title: Study protocol for the nutritional route in oesophageal resection trial: a single-arm feasibility trial (NUTRIENT trial).
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NTR4136.
authors.affiliation: Department of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Teus J
authors.initials: TJ
authors.lastname: Weijs
authors.affiliation: Department of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
authors.forename: Grard A P
authors.initials: GA
authors.lastname: Nieuwenhuijzen
authors.affiliation: Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Jelle P
authors.initials: JP
authors.lastname: Ruurda
authors.affiliation: Department of Surgery, Ziekenhuisgroep Twente, Almelo, The Netherlands.
authors.forename: Ewout A
authors.initials: EA
authors.lastname: Kouwenhoven
authors.affiliation: Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.affiliation: Department of Surgery, Atrium Medisch Centrum, Heerlen, The Netherlands.
authors.forename: Meindert
authors.initials: M
authors.lastname: Sosef
authors.affiliation: Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Richard
authors.initials: R
authors.lastname: V Hillegersberg
authors.affiliation: Department of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
authors.forename: Misha D P
authors.initials: MD
authors.lastname: Luyer
mesh_terms: D004750:Enteral Nutrition / Q000379:methods*; D016629:Esophagectomy / Q000379:methods; D005240:Feasibility Studies; D006801:Humans; D019060:Minimally Invasive Surgical Procedures; D012107:Research Design
keywords: Nutrition & Dietetics