MedTrace Logo

Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

NCT01798511 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-09-26

No results posted yet for this study

Summary

Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.

Conditions

Interventions

PROCEDURE

Nasogastric Tube Feeding

A nasogastric tube will be placed into the stomach of patients.

OTHER

Conventional Nutritonal Management

Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case nasojejunal tube feeding will be introduced) or the signs of AP mitigate (in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced)

Sponsors & Collaborators

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Max Petrov, MD, MPH, PhD · University of Auckland, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2015-04-01
Completion
2020-04-01

Countries

  • New Zealand

Study Locations

More Related Trials

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 NCT01798511 on ClinicalTrials.gov