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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Tromsø
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Tromsø,, Tromsø, Norway, 9038
- University Hospital Northern Norway,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Major complications within 8 weeks postoperatively
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Secondary Outcome Measures
Outcome Measure |
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Quality of Life
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Minor complications
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Use of analgesics
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Post-laparotomy bowel movement
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Collaborators and Investigators
Investigators
- Study Chair: Arthur Revhaug, Professor, University of Northern Norway
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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