Carbohydrate Loading and Diabetes in Colorectal Surgery

Overview

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.

Full Title of Study: “In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2020

Interventions

  • Dietary Supplement: Pre-operative carbohydrate drink
    • Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

Arms, Groups and Cohorts

  • No Intervention: Standard Care
    • Standard care for patients with diabetes pre-operatively .
  • Experimental: Carbohydrate drink
    • Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael Laffin, Investigator – University of Alberta

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