No registrations found.
ID
Source
Brief title
Health condition
esophagectomy (slokdarm resectie)
nutrition (voeding)
early oral intake (vroege orale voeding)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
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
Background summary
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.
Study objective
Early oral intake after esophagectomy is feasible and safe.
Study design
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.
Intervention
- 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.
Michelangelolaan 2
Misha Luyer
Eindhoven 5623 EJ
The Netherlands
m.luyer@maastrichtuniversity.nl
Michelangelolaan 2
Misha Luyer
Eindhoven 5623 EJ
The Netherlands
m.luyer@maastrichtuniversity.nl
Inclusion criteria
age > 18 years
written informed consent
indication for esophagectomy
Exclusion criteria
inablitity for oral intake
mental retardation
swallowing disorder
weight loss of >15% at start of surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3851 |
| NTR-old | NTR4136 |
| CCMO | NL39949.060.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39631 |