Clinical trial NCT00134407: Postoperative Oral Intake Trial
Official title: Postoperative Enteral Feeding or Early Oral Intake at Will. Effects on Clinical Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Care
Keywords: Nutrition
Postoperative
oral
jejunal
feeding
Surgery
major
abdominal
adult
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2005-08-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major complications within 8 weeks postoperatively
Secondary outcomes:
measure: Minor complications
measure: Quality of Life
measure: Use of analgesics
measure: Post-laparotomy bowel movement
Other outcomes:
Locations:
city: Tromsø,
country: Norway
facility: University Hospital Northern Norway,
state: Tromsø
Study officials:
affiliation: University of Northern Norway
name: Arthur Revhaug, Professor
role: STUDY_CHAIR
References: