Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

Study Overview
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Brief Summary
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For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate improves postoperative recovery. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Detailed Description
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Studies show that avoiding long-time fasting by oral carbohydrates 2 hours before surgery attenuates discomfort and anxiety; it also reduces stress, insulin resistance and catabolism in patients undergoing gastrointestinal surgery, resulting in earlier recovery of gastrointestinal function and short length of hospital stay after surgery. However, for diabetic patients scheduled to undergo gastrointestinal surgery, the risks and benefits of preopertive oral carbohydrate remain unclear. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Official Title
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Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial

Conditions
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Gastrointestinal Surgery

Intervention / Treatment
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* Dietary Supplement: Oral carbohydrate (Outfast)
* Other: Routine fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years and beyond; Diagnosed with type 2 diabetes before surgery; Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more; Provide signed writen informed consents. Exclusion Criteria: Refuse to participate in the study; Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy; Previous history of total or partial gastrectomy; Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher; Preoperative pyloric and/or intestinal obstruction; Combined surgery on other intra-abdominal organs or other parts of the body.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. | Dietary Supplement: Oral carbohydrate (Outfast)<br>* For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated by an endocrinologist according to patients' daily glucose controlling plan. For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated is the same way as described above.<br>|
| Sham Comparator: Control group<br>For all patients, routine fasting (drinking water allowed) begins from 22:00 on the day before surgery， water fasting begins from 6:00 on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided from 6:00. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, magnesium sulfate) are added when becessary. | Other: Routine fasting<br>* For all patients, routine fasting (water drinking allowed) begin from 22:00 on the day before surgery until entering the operating room on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added in the 5% glucose (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, and magnesium sulfate) are added when considered necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of gastrointestinal function | Time to first flatus and defecation after surgery. | From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective feelings | Four subjective feelings, including the degree of being thirsty, hungry, tired and anxious, are assessed with Numeric Rating Scale (NRS, an 11-point scale where 0 = no feeling at all and 10 = the worst feeling). | Before anesthesia induction and at 4-6 hours after surgery. | 
| Blood glucose variation | Difference between the highest and the lowest blood glucose levels. | From 22:00 on the day before surgery until 24 hours after surgery. | 
| Insulin resistance (in part of patients) | Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation. | Assessed at 24 hours after surgery. | 
| Length of stay in hospital after surgery. | Length of stay in hospital after surgery. | From end of surgery until hospital discharge, up to 30 days after surgery. | 
| Incidence of postoperative complications | Postoperative complications are defined as newly occurred medical conditions that have harmful effects on patients' recovery and require therapeutic intervention. | From end of surgery until 30 days after surgery | 
| Time to first walking in the ground and distance of walking after surgery. | Time to first walking in the ground and distance of walking after surgery. | During the first 5 days after surgery | 
| All cause 30-day mortality | All cause 30-day mortality | At 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal surgery, Preoperative oral carbohydrate, Diabetic patients, Postoperative recovery