title: Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02378948 and Dutch trial registry: NTR4972; Pre-results.
authors: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors: Gijs H K
authors: GH
authors: Berkelmans
authors: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors: Bas J W
authors: BJ
authors: Wilts
authors: Department of Surgery, Hospital Group Twente, Almelo, Twente, The Netherlands.
authors: Ewout A
authors: EA
authors: Kouwenhoven
authors: Division of Surgery, CLINTEC, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors: Koshi
authors: K
authors: Kumagai
authors: Division of Surgery, CLINTEC, Karolinska Institutet and Center for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.
authors: Magnus
authors: M
authors: Nilsson
authors: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors: Teus J
authors: TJ
authors: Weijs
authors: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors: Grard A P
authors: GA
authors: Nieuwenhuijzen
authors: Department of Surgery, Hospital Group Twente, Almelo, Twente, The Netherlands.
authors: Marc J
authors: MJ
authors: van Det
authors: Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
authors: Misha D P
authors: MD
authors: Luyer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019587:Dietary Supplements; D004435:Eating; D004750:Enteral Nutrition / Q000379:methods*; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D009752:Nutritional Status; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D055815:Young Adult