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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

NCT01642875 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-11-23

No results posted yet for this study

Summary

Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial.

The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

Conditions

Interventions

OTHER

Enteral nutrition

Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.

OTHER

Oral nutrition

Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Maciej Słodkowski, MD · Medical University of Warsaw

  • Marek Wronski, MD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01642875 on ClinicalTrials.gov