Gastrointestinal Surgery
Conditions
Keywords
Gastrointestinal surgery, Preoperative oral carbohydrate, Diabetic patients, Postoperative recovery
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTOral carbohydrate (Outfast)
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.
OTHERRoutine fasting
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.
Sponsors
Dong-Xin Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor who perform postoperative follow-up is masked to group assignment.
Intervention model description
This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of 18 years and beyond; 2. Diagnosed with type 2 diabetes before surgery; 3. Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more; 4. Provide signed writen informed consents.
Exclusion criteria
1. Refuse to participate in the study; 2. Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy; 3. Previous history of total or partial gastrectomy; 4. 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; 5. Preoperative pyloric and/or intestinal obstruction; 6. Combined surgery on other intra-abdominal organs or other parts of the body.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of gastrointestinal function | From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery. | Time to first flatus and defecation after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose variation | From 22:00 on the day before surgery until 24 hours after surgery. | Difference between the highest and the lowest blood glucose levels. |
| Insulin resistance (in part of patients) | Assessed at 24 hours after surgery. | Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation. |
| Length of stay in hospital after surgery. | From end of surgery until hospital discharge, up to 30 days after surgery. | Length of stay in hospital after surgery. |
| Subjective feelings | Before anesthesia induction and at 4-6 hours after surgery. | 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 to first walking in the ground and distance of walking after surgery. | During the first 5 days after surgery | Time to first walking in the ground and distance of walking after surgery. |
| All cause 30-day mortality | At 30 days after surgery | All cause 30-day mortality |
| Incidence of postoperative complications | From end of surgery until 30 days after surgery | Postoperative complications are defined as newly occurred medical conditions that have harmful effects on patients' recovery and require therapeutic intervention. |
Countries
China
Outcome results
None listed