The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
NCT Number: NCT02815150
This study aims to assess the impact of preoperative oral carbohydrate drink on gastric emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore, investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate in elective gastric cancer surgery, providing direct evidence for clinical practice.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely applied in elective colorectal surgery. However, no direct evidence has been showed that whether it is safe to do so in gastric cancer patients who are fit for elective radical gastric resection.
This study aims to discuss the impact and safety of oral administration of 5% glucose solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study, which refers to a single-center, prospective, single blind, and randomized controlled study design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the study, who will be allocated into control or treatment group. Patients in control group follow the traditional routine of 6-8 hours preoperative fasting, while those in the treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The primary end-point is the preoperative gastric residual volume. The secondary end-points include preoperative PH of gastric fluid, assessment of perioperative psychosomatic conditions, rate of perioperative complications, level of insulin sensitivity, recovery of bowel function, and the length of hospital stay, etc.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5% glucose solution 250ml 2-3 hours before surgery
Time frame: 20-30 minutes before the surgery
After anesthesia induction with 100-120mg propofol and 0.5 mg/kg rocuronium bromide and tracheal intubation, keep the patient in left lateral decubitus position. Insert the gastroscope ( Olympus 260) and perform complete suction of gastric fluid under direct vision with the suction apparatus connecting to the sterile airtight collector. Measure the volume of the gastric fluid in collector with a cylindrical measuring cup, accurate to 0.1ml. Repeat it and then take an average.
Time frame: 20-30 minutes before the surgery
bromide and tracheal intubation, keep the patient in left lateral decubitus position. Insert the gastroscope ( Olympus 260) and perform complete suction of gastric fluid under direct vision with the suction apparatus connecting to the sterile airtight collector. Inject 1ml clear gastric fluid into a vacuum drying tube by syringe and detect the PH value with the Delta 320 PH Detector twice and calculate the average value.
Time frame: 1 hour before the surgery
Visual analogue scale with the score 0-10, 0 the least, 10 the most
Time frame: 7-8 days
Including surgery-specific complications, such as bleeding, anastomosis leakage, and non-surgery-specific ones, such as lung infection, urinary tract infection, etc.
Time frame: 3-7 days
Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet
Time frame: 8 days
Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ [ log ( I0) + log (G0) ],I0 is the fasting insulin value, G0 is the fasting blood glucose value。
Time frame: 2-3 weeks
Post operative hospital stay
Time frame: 1 month after surgery
Readmission for any reason within 30 days after the surgery.
Time frame: 1 month after surgery
Reoperation that happens within 30 days after the primary surgery.
First Affiliated Hospital, Sun Yat-Sen University
Other
Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection
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