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Optimale voedingsroute na een oesofagusresectie

Nutritional Route In Esophageal Resection Trial II

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21339
Enrollment
148
Registered
2015-02-13
Start date
2015-04-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer, esophagectomy, nutrition, postoperative complications, pulmonary complications, anastomic leakage, Quality of life

Interventions

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.

Sponsors

Catharina Hospital Eindhoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients that undergo a (minimally invasive) esophagectomy with intrathoracic anastomosis. - written informed consent - age >18 years

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
- Functional recovery

Secondary

MeasureTime frame
- 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

Contacts

Public ContactGijs H.K. Berkelmans

Department of Surgery, Catharina Hospital

gijs.berkelmans@cze.nl040-2397150

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)