Early oral intake after esophagectomy is feasible and safe.
ID
Bron
Verkorte titel
Aandoening
esophagectomy (slokdarm resectie)
nutrition (voeding)
early oral intake (vroege orale voeding)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The 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.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
Early oral intake after esophagectomy is feasible and safe.
Onderzoeksopzet
All 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.
Onderzoeksproduct en/of interventie
- 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.
Publiek
Michelangelolaan 2
Misha Luyer
Eindhoven 5623 EJ
The Netherlands
m.luyer@maastrichtuniversity.nl
Wetenschappelijk
Michelangelolaan 2
Misha Luyer
Eindhoven 5623 EJ
The Netherlands
m.luyer@maastrichtuniversity.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
age > 18 years
written informed consent
indication for esophagectomy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
inablitity for oral intake
mental retardation
swallowing disorder
weight loss of >15% at start of surgery
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL3851 |
NTR-old | NTR4136 |
CCMO | NL39949.060.12 |
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OMON | NL-OMON39631 |