NCT01798511

Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Auckland, New Zealand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Acute Pancreatitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2020-04-01
• First posted: 2013-02-26
• Last updated: 2019-09-26

Locations

1 site across 1 country: New Zealand