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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | Standard care for patients with diabetes pre-operatively . | |
| Carbohydrate drink | Experimental | Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative carbohydrate drink | Dietary Supplement | Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D004700 | Endocrine System Diseases |