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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
University of Alberta Hospital
Edmonton, Alberta, Canada
Mean difference of preoperative glucose between the two groups
Examined in a non-inferiority fashion with NI margin set as 2mmol/L
Time frame: Pre-operative
Composite outcome of diabetes-related complications
hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration
Time frame: Within 30 days of surgery or to discharge
length of stay
How long the patient stays in hospital after surgery in days
Time frame: Within 30 days of surgery or to discharge
Surgical site infection
Whether a wound infection is noted in hospital
Time frame: 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.
Time frame: Within 30 days of surgery or to discharge
Post-operative serum blood glucose concentration
Serum blood glucose compiled on a daily basis
Time frame: 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
Time frame: Within 30 days of surgery or to discharge
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