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| Sponsored by: |
University Hospital of North Norway |
|---|---|
| Information provided by: | University Hospital of North Norway |
| ClinicalTrials.gov Identifier: | NCT00134407 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Care |
Procedure: Normal diet Procedure: Nutrition via jejunal needle-catheter |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| Official Title: | Postoperative Enteral Feeding or Early Oral Intake at Will. Effects on Clinical Outcome |
| Estimated Enrollment: | 450 |
| Study Start Date: | February 2001 |
| Estimated Study Completion Date: | June 2006 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway, Tromsø | |
| University Hospital Northern Norway, | |
| Tromsø,, Tromsø, Norway, 9038 | |
| Study Chair: | Arthur Revhaug, Professor | University of Northern Norway |
More Information
| Study ID Numbers: | NFR 147339/320 |
| Study First Received: | August 22, 2005 |
| Last Updated: | September 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00134407 History of Changes |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
Nutrition Postoperative oral jejunal feeding |
Surgery major abdominal adult postoperative |
