Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- preoperative gastric residual volume of gastric fluid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Histologically confirmed gastric adenocarcinoma
- •Tumor of cT2-4aN0-2 in preoperative gastroscopy, endoscopic ultrasound, and/or abdominal computed tomography
- •Fit for elective radical resection
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •American Society of Anesthesiology (ASA) status I to III
- •Body mass index (BMI) of 17.5-27.5 kg/m2 .Patient agreed to participate this trial through informed consent.
排除标准
- •Symptoms of pyloric obstruction
- •Impaired bowel function, using drugs disturbing gastric secretion and gastric emptying
- •History of gastric resection
- •History of gastric cancer treatment
- •History of major abdominal operation, or diffuse peritonitis
- •Diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones
- •Potential difficult airway as evaluated by anesthesiologist
- •Pregnancy or breastfeeding were excluded in this trial .Patients would also be excluded if the following circumstances occurred: (1) failure of endotracheal intubation; (2) failure of intra-operative gastroscopy; or (3) irresectable tumor.
研究组 & 干预措施
Treatment group
Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery.
干预措施: preoperative oral carbohydrate drink (Dietary Supplement)
Control group
Patients undergo 6-8 hours of preoperative fasting.
结局指标
主要结局
preoperative gastric residual volume of gastric fluid
时间窗: 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.
次要结局
- Readmission rate within 30 days post operation(1 month after surgery)
- Reoperation rate within 30 days post operation(1 month after surgery)
- Preoperative PH of gastric fluid(20-30 minutes before the surgery)
- Preoperative thirsty/hungry scoring(1 hour before the surgery)
- Rate of perioperative complications(7-8 days)
- Recovery of bowel function(3-7 days)
- Perioperative insulin sensitivity(8 days)
- Length of hospital stay(2-3 weeks)
研究者
Dongjie Yang
Associate professor
First Affiliated Hospital, Sun Yat-Sen University