Clinical trial · Interventional
Nutritional Route In Esophageal Resection Trial II
Nutritional Route in Esophageal Resection Trial II (NUTRIENT II): a Randomized Controlled Trial
NCT02378948CI-TRIAL-00036846NUTRIENTIIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate the effects of early start versus delayed start of oral intake on postoperative functional recovery after an esophagectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid oral feeding | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early oral feeding
- description
- Liquid oral feeding directly after esophagectomy.
- interventionNames
- Dietary Supplement: Liquid oral feeding
- type
- NO_INTERVENTION
- label
- Delayed oral feeding
- description
- Liquid oral feeding 5 days after esophagectomy
Primary outcomes (1)
- measure
- Functional recovery
- timeFrame
- up to 4 weeks after surgery
- description
- The primary outcome parameter is the day of functional recovery. Functional recovery is defined as postoperative patients who are free of IV fluid, have adequate pain control, restoration of mobility to an independent level, have sufficient caloric intake and no signs of active infection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDBerkelmans GH, Wilts BJ, Kouwenhoven EA, Kumagai K, Nilsson M, Weijs TJ, Nieuwenhuijzen GA, van Det MJ, Luyer MD. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial. BMJ Open. 2016 Aug 5;6(8):e011979. doi: 10.1136/bmjopen-2016-011979. PMID 27496239