Preoperative Carbohydrate Loading in Elective Surgery

Study Overview
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Brief Summary
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Postoperative infectious morbidity remain the most frequent, threatening and costly event after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent such complications and given the preliminary data on the positive effect of carbohydrate load on glucose metabolism it might also be valuable in improving outcome. If this treatment will be proved effective on relevant outcome measure such as rate of infections, it might be used routinely and extensively because preoperative carbohydrates administration is cheap, simple and applicable by everyone in any surgical ward. The aim of the trial is to evaluate if the normalization of blood glucose by means of preoperative oral administration of maltodextrine, in patients candidate to elective major surgery, may be effective in improve surgical morbidity.

Official Title
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PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS

Conditions
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Surgery

Intervention / Treatment
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* Dietary Supplement: PREOP
* Other: water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients candidate for elective major (expected duration > 2 hrs) abdominal, urologic, and gynecologic surgery Exclusion Criteria: diagnosis of diabetes mellitus, baseline plasma glucose level > 125 mg/dl, pancreatic resection, ASA score > 3, malnutrition (loss of weight greater than 10%), emergency surgery, documented gastro-esophageal reflux, corticosteroid therapy, ongoing infection, pregnancy, age < 18 years, denied written informed consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative carbohydrate loading<br>Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia | Dietary Supplement: PREOP<br>* a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL<br>|
| Placebo Comparator: water<br>The control group will receive plain water with the same volume and timing of treatment. | Other: water<br>* The control group will receive plain water with the same volume and timing of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of postoperative complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients needing insulin treatment |  | 4 days | 
| rate of total complications |  | 30 day after surgery | 
| rate of patients needing antibiotic therapy |  | 30 days after surgery | 
| rate of reopaeration |  | 15 days | 
| rate of patients needing intensive care treatment |  | 15 days | 
| length of hospital stay |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrate, glucose metabolism, surgery, outcome, major elective surgery, urology, hyperglicemia