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食管癌切除术中营养途径的研究方案:一项单臂可行性试验(营养试验)

Study protocol for the nutritional route in oesophageal resection trial: a single-arm feasibility trial (NUTRIENT trial).

作者信息

Weijs Teus J, Nieuwenhuijzen Grard A P, Ruurda Jelle P, Kouwenhoven Ewout A, Rosman Camiel, Sosef Meindert, V Hillegersberg Richard, Luyer Misha D P

机构信息

Department of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.

Department of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.

出版信息

BMJ Open. 2014 Jun 6;4(6):e004557. doi: 10.1136/bmjopen-2013-004557.

DOI:10.1136/bmjopen-2013-004557
PMID:24907243
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4054648/
Abstract

INTRODUCTION

The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy.

METHODS AND ANALYSIS

This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered.

ETHICS AND DISSEMINATION

Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the study has been registered at the Dutch Trial Register, NTR4136. Results will be published and presented at international congresses.

DISCUSSION

We hypothesise that the oral route of feeding is safe and feasible following oesophagectomy, as has been shown previously for other types of gastrointestinal surgery. It is expected that early oral nutrition will result in enhanced recovery. Furthermore, complications related to artificial feeding, such as jejunostomy tube feeding, are believed to be reduced. However, (aspiration) pneumonia and anastomotic leakage are potential risks that are carefully monitored.

TRIAL REGISTRATION NUMBER

NTR4136.

摘要

引言

食管癌切除术后患者的最佳喂养途径尚不清楚。有人担心早期经口进食会增加肺炎和吻合口漏的发生率及严重程度。然而,在包括许多其他类型胃肠道手术后患者的研究以及动物实验中,早期经口进食已被证明是有益的,并能促进恢复。因此,我们旨在确定食管癌切除术后早期经口进食的可行性。

方法与分析

本研究是一项可行性试验,50例连续的患者将在食管癌切除术后直接开始经口进食。主要结局将是吻合口漏和(误吸性)肺炎的发生率及严重程度。临床参数将进行前瞻性记录,营养需求和摄入量将由营养师评估。手术并发症也将进行记录。

伦理与传播

本研究已获得埃因霍温卡塔琳娜医院医学伦理委员会的批准,并已在荷兰试验注册中心注册,注册号为NTR4136。研究结果将在国际学术会议上发表和展示。

讨论

我们假设,如同先前在其他类型胃肠道手术中所显示的那样,食管癌切除术后经口喂养途径是安全可行的。预计早期经口营养将促进恢复。此外,与人工喂养相关的并发症,如空肠造瘘管喂养,有望减少。然而,(误吸性)肺炎和吻合口漏是需要密切监测的潜在风险。

试验注册号

NTR4136。

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