Plaatsing van voedingssondes in de dunne darm via elektromagnetische geleiding op de verpleegafdeling of via kijkonderzoek op de endoscopie-afdeling
- Conditions
- EN: Gastroparesis, delayed gastric emptying, surgery, nasoenteral feeding, endoscopy, electomagnetic guidanceNL: Gastroparese, vertraagde maagontlediging, chirurgie, sondevoeding, endoscopie, elektromagnetische geleiding
- Registration Number
- NL-OMON26355
- Lead Sponsor
- Academic Medical Center, Amsterdam, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 154
In 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.
A 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary 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 Outcome Measures
Name Time Method 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.