The optimal feeding route has yet to be found(1). A nill by mouth regime is generally applied after an esophagectomy. However, early oral feeding has been shown to be feasible and safe (NUTRIENT 1). This study will investigate the best feeding route…
ID
Bron
Verkorte titel
Aandoening
esophageal cancer, esophagectomy, nutrition, postoperative complications, pulmonary complications, anastomic leakage, Quality of life
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Functional recovery
Achtergrond van het onderzoek
The Nutrient II is a 2 arm RCT investigating early oral intake versus delayed oral intake after esophagectomy. Primarily the impact on pulmonary complications and functional recovery. Nutritional status, surgical complications and quality of life is carefully monitored.
Doel van het onderzoek
The optimal feeding route has yet to be found(1). A nill by mouth regime is generally applied after an esophagectomy. However, early oral feeding has been shown to be feasible and safe (NUTRIENT 1). This study will investigate the best feeding route in terms of functional recovery, pulmonary complications, anastomotic leakage and quality of life.
Onderzoeksopzet
- Functional recovery: during admission.
- Pulmonary complications: within 30 days after surgery.
- Anastomotic leakage: within 30 days after surgery by clinical/radiological signs or confirmed by reoperation
- Nutritional status: calculation of caloric and protein intake on POD 2, 5 and 14 days (if patient is still admitted)
- Quality of life: baseline, 3 months, 6 months
Onderzoeksproduct en/of interventie
Early oral feeding after an esophagectomy. Patients will start a liquid oral diet directly postoperatively.
Control group: enteral feeding via a jejunostomy for 2 weeks after surgery.
Publiek
Gijs H.K. Berkelmans
P.O. Box 1350
Eindhoven 5623 EJ
The Netherlands
040-2397150
gijs.berkelmans@cze.nl
Wetenschappelijk
Gijs H.K. Berkelmans
P.O. Box 1350
Eindhoven 5623 EJ
The Netherlands
040-2397150
gijs.berkelmans@cze.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients that undergo a (minimally invasive) esophagectomy with intrathoracic anastomosis.
- written informed consent
- age >18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Inability for oral intake
- Inability to place a surgical feeding jejunostomy
- Mental retardation
- Swallowing disorder
- Achalasia
- Malnutrition (defined as >15% weight loss just before start of the surgery)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4856 |
| NTR-old | NTR4972 |
| CCMO | NL52591.060.15 |
| OMON | NL-OMON42802 |