Carbohydrate Loading and Diabetes in Colorectal Surgery

University of Alberta

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Pre-operative carbohydrate drink

Study type: Interventional

Funder types: Other

Identifiers

NCT04410419

Carbs Drink in Colorectal

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Standard care for patients with diabetes pre-operatively .

Carbohydrate drink

Experimental group

Description:

Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

Treatment:

Dietary Supplement: Pre-operative carbohydrate drink