title: Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs.
  
  
  METHODS
  The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications.
  
  
  CONCLUSIONS
  The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes.
  
  
  BACKGROUND
  Dutch Trial Register: NTR4420 , date registered 5-feb-2014.
authors: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. a.gerritsen@amc.nl.|Department of Surgery, University Medical Center Utrecht, PO Box 85500, , 3508, GA, Utrecht, the Netherlands. a.gerritsen@amc.nl.
authors: Arja
authors: A
authors: Gerritsen
authors: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. t.derooij@amc.nl.
authors: Thijs
authors: T
authors: de Rooij
authors: Clinical Research Unit, Academic Medical Center, PO Box 22660, 1100, DD, Amsterdam, the Netherlands. m.g.dijkgraaf@amc.nl.
authors: Marcel G
authors: MG
authors: Dijkgraaf
authors: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. o.r.busch@amc.nl.
authors: Olivier R
authors: OR
authors: Busch
authors: Department of Gastroenterology and Hepatology, Academic Medical Center, PO Box 22660, 1100, DD, Amsterdam, the Netherlands. j.j.bergman@amc.nl.
authors: Jacques J
authors: JJ
authors: Bergman
authors: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. d.ubbink@amc.nl.
authors: Dirk T
authors: DT
authors: Ubbink
authors: Department of Surgery, Gelre Hospital, PO Box 9014, 7300, DS, Apeldoorn, the Netherlands. p.van.duijvendijk@gelre.nl.
authors: Peter
authors: P
authors: van Duijvendijk
authors: Department of Gastroenterology, Gelre Hospital, PO Box 9014, 7300, DS, Apeldoorn, the Netherlands. w.erkelens@gelre.nl.
authors: G Willemien
authors: GW
authors: Erkelens
authors: Department of Surgery, University Medical Center Utrecht, PO Box 85500, , 3508, GA, Utrecht, the Netherlands. i.q.molenaar@umcutrecht.nl.
authors: I Quintus
authors: IQ
authors: Molenaar
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, PO Box 85500, 3508, GA, Utrecht, the Netherlands. j.f.monkelbaan@umcutrecht.nl.
authors: Jan F
authors: JF
authors: Monkelbaan
authors: Department of Surgery, Canisius Wilhelmina Hospital, PO Box 9015, 6500, GS, Nijmegen, the Netherlands. crosman@cwz.nl.
authors: Camiel
authors: C
authors: Rosman
authors: Department of Gastroenterology, Canisius Wilhelmina Hospital, PO Box 9015, 6500, GS, Nijmegen, the Netherlands. a.tan@cwz.nl.
authors: Adriaan C
authors: AC
authors: Tan
authors: Department of Surgery, Hospital Gelderse Vallei, PO Box 9025, 6710, HN, Ede, the Netherlands. kruytf@zgv.nl.
authors: Philip M
authors: PM
authors: Kruyt
authors: Department of Gastroenterology, Hospital Gelderse Vallei, PO Box 9025, 6710, HN, Ede, the Netherlands. bacd@zgv.nl.
authors: Dirk Jan
authors: DJ
authors: Bac
authors: Department of Gastroenterology and Hepatology, Academic Medical Center, PO Box 22660, 1100, DD, Amsterdam, the Netherlands. e.mathus-vliegen@amc.nl.
authors: Elisabeth M
authors: EM
authors: Mathus-Vliegen
authors: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. m.g.besselink@amc.nl.
authors: Marc G
authors: MG
authors: Besselink
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D004574:Electromagnetic Fields; D004724:Endoscopy; D004750:Enteral Nutrition / Q000295:instrumentation*; D018589:Gastroparesis / Q000628:therapy*; D006801:Humans; D007441:Intubation, Gastrointestinal / Q000379:methods*; D011183:Postoperative Complications / Q000628:therapy*; D012107:Research Design