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Postoperative Oral Intake Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134407
First Posted: August 24, 2005
Last Update Posted: September 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital of North Norway
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Postoperative Enteral Feeding or Early Oral Intake at Will. Effects on Clinical Outcome

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00134407     History of Changes
Other Study ID Numbers: NFR 147339/320
First Submitted: August 22, 2005
First Posted: August 24, 2005
Last Update Posted: September 5, 2011
Last Verified: September 2011

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