Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134407
Status:
COMPLETED
Last Update Posted:
2011-09-05
First Post:
2005-08-22
Brief Title:
Postoperative Oral Intake Trial
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Postoperative Enteral Feeding or Early Oral Intake at Will Effects on Clinical Outcome
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Complete fasting until resumed bowel function after upper abdominal surgery is not beneficial Enteral feeding has been claimed to be the preferred way of delivering nutritional support postoperatively Increasing evidence suggests that letting patients eat voluntary oral feeding or oral intake at will from the day after the operation is safe No prospective randomised trial has been undertaken to compare these two regimens In this study the investigators will randomise 444 patients subject to major upper abdominal surgery into receiving either continuous enteral feeding by needle catheter jejunostomy until resumed bowel function or to oral intake at will from postoperative day 1 The main endpoints are the incidence rate of major complications and death as well as a Quality of Life assessment
Null-Hypothesis
Routine postoperative feeding by needle catheter jejunostomy after major upper abdominal surgery has no clinically relevant advantages over early oral intake at will
Null-Hypothesis
Routine postoperative feeding by needle catheter jejunostomy after major upper abdominal surgery has no clinically relevant advantages over early oral intake at will
Detailed Description:
Complete fasting until resumed bowel function after upper abdominal surgery is not beneficial Enteral feeding has been claimed to be the preferred way of delivering nutritional support postoperatively Increasing evidence suggests that letting patients eat voluntary oral feeding or oral intake at will from the day after the operation is safe No prospective randomised trial has been undertaken to compare these two regimens In this study we will randomise 444 patients subject to major upper abdominal surgery into receiving either continuous enteral feeding by needle catheter jejunostomy until resumed bowel function or to oral intake at will from postoperative day 1 The main endpoints are the incidence rate of major complications and death as well as a Quality of Life assessment
Null-Hypothesis
Routine postoperative feeding by needle catheter jejunostomy after major upper abdominal surgery has no clinically relevant advantages over early oral intake at will
Null-Hypothesis
Routine postoperative feeding by needle catheter jejunostomy after major upper abdominal surgery has no clinically relevant advantages over early oral intake at will
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None