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

Completed

Conditions: delayed gastric emptying
10017977
Gastroparese
10017998

Registration Number: NL-OMON40389

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 154

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is reinsertion of the feeding tube via the nose and oesophagus<br /><br>(either after initial unsuccessful placement or after dislodgement or blockage<br /><br>of an initially successfully placed tube).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are amongst others: patient discomfort and satisfaction,<br /><br>costs, budget impact, success rate of tube placement, duration of procedure,<br /><br>time lapse between physician order and tube placement and feed initiation, time<br /><br>to full-dose enteral nutrition, feeding-related interventions, length of tube<br /><br>stay, tube-related morbidity and length of hospital stay.</p><br>