Postoperative Oral Intake Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

September 6, 2006

Start Date ^ICMJE

February 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Major complications within 8 weeks postoperatively

Original Primary Outcome Measures ^ICMJE

Complications major within 8 weeks postoperatively

Change History

Complete list of historical versions of study NCT00134407 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Minor complications
Quality of Life
Use of analgesics
Post-laparotomy bowel movement

Original Secondary Outcome Measures ^ICMJE

Complications minor
Quality of Life
Use of analgesics
Post-laparotomy bowel movement

Descriptive Information

Brief Title ^ICMJE

Postoperative Oral Intake Trial

Official Title ^ICMJE

Postoperative Enteral Feeding or Early Oral Intake at Will. Effects on Clinical Outcome

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Postoperative Care

Intervention ^ICMJE

Procedure: Normal diet
Procedure: Nutrition via jejunal needle-catheter

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00134407

Responsible Party

Study ID Numbers ^ICMJE

NFR 147339/320

Study Sponsor ^ICMJE

University Hospital of North Norway

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Arthur Revhaug, Professor

University of Northern Norway

Information Provided By

University Hospital of North Norway

Verification Date

September 2006

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