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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.

Gerritsen A, de Rooij T, Dijkgraaf MG, Busch OR, Bergman JJ, Ubbink DT, van Duijvendijk P, Erkelens GW, Molenaar IQ, Monkelbaan JF, Rosman C, Tan AC, Kruyt PM, Bac DJ, Mathus-Vliegen EM, Besselink MG - Trials (2015)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. a.gerritsen@amc.nl.

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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Related in: MedlinePlus

Flow chart of participants in the CORE trial according to CONSORT.
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Fig1: Flow chart of participants in the CORE trial according to CONSORT.

Mentions: Eligible patients will be recruited on the clinical ward by the principal investigators or a designated substitute. After obtaining informed consent, patients will be randomized centrally by the study coordinator using an online randomization module (Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands) in a 1:1 ratio between EM guided and endoscopic tube placement (FigureĀ 1).Figure 1


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

Gerritsen A, de Rooij T, Dijkgraaf MG, Busch OR, Bergman JJ, Ubbink DT, van Duijvendijk P, Erkelens GW, Molenaar IQ, Monkelbaan JF, Rosman C, Tan AC, Kruyt PM, Bac DJ, Mathus-Vliegen EM, Besselink MG - Trials (2015)

Flow chart of participants in the CORE trial according to CONSORT.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4390000&req=5

Fig1: Flow chart of participants in the CORE trial according to CONSORT.
Mentions: Eligible patients will be recruited on the clinical ward by the principal investigators or a designated substitute. After obtaining informed consent, patients will be randomized centrally by the study coordinator using an online randomization module (Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands) in a 1:1 ratio between EM guided and endoscopic tube placement (FigureĀ 1).Figure 1

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. a.gerritsen@amc.nl.

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.

Show MeSH
Related in: MedlinePlus