No registrations found.
ID
Source
Brief title
Health condition
esophageal cancer, esophagectomy, nutrition, postoperative complications, pulmonary complications, anastomic leakage, Quality of life
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Functional recovery
Secondary outcome
- Pulmonary complications (Pneumonia, Acute respiratory distress syndrome (ARDS), respiratory insufficiency requiring treatment)
- Anastomotic leakage (clinically and amylase levels in drain fluid)
- Nutritional status (weight loss, intake)
- Need for parenteral feeding/ placement of a nasojejunal feeding tube
- Need for additional surgical, radiological or endoscopic interventions
- 30-day surgical complications (classified according to Clavien-Dindo)
- Other complications requiring treatment (i.e. urinary tract infection)
- Need for ICU admission and total length of ICU stay
- Quality of life
Background summary
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.
Study objective
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.
Study design
- 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
Intervention
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.
Gijs H.K. Berkelmans
P.O. Box 1350
Eindhoven 5623 EJ
The Netherlands
040-2397150
gijs.berkelmans@cze.nl
Gijs H.K. Berkelmans
P.O. Box 1350
Eindhoven 5623 EJ
The Netherlands
040-2397150
gijs.berkelmans@cze.nl
Inclusion criteria
- Patients that undergo a (minimally invasive) esophagectomy with intrathoracic anastomosis.
- written informed consent
- age >18 years
Exclusion criteria
- 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)
Design
Recruitment
IPD sharing statement
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 | NL4856 |
| NTR-old | NTR4972 |
| CCMO | NL52591.060.15 |
| OMON | NL-OMON42802 |