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Postoperative Oral Intake Trial

U

University Hospital of North Norway

Status and phase

Completed
Phase 1

Conditions

Postoperative Care

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00134407
NFR 147339/320

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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