Carbohydrate Loading and Diabetes in Colorectal Surgery

Study Overview
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Brief Summary
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The goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes. Traditionally, prior to surgeries involving a general anesthetic, patients have been told not to eat or drink anything after midnight due to the risk of aspiration. More recent research have shown that it is safe to have clear fluids up to 2 hours before an operation and this is reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that subjecting patients to a state of starvation causes stress on the body that may lead to complications such as poor wound healing, infections, and delayed return to bowel function. A sugar drink before surgery has been shown to be beneficial and can lead to decreased complication rates and decreased length of stay after surgery. However, it is currently not known if it is safe for patients with type 2 diabetes to have a sugar drink before their surgery since they have trouble processing sugars and a subset of patients with diabetes are at increased risk of aspiration due to delayed stomach emptying. This feasibility study is designed to answer the question of whether a large scale trial can be conducted examining the benefits of a pre-operative sugar drink in patients with type 2 diabetes.

Official Title
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In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial

Conditions
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Surgery, Diabetes Mellitus, Type 2, Surgery--Complications

Intervention / Treatment
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* Dietary Supplement: Pre-operative carbohydrate drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult (>=18 years of age) patients with an established diagnosis of type 2 diabetes mellitus undergoing elective colorectal surgery at the University of Alberta Hospital, the Grey Nuns Hospital, the Royal Alexandra Hospital or the Misericordia Hospital will be eligible. Only patients treated with diet or oral hypoglycemic agents will be included. Exclusion Criteria: Subjects <18 years of age, and those on insulin therapy preoperatively will be excluded.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Standard care for patients with diabetes pre-operatively . | |
| Experimental: Carbohydrate drink<br>Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery | Dietary Supplement: Pre-operative carbohydrate drink<br>* Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference of preoperative glucose between the two groups | Examined in a non-inferiority fashion with NI margin set as 2mmol/L | Pre-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of diabetes-related complications | hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration | Within 30 days of surgery or to discharge | 
| length of stay | How long the patient stays in hospital after surgery in days | Within 30 days of surgery or to discharge | 
| Surgical site infection | Whether a wound infection is noted in hospital | Within 30 days of surgery or to discharge | 
| Postoperative complications using the Clavien Dindo scale | A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5. | Within 30 days of surgery or to discharge | 
| Post-operative serum blood glucose concentration | Serum blood glucose compiled on a daily basis | Within 30 days of surgery or to discharge | 
| Rate of peri-operative insulin use | Whether insulin or an insulin infusion in the peri-operative period is used | Within 30 days of surgery or to discharge |