Cortrak bedside Or Regular Endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE): a randomized controlled multicenter non-inferiority trial

Cortrak bedside Or Regular Endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE): a randomized controlled multicenter non-inferiority trial - CORE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40389

Enrollment

154

Registered

2014-02-04

Start date

2014-03-13

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delayed gastric emptying Gastroparese

Interventions

EM-guided bedside nasoenteral feeding tube placement by a trained nurse on the clinical ward as compared to endoscopic nasoenteral feeding tube placement by a gastroenterologist in the endoscopy dep

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: - 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. - For UMC Utrecht and St.Antonius Hospital: After previous gastrointestinal, HPB or splenic surgery

Exclusion criteria

Exclusion criteria: Patients: - 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

Design outcomes

Primary

Measure	Time frame
Primary outcome is reinsertion of the feeding tube via the nose and oesophagus (either after initial unsuccessful placement or after dislodgement or blockage of an initially successfully placed tube).	—

Secondary

Measure	Time frame
Secondary 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)