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
  Purpose

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.


Condition Intervention Phase
Postoperative Care
Procedure: Normal diet
Procedure: Nutrition via jejunal needle-catheter
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Postoperative Enteral Feeding or Early Oral Intake at Will. Effects on Clinical Outcome

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Major complications within 8 weeks postoperatively

Secondary Outcome Measures:
  • Minor complications
  • Quality of Life
  • Use of analgesics
  • Post-laparotomy bowel movement

Estimated Enrollment: 450
Study Start Date: February 2001
Estimated Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134407

Locations
Norway
University Hospital Northern Norway,
Tromsø,, Tromsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Investigators
Study Chair: Arthur Revhaug, Professor University of Northern Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00134407     History of Changes
Other Study ID Numbers: NFR 147339/320
Study First Received: August 22, 2005
Last Updated: September 2, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University Hospital of North Norway:
Nutrition
Postoperative
oral
jejunal
feeding
Surgery
major
abdominal
adult
postoperative

ClinicalTrials.gov processed this record on August 28, 2014