Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery
NCT ID: NCT04495114
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2017-08-31
2020-03-31
Brief Summary
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Traditionally, prior to surgeries involving 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.
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 to aspiration due to delayed gastric emptying.
Detailed Description
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Pre-operative fasting leads to insulin resistance and metabolic stresses. More recently it has been suggested that a preoperative carbohydrate loading may alleviate some deleterious effects of this fast. This strategy, combined with a number of others, have been recently introduced in many Enhanced Recovery After Surgery (ERAS) programs, that have led to improved postoperative pain, faster restoration of GI function, decreased LOS and decreased complication rate after colon surgery.
Type 2 diabetes is a disease of impaired glucose tolerance. It is a common condition that affects over 15% of general surgical patients undergoing major abdominal surgery. It is well recognized that this is a high-risk surgical population that is at increased risk of perioperative complications such as anastomotic dehiscence, poor wound healing, and postoperative ileus which can lead to an increased LOS after surgery. However, there is a relative dearth of robust evidence regarding preoperative fasting in patients with type 2 diabetes so there is no consensus among professional association guidelines internationally on recommendations for carbohydrate loading in this population undergoing elective surgery. Two major concerns have been raised; first the risk of aspiration in diabetic patients with a significant neuropathy and gastroparesis, and second potential for hyperglycemia and its deleterious effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Control Arm
Modern fasting guidelines without the carbohydrate load preoperatively.
No interventions assigned to this group
Intervention Arm
40g carbohydrate load preoperatively.
40g carbohydrate load (Apple juice)
A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.
Interventions
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40g carbohydrate load (Apple juice)
A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.
Eligibility Criteria
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Inclusion Criteria
* Elective colorectal surgery patient at the University of Alberta Hospital, Grey Nuns Hospital, Misericordia Hospital, Foothills Hospital, or Royal Alexandra Hospital.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Haili Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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RES0034025
Identifier Type: -
Identifier Source: org_study_id