Postoperative Oral Intake Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Care

Intervention / Treatment
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* Procedure: Normal diet
* Procedure: Nutrition via jejunal needle-catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Normal diet|nan|
|Procedure: Nutrition via jejunal needle-catheter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications within 8 weeks postoperatively |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor complications |  |  | 
| Quality of Life |  |  | 
| Use of analgesics |  |  | 
| Post-laparotomy bowel movement |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Postoperative, oral, jejunal, feeding, Surgery, major, abdominal, adult