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NUTritional Route In Esophageal resectioN Trial.


- candidate number15311
- NTR NumberNTR4136
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2013
- Secondary IDsNL39949.060.12 CCMO
- Public TitleNUTritional Route In Esophageal resectioN Trial.
- Scientific TitleNUTritional Route In Esophageal resectioN Trial.
- ACRONYMThe NUTRIENT trial
- hypothesisEarly oral intake after esophagectomy is feasible and safe.
- Healt Condition(s) or Problem(s) studiedEsophagectomy, Nutrition, Early oral intake
- Inclusion criteriaage > 18 years
written informed consent
indication for esophagectomy
- Exclusion criteriainablitity for oral intake
mental retardation
swallowing disorder
weight loss of >15% at start of surgery
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-aug-2013
- planned closingdate31-dec-2014
- Target number of participants50
- Interventions- De intervention consists of an oral intake scheme that is started from postoperative day one, under supervision of a dietician. Previously patients undergoing esophagectomy were kept nill-by-mouth untill day 5-7 postoperative, however, in this trial we will investigate if it is feasible and safe to start oral intake early after esophagectomy. In other wordt: patients will start a liquid diet from postoperative day 1, while previously they were not allowed to eat untill day 5-7 after the operation.
- There is no control group, for this is a single arm descriptive phase 2 trial.
- Duration of the intervention is not applicable to this study, because it consists of early oral intake. It is the timepoint that the oral intake is started that is relevant here.
- Primary outcomeThe effect of an early oral intake regimen on the percentage and severity (according to the modified Clavien Dindo classification for surgical complications) of anastomotic leakage and pneumonia.
- Secondary outcome- Daily caloric intake during the postoperative admission
- Need and amount of artificial nutrition (naso-jejunal tube feeding / parenteral nutrition)
- Occurrence of vomiting
- Placement of a nasogastric tube
- Length of hospital stay
- Hospital re-admissions within 30 days of discharge
- Complications classified according to the Clavien-Dindo classification
- Need for ICU admission and total length of ICU stay
- TimepointsAll primairy and secondary outcome measures are measured at the moment of discharge except for 2.
1. The caloric intake is measured on day 5 postoperative.
2. The hospital readmissions are determined within 30 days of discharge.
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Misha Luyer
- CONTACT for SCIENTIFIC QUERIES Misha Luyer
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven,
- PublicationsN/A
- Brief summaryThe Nutrient Trial is a single arm feasibility trial investigating early oral intake after esophagectomy. Primarily the impact on anastomotic leakage and pneumonia rate and severitiy will be carefully monitored.
- Main changes (audit trail)
- RECORD22-aug-2013 - 9-sep-2013


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