Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

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The aim of this study is to provide conclusive clinical evidence as to whether or not the preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes of patients undergoing colorectal surgery.

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Detailed Description

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Preoperative oral carbohydrate loading is an issue that has been investigated extensively in terms of its fundamental and biochemically apparent effects and potential benefits. Most commonly, proponents of the application advocate that it may be beneficial for improving patient outcomes and for decreasing complication rate by attenuating postoperative insulin resistance. To date, however, no study with a sufficient sample size has been able to demonstrate that it has a marked value in clinical practice. Almost all of the clinical benefits ascribed to the application have been based on subjective well-being, which can also be provided with non specific simple beverages. A study conducted to show whether or not the application has direct influence on patient outcome, therefore, could significantly contribute insights on this topic. The present study was planned to consist of three study arms, namely: 1.Study group, which will be given high-carbohydrate beverage (Nutricia preOp®, Numico, Zoetermeer, The Netherlands) 2. Placebo group, which will be given flavored water, and 3. Control group (surgery after overnight fast). The revised power analysis shows that an accrual of 74 patients in each group would allow detecting a 15% difference in the rate of complications with 80% power at the 5% level of significance (two tailed). We hope we will have recruited at least 220 subjects at the end of a two-year course. Once the data recording is complete, this study will be the largest one ever conducted to investigate this topic.

Conditions

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Colorectal Disorders Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

High-carbohydrate

Group Type EXPERIMENTAL

commercially available high-carbohydrate beverage

Intervention Type DIETARY_SUPPLEMENT

800 ml before the day of surgery, and additional 400 ml two hours prior to surgery

2

Placebo

Group Type PLACEBO_COMPARATOR

flavored water

Intervention Type DIETARY_SUPPLEMENT

will be given in doses equal to those of high-carbohydrate beverage

3

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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commercially available high-carbohydrate beverage

800 ml before the day of surgery, and additional 400 ml two hours prior to surgery

Intervention Type DIETARY_SUPPLEMENT

flavored water

will be given in doses equal to those of high-carbohydrate beverage

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* patients undergoing colorectal surgery for malignant or benign diseases

Exclusion Criteria

* diabetes
* disorders that prolongs gastric emptying
* existence of an increased risk for aspiration of gastric content
* anal surgery (haemorrhoidectomy, fistulotomy...etc)
* emergency operations

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No