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Plaatsing van voedingssondes in de dunne darm via elektromagnetische geleiding op de verpleegafdeling of via kijkonderzoek op de endoscopie-afdeling


- candidate number16360
- NTR NumberNTR4420
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-feb-2014
- Secondary IDsNL47229.018.13  AMC
- Public TitlePlaatsing van voedingssondes in de dunne darm via elektromagnetische geleiding op de verpleegafdeling of via kijkonderzoek op de endoscopie-afdeling
- Scientific TitleCortrak bedside Or Regular Endoscopic placement of nasoenteral feeding tubes in surgical patients: a randomized controlled multicenter non-inferiority trial
- ACRONYMCORE trial
- hypothesisElectromagnetic (EM) guided bedside placement of a nasoenteral feeding tube is at least as effective as endoscopic placement at lower costs.
- Healt Condition(s) or Problem(s) studiedGastroparesis, Tube feeding, Surgery, Endoscopy, Delayed gastric emptying, Electromagnetic guidance
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria: - Admitted on a gastrointestinal surgical ward - Requiring post-pyloric enteral nutrition, because of severe gastroparesis/gastric stasis not responding to prokinetics, intolerance of oral feeding due to gastroduodenal inflammation, postprandial pain or passage disorder due to swelling or outside pressure onto the duodenum, or proximal enteric fistulae.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study: - Younger than 18 years - Contraindication for enteral feeding - History of oesophageal varices, stenosis or obstruction of the upper digestive tract or recent oesophagectomy - Presence of an implanted medical device that may be affected by electromagnetic field of the Cortrak system or vice versa (except for pacemakers and defibrillators) - Necessity for tube placement during weekends or holidays - Unable to provide informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2015
- Target number of participants154
- InterventionsIntervention: EM-guided bedside nasoenteral feeding tube placement by a trained nurse on the clinical ward. Comparison: Endoscopic nasoenteral feeding tube placement by a gastroenterologist in the endoscopy department.
- Primary outcomePrimary outcome is reinsertion of a feeding tube via the nose and oesophagus (either after initial unsuccessful placement or after dislodgement or blockage of an initially successfully placed tube).
- Secondary outcomeSecondary outcomes are amongst others: patient discomfort and satisfaction, costs, budget impact, success rate of tube placement, duration of procedure, time lapse between physician order and tube placement and feed initiation, time to full-dose enteral nutrition, feeding-related interventions, length of tube stay, tube-related morbidity and length of hospital stay.
- TimepointsBoth patient groups are followed for as long as they are hospitalized and during any outpatient department or day-care visit related to the tube.
- Trial web sitewww.core-trial.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES A. Gerritsen
- CONTACT for SCIENTIFIC QUERIESMD PhD Marc G.H. Besselink
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Corpak MedSystems U.K.
- Publications
- Brief summarySubjects will be recruited in the Netherlands in the AMC Amsterdam, UMC Utrecht, Gelre Hospital Apeldoorn, CWZ Nijmegen and Gelderse Vallei Ede.
- Main changes (audit trail)
- RECORD5-feb-2014 - 8-jun-2015


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