Clinical trial NCT04410419: Carbohydrate Loading and Diabetes in Colorectal Surgery
Official title: In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Surgery
Surgery--Complications
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean difference of preoperative glucose between the two groups
timeFrame: Pre-operative
Secondary outcomes:
measure: Composite outcome of diabetes-related complications
timeFrame: Within 30 days of surgery or to discharge
measure: length of stay
timeFrame: Within 30 days of surgery or to discharge
measure: Surgical site infection
timeFrame: Within 30 days of surgery or to discharge
measure: Postoperative complications using the Clavien Dindo scale
timeFrame: Within 30 days of surgery or to discharge
measure: Post-operative serum blood glucose concentration
timeFrame: Within 30 days of surgery or to discharge
measure: Rate of peri-operative insulin use
timeFrame: Within 30 days of surgery or to discharge
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References: