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Open Access 01-12-2015 | Study protocol

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

Authors: Arja Gerritsen, Thijs de Rooij, Marcel G Dijkgraaf, Olivier R Busch, Jacques J Bergman, Dirk T Ubbink, Peter van Duijvendijk, G Willemien Erkelens, I Quintus Molenaar, Jan F Monkelbaan, Camiel Rosman, Adriaan C Tan, Philip M Kruyt, Dirk Jan Bac, Elisabeth M Mathus-Vliegen, Marc G Besselink

Published in: Trials | Issue 1/2015

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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Title: Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial
Authors: Arja Gerritsen
Thijs de Rooij
Marcel G Dijkgraaf
Olivier R Busch
Jacques J Bergman
Dirk T Ubbink
Peter van Duijvendijk
G Willemien Erkelens
I Quintus Molenaar
Jan F Monkelbaan
Camiel Rosman
Adriaan C Tan
Philip M Kruyt
Dirk Jan Bac
Elisabeth M Mathus-Vliegen
Marc G Besselink
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0633-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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