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Completed

NCT Number: NCT00134407

Postoperative Oral Intake Trial

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.

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Key information

Conditions

Postoperative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Northern Norway,

Tromsø, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal diet

Procedure

Nutrition via jejunal needle-catheter

Procedure

Primary outcomes

  1. Major complications within 8 weeks postoperatively

Secondary outcomes

  1. Minor complications

  2. Quality of Life

  3. Use of analgesics

  4. Post-laparotomy bowel movement

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2006
First posted
Aug 24, 2005
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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