Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

Gijs H K Berkelmans, Bas J W Wilts, Ewout A Kouwenhoven, Koshi Kumagai, Magnus Nilsson, Teus J Weijs, Grard A P Nieuwenhuijzen, Marc J van Det, Misha D P Luyer, Gijs H K Berkelmans, Bas J W Wilts, Ewout A Kouwenhoven, Koshi Kumagai, Magnus Nilsson, Teus J Weijs, Grard A P Nieuwenhuijzen, Marc J van Det, Misha D P Luyer

Abstract

Introduction: Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy.

Methods and analysis: This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant.

Ethics and dissemination: Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is required before randomisation. All data will be collected using an online database with adequate security measures.

Trial registration numbers: NCT02378948 and Dutch trial registry: NTR4972; Pre-results.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Study protocol flow chart. POD5, postoperative day 5.

References

    1. Shewale JB, Correa AM, Baker CM et al. , University of Texas MD Anderson Esophageal Cancer Collaborative Group. Impact of a fast-track esophagectomy protocol on esophageal cancer patient outcomes and hospital charges. Ann Surg 2015;261:1114–23. 10.1097/SLA.0000000000000971
    1. Hur H, Kim SG, Shim JH et al. . Effect of early oral feeding after gastric cancer surgery: a result of randomized clinical trial. Surgery 2011;149:561–8. 10.1016/j.surg.2010.10.003
    1. Klappenbach RF, Yazyi FJ, Alonso Quintas F et al. . Early oral feeding versus traditional postoperative care after abdominal emergency surgery: a randomized controlled trial. World J Surg 2013;37:2293–9. 10.1007/s00268-013-2143-1
    1. Lassen K, Kjaeve J, Fetveit T et al. . Allowing normal food at will after major upper gastrointestinal surgery does not increase morbidity: a randomized multicenter trial. Ann Surg 2008;247:721–9. 10.1097/SLA.0b013e31815cca68
    1. Pragatheeswarane M, Muthukumarassamy R, Kadambari D et al. . Early oral feeding vs. traditional feeding in patients undergoing elective open bowel surgery—a randomized controlled trial. J Gastrointest Surg 2014;18:1017–23.
    1. Reissman P, Teoh TA, Cohen SM et al. . Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg 1995;222:73–7. 10.1097/00000658-199507000-00012
    1. Weijs TJ, Berkelmans GH, Nieuwenhuijzen GA et al. . Routes for early enteral nutrition after esophagectomy. A systematic review. Clin Nutr 2015;34:1–6.
    1. Fujita T, Daiko H, Nishimura M. Early enteral nutrition reduces the rate of life-threatening complications after thoracic esophagectomy in patients with esophageal cancer. Eur Surg Res 2012;48:79–84. 10.1159/000336574
    1. Xiao-Bo Y, Qiang L, Xiong Q et al. . Efficacy of early postoperative enteral nutrition in supporting patients after esophagectomy. Minerva Chir 2014;69:37–46.
    1. Watters JM, Kirkpatrick SM, Norris SB et al. . Immediate postoperative enteral feeding results in impaired respiratory mechanics and decreased mobility. Ann Surg 1997;226:369–77. doi:discussion 77-80.
    1. Bolton JS, Conway WC, Abbas AE. Planned delay of oral intake after esophagectomy reduces the cervical anastomotic leak rate and hospital length of stay. J Gastrointest Surg 2014;18:304–9. 10.1007/s11605-013-2322-2
    1. Tomaszek SC, Cassivi SD, Allen MS et al. . An alternative postoperative pathway reduces length of hospitalisation following oesophagectomy. Eur J Cardiothorac Surg 2010;37:807–13. 10.1016/j.ejcts.2009.09.034
    1. Willcutts KF, Chung MC, Erenberg CL et al. . Early oral feeding as compared with traditional timing of oral feeding after upper gastrointestinal surgery: a systematic review and meta-analysis. Ann Surg 2016;264:54–63. 10.1097/SLA.0000000000001644
    1. Weijs TJ, Berkelmans GHK, Nieuwenhuijzen GAP et al. . Immediate postoperative oral nutrition following esophagectomy; a multicenter clinical trial. Ann Thorac Surg 2016. [Epub ahead of print 11 Jun 2016].
    1. Van Dam RM, Hendry PO, Coolsen MME et al. . Initial experience with a multimodal enhanced recovery programme in patients undergoing liver resection. Br J Surg 2008;95:969–75. 10.1002/bjs.6227
    1. van Dam RM, Wong-Lun-Hing EM, van Breukelen GJP et al. . Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS programme (ORANGE II-Trial): study protocol for a randomised controlled trial. Trials 2012;13:54 10.1186/1745-6215-13-54
    1. Vlug MS, Bartels SAL, Wind J et al. . Which fast track elements predict early recovery after colon cancer surgery? Colorectal Dis 2012;14:1001–8.
    1. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol 1953;39:368–76. 10.3109/00016925309136722
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13. 10.1097/
    1. Aaronson NK, Ahmedzai S, Bergman B et al. . The European Organisation for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–76. 10.1093/jnci/85.5.365
    1. Weijs TJ, Seesing MF, van Rossum PS et al. . Internal and external validation of a multivariable model to define hospital-acquired pneumonia after esophagectomy. J Gastrointest Surg 2016;20:680–7. 10.1007/s11605-016-3083-5
    1. Force ADT, Ranieri VM, Rubenfeld GD et al. . Acute respiratory distress syndrome: the Berlin definition. JAMA 2012;307:2526–33. 10.1001/jama.2012.5669
    1. Low DE, Alderson D, Cecconello I et al. . International consensus on standardization of data collection for complications associated with esophagectomy (ECCG). Ann Surg 2015;262:286–94. 10.1097/SLA.0000000000001098

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