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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
65
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.
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.
Peking University First Hospital
Beijing, Beijing Municipality, China
Recovery of gastrointestinal function
Time to first flatus and defecation after surgery.
Time frame: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.
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).
Time frame: Before anesthesia induction and at 4-6 hours after surgery.
Blood glucose variation
Difference between the highest and the lowest blood glucose levels.
Time frame: 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.
Time frame: Assessed at 24 hours after surgery.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Time frame: 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.
Time frame: From end of surgery until 30 days after surgery
Time to first walking in the ground and distance of walking after surgery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to first walking in the ground and distance of walking after surgery.
Time frame: During the first 5 days after surgery
All cause 30-day mortality
All cause 30-day mortality
Time frame: At 30 days after surgery