Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Study Overview
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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.

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.

Official Title
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Multi-centre Double-blind Randomized Trial of the Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery.

Conditions
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Colorectal Disorders, Colorectal Surgery

Intervention / Treatment
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* Dietary Supplement: commercially available high-carbohydrate beverage
* Dietary Supplement: flavored water


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>High-carbohydrate | Dietary Supplement: commercially available high-carbohydrate beverage<br>* 800 ml before the day of surgery, and additional 400 ml two hours prior to surgery<br>|
| Placebo Comparator: 2<br>Placebo | Dietary Supplement: flavored water<br>* will be given in doses equal to those of high-carbohydrate beverage<br>|
| No Intervention: 3<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall 30-day complication rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort |  | 2 years | 
| need for insulin infusion |  | 2 years | 
| Length of intensive care unit and hospital stay |  | 2 years | 
| Patient recovery |  | 2 years | 
| Overall 30-day mortality rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative care, colorectal surgery, carbohydrate, fasting