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Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial.

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. Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. t.derooij@amc.nl. Clinical Research Unit, Academic Medical Center, PO Box 22660, 1100, DD, Amsterdam, the Netherlands. m.g.dijkgraaf@amc.nl. Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. o.r.busch@amc.nl. Department of Gastroenterology and Hepatology, Academic Medical Center, PO Box 22660, 1100, DD, Amsterdam, the Netherlands. j.j.bergman@amc.nl. Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. d.ubbink@amc.nl. Department of Surgery, Gelre Hospital, PO Box 9014, 7300, DS, Apeldoorn, the Netherlands. p.van.duijvendijk@gelre.nl. Department of Gastroenterology, Gelre Hospital, PO Box 9014, 7300, DS, Apeldoorn, the Netherlands. w.erkelens@gelre.nl. Department of Surgery, University Medical Center Utrecht, PO Box 85500, , 3508, GA, Utrecht, the Netherlands. i.q.molenaar@umcutrecht.nl. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, PO Box 85500, 3508, GA, Utrecht, the Netherlands. j.f.monkelbaan@umcutrecht.nl. Department of Surgery, Canisius Wilhelmina Hospital, PO Box 9015, 6500, GS, Nijmegen, the Netherlands. crosman@cwz.nl. Department of Gastroenterology, Canisius Wilhelmina Hospital, PO Box 9015, 6500, GS, Nijmegen, the Netherlands. a.tan@cwz.nl. Department of Surgery, Hospital Gelderse Vallei, PO Box 9025, 6710, HN, Ede, the Netherlands. kruytf@zgv.nl. Department of Gastroenterology, Hospital Gelderse Vallei, PO Box 9025, 6710, HN, Ede, the Netherlands. bacd@zgv.nl. Department of Gastroenterology and Hepatology, Academic Medical Center, PO Box 22660, 1100, DD, Amsterdam, the Netherlands. e.mathus-vliegen@amc.nl. Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. m.g.besselink@amc.nl.

Trials. 2015;:119
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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/DESIGN 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. DISCUSSION 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. TRIAL REGISTRATION Dutch Trial Register: NTR4420 , date registered 5-feb-2014.

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