Postoperative Oral Intake Trial

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134407

Enrollment

450

Registered

2005-08-24

Start date

2001-02-28

Completion date

2006-06-30

Last updated

2011-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Care

Keywords

Nutrition, Postoperative, oral, jejunal, feeding, Surgery, major, abdominal, adult

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.

Interventions

PROCEDURENormal diet

PROCEDURENutrition via jejunal needle-catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Major complications within 8 weeks postoperatively	—

Secondary

Measure	Time frame
Minor complications	—
Quality of Life	—
Use of analgesics	—
Post-laparotomy bowel movement	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026