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Optimale voedingsroute na een oesofagusresectie


- candidate number21684
- NTR NumberNTR4972
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-feb-2015
- Secondary IDsNL52591.060.15 
- Public TitleOptimale voedingsroute na een oesofagusresectie
- Scientific TitleNutritional Route In Esophageal Resection Trial II
- ACRONYMNUTRIENT II
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Oesophagectomy, Nutrition, Quality of life
- 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)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate31-dec-2016
- Target number of participants148
- InterventionsEarly 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.
- Primary outcome- Pulmonary complications (Pneumonia, Acute respiratory distress syndrome (ARDS), respiratory insufficiency requiring treatment)
- Secondary outcome- Functional recovery - Anastomotic leakage (clinically and amylase levels in drain fluid) - Nutritional status (weight loss, sarcopenia, 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
- Timepoints- Pulmonary complications: within 30 days after surgery. - Anastomotic leakage: within 30 days after surgery by clinical/radiological signs or confirmed by reoperation. - Nutritional status: Daily calculation of caloric and protein intake until 14 days postoperatively. - Quality of life: preoperatively, 3 months, 6 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Gijs H.K. Berkelmans
- CONTACT for SCIENTIFIC QUERIES Misha Luyer
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven,
- Publications1 Weijs TJ, Berkelmans GH, Nieuwenhuijzen GA, et al. Routes for early enteral nutrition after esophagectomy. A systematic review. Clin Nutr 2015; 34(1): 1-6.
- Brief summaryThe 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.
- Main changes (audit trail)21-okt-2015:

Primary outcome NEW:
Functional recovery

Secondary outcomes NEW:
- 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

Timepoints NEW:
- 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
- RECORD13-feb-2015 - 21-okt-2015


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