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| Name | Class |
|---|---|
| The First Affiliated Hospital of the Fourth Military Medical University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery. |
|
| Control group | No Intervention | Patients undergo 6-8 hours of preoperative fasting. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative oral carbohydrate drink | Dietary Supplement | 5% glucose solution 250ml 2-3 hours before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| preoperative gastric residual volume of gastric fluid | 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. | 20-30 minutes before the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative PH of gastric fluid | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongjie Yang | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 20-30 minutes before the surgery |
| Preoperative thirsty/hungry scoring | Visual analogue scale with the score 0-10, 0 the least, 10 the most | 1 hour before the surgery |
| Rate of perioperative complications | Including surgery-specific complications, such as bleeding, anastomosis leakage, and non-surgery-specific ones, such as lung infection, urinary tract infection, etc. | 7-8 days |
| Recovery of bowel function | Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet | 3-7 days |
| Perioperative insulin sensitivity | Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ [ log ( I0) + log (G0) ]，I0 is the fasting insulin value, G0 is the fasting blood glucose value。 | 8 days |
| Length of hospital stay | Post operative hospital stay | 2-3 weeks |
| Readmission rate within 30 days post operation | Readmission for any reason within 30 days after the surgery. | 1 month after surgery |
| Reoperation rate within 30 days post operation | Reoperation that happens within 30 days after the primary surgery. | 1 month after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |