Postoperative Oral Intake Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00134407
First received: August 22, 2005
Last updated: September 2, 2011
Last verified: September 2011

August 22, 2005
September 2, 2011
February 2001
Not Provided
Major complications within 8 weeks postoperatively
Complications major within 8 weeks postoperatively
Complete list of historical versions of study NCT00134407 on ClinicalTrials.gov Archive Site
  • Minor complications
  • Quality of Life
  • Use of analgesics
  • Post-laparotomy bowel movement
  • Complications minor
  • Quality of Life
  • Use of analgesics
  • Post-laparotomy bowel movement
Not Provided
Not Provided
 
Postoperative Oral Intake Trial
Postoperative Enteral Feeding or Early Oral Intake at Will. Effects on Clinical Outcome

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Postoperative Care
  • Procedure: Normal diet
  • Procedure: Nutrition via jejunal needle-catheter
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
June 2006
Not Provided

Inclusion Criteria:

  • Adults subject to major, upper, open abdominal surgery (exceeding simple cholecystectomies and fundoplications)

Exclusion Criteria:

  • Crohns disease
  • Mentally disabled
  • Pre-op dependency on intravenous (IV) nutrition
  • Expected life duration of less than 3 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00134407
NFR 147339/320
Not Provided
University Hospital of North Norway
University Hospital of North Norway
Not Provided
Study Chair: Arthur Revhaug, Professor University of Northern Norway
University Hospital of North Norway
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP