and quality of life (QoL).LoS was estimated using mean difference (MD (presented as mean +/- SD). For other outcomes we estimated the common risk ratio (RR) and calculated the associated 95% confidence intervals. For analysis, we used an inverse-variance random-effects model for the primary outcome (LoS) and Mantel-Haenszel random-effects models for the secondary outcomes. We also performed Trial Sequential Analyses (TSA).
We identified 17 RCTs with 1437 participants undergoing lower gastrointestinal surgery. Most studies were at high or unclear risk of bias in two or more domains. Six studies were judged as having low risk of selection bias for random sequence generation and insufficient details were provided for judgement on allocation concealment in all 17 studies. With regards to performance and deception bias; 14 studies reported no attempt to blind participants and blinding of personnel was not discussed either. Only one study was judged as low risk of bias for blinding of outcome assessor. With regards to incomplete outcome data, three studies were judged to be at high risk because they had more than 10% difference in missing data between groups. For selective reporting, nine studies were judged as unclear as protocols were not provided and eight studies had issues with either missing data or incomplete reporting of results.LOS was reported in 16 studies (1346 participants). The mean LoS ranged from four days to 16 days in the early feeding groups and from 6.6 days to 23.5 days in the control groups. Mean difference (MD) in LoS was 1.95 (95% CI, -2.99 to -0.91, P < 0.001) days shorter in the early feeding group. However, there was substantial heterogeneity between included studies (I = 81, %, Chi = 78.98, P < 0.00001), thus the overall quality of evidence for LoS is low. These results were confirmed by the TSA showing that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit.We found no differences in the incidence of postoperative complications: wound infection (12 studies, 1181 participants, RR 0.99, 95%CI 0.64 to 1.52, very low-quality evidence), intraabdominal abscesses (6 studies, 554 participants, RR 1.00, 95%CI 0.26 to 3.80, low-quality evidence), anastomotic leakage/dehiscence (13 studies, 1232 participants, RR 0.78, 95%CI 0.38 to 1.61, low-quality evidence; number needed to treat for an additional beneficial outcome (NNTB) = 100), and pneumonia (10 studies, 954 participants, RR 0.88, 95%CI 0.32 to 2.42, low-quality evidence; NNTB = 333).Mortality was reported in 12 studies (1179 participants), and showed no between-group differences (RR = 0.56, 95%CI, 0.21 to 1.52, P = 0.26, I = 0%, Chi = 3.08, P = 0.96, low-quality evidence). The most commonly reported cause of death was anastomotic leakage, sepsis and acute myocardial infarction.Seven studies (613 participants) reported vomiting (RR 1.23, 95%CI, 0.96 to 1.58, P = 0.10, I = 0%, Chi = 4.98, P = 0.55, low-quality evidence; number needed to treat for an additional harmful outcome (NNTH) = 19), and two studies (118 participants) reported nausea (RR 0.95, 0.71 to 1.26, low-quality evidence). Four studies reported combined nausea and vomiting (RR 0.94, 95%CI 0.51 to 1.74, very low-quality evidence). One study reported QoL assessment; the scores did not differ between groups at 30 days after discharge on either QoL scale EORTC QLQ-C30 or EORTC QlQ-OV28 (very low-quality evidence).
AUTHORS' CONCLUSIONS: This review suggests that early enteral feeding may lead to a reduced postoperative LoS, however cautious interpretation must be taken due to substantial heterogeneity and low-quality evidence. For all other outcomes (postoperative complications, mortality, adverse events, and QoL) the findings are inconclusive, and further trials are justified to enhance the understanding of early feeding for these. In this updated review, only a few additional studies have been included, and these were small and of poor quality.To improve the evidence, future trials should address quality issues and focus on clearly defining and measuring postoperative complications to allow for better comparison between studies. However due to the introduction of fast track protocols which already include an early feeding component, future trials may be challenging. A more feasible trial may be to investigate the effect of differing postoperative energy intake regimens on relevant outcomes.
这是对2011年发表的综述的更新。它聚焦于下消化道手术后的早期肠内营养。传统管理方式为“禁食”,即患者在肠道功能恢复后先接受流食,再逐渐过渡到固体食物。尽管多项试验报告称早期进食可降低感染并发症的发生率并加快伤口愈合,但其他试验并未显示出效果。能量摄入(碳水化合物、蛋白质或脂肪)的直接益处可能会促进恢复并减少并发症,因此有必要进行系统评估。
评估与传统管理方式(延迟营养供给)相比,术后早期肠内营养(24小时内)、经口摄入以及任何形式的管饲(胃管、十二指肠管或空肠管)是否与接受下消化道手术(Treitz韧带远端)患者的住院时间缩短、并发症减少、死亡率降低及不良事件减少相关。
我们检索了Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆2017年第10期)、Ovid MEDLINE(1950年至2017年11月15日)、Ovid Embase(1974年至2017年11月15日)。我们还在ClinicalTrials.gov和世界卫生组织国际临床试验注册平台(2017年11月15日)上检索了正在进行的试验。我们手工检索了已识别研究和先前系统综述的参考文献列表。
我们纳入了比较下消化道手术成年参与者术后早期肠内营养(24小时内)与不进食的随机对照试验(RCT)。
两位综述作者使用为本综述量身定制的Cochrane“偏倚风险”工具独立评估研究质量并提取数据。数据分析按照Cochrane推荐进行。我们根据GRADE对证据质量进行评级。主要结局为住院时间和术后并发症(伤口感染、腹腔内脓肿、吻合口裂开、肺炎)。次要结局为:死亡率、不良事件(恶心、呕吐)和生活质量(QoL)。住院时间采用均值差(MD(表示为均值±标准差))进行估计。对于其他结局,我们估计了共同风险比(RR)并计算了相关的95%置信区间。为进行分析,我们对主要结局(住院时间)使用逆方差随机效应模型,对次要结局使用Mantel-Haenszel随机效应模型。我们还进行了试验序贯分析(TSA)。
我们识别出17项RCT,共1437名接受下消化道手术的参与者。大多数研究在两个或更多领域存在高偏倚风险或偏倚风险不明确。六项研究在随机序列生成方面被判定为选择偏倚风险低,而在所有17项研究中,关于分配隐藏的判断所提供的细节不足。关于实施和检测偏倚,14项研究报告未尝试对参与者进行盲法,也未讨论对人员的盲法。只有一项研究在结局评估者盲法方面被判定为低偏倚风险。关于不完整结局数据,三项研究被判定为高风险,因为它们组间缺失数据差异超过10%。对于选择性报告,九项研究被判定为不明确,因为未提供方案,八项研究存在缺失数据或结果报告不完整的问题。16项研究(1346名参与者)报告了住院时间。早期喂养组的平均住院时间为4天至16天,对照组为6.6天至23.5天。早期喂养组的住院时间均值差(MD)缩短了1.95天(95%CI,-2.99至-0.91,P<0.001)。然而,纳入研究之间存在显著异质性(I² = 81%,Chi² = 78.98,P<0.00001),因此住院时间的总体证据质量较低。TSA证实了这些结果,表明累积Z曲线越过了试验序贯监测的获益边界。我们发现术后并发症的发生率没有差异:伤口感染(12项研究,1181名参与者,RR 0.99,95%CI 0.64至1.52,极低质量证据)、腹腔内脓肿(6项研究,554名参与者,RR 1.00,95%CI 0.26至3.80,低质量证据)、吻合口漏/裂开(13项研究,1232名参与者,RR 0.78,95%CI 0.38至1.61,低质量证据;额外有益结局的需治疗人数(NNTB) = 100)和肺炎(10项研究,954名参与者,RR 0.88,95%CI 0.32至2.42,低质量证据;NNTB = 333)。12项研究(1179名参与者)报告了死亡率,组间无差异(RR = 0.56,95%CI,0.21至1.52,P = 0.26,I² = 0%,Chi² = 3.08,P = 0.96,低质量证据)。最常见的死亡原因是吻合口漏、败血症和急性心肌梗死。七项研究(613名参与者)报告了呕吐(RR 1.23,95%CI,0.96至1.58,P = 0.10,I² = 0%,Chi² = 4.98,P = 0.55,低质量证据;额外有害结局的需治疗人数(NNTH) = 19),两项研究(118名参与者)报告了恶心(RR 0.95,95%CI 0.71至1.26,低质量证据)。四项研究报告了恶心和呕吐合并情况(RR 0.94,95%CI 0.51至1.74,极低质量证据)。一项研究报告了生活质量评估;在出院后30天,无论是EORTC QLQ-C30生活质量量表还是EORTC QlQ-OV28量表,两组得分均无差异(极低质量证据)。
本综述表明,早期肠内喂养可能会缩短术后住院时间,但由于存在显著异质性和低质量证据,必须谨慎解读。对于所有其他结局(术后并发症、死亡率、不良事件和生活质量),研究结果尚无定论,有必要进行进一步试验以加深对这些方面早期喂养的理解。在本次更新的综述中,仅纳入了少数额外研究,且这些研究规模小且质量差。为提高证据质量,未来试验应解决质量问题,并专注于清晰定义和测量术后并发症,以便在研究之间进行更好的比较。然而,由于已经引入了包含早期喂养成分的快速康复方案,未来试验可能具有挑战性。一个更可行的试验可能是研究不同的术后能量摄入方案对相关结局的影响。