Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Days of hospital stay after operation
研究概览
简要总结
The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
详细描述
Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:
- •Performed curative resection
- •Have The American Society of Anaesthesiologists (ASA) score of less than 3
排除标准
- •Patients who have simultaneously other cancer.
- •Patients who underwent gastric resection at past time.
- •Patients who have cancer with bleeding or perforation or obstruction.
- •Patients who have any injury to the pancreas capsule on operation.
- •Patients who get pregnancy.
- •Patients who are treating diabetics with Insulin.
结局指标
主要结局
Days of hospital stay after operation
时间窗: within 30 days after operation
We measure the length of hospital stay after operation
次要结局
- Day of recovery of bowel sound and flatus: Evidence of recovery of bowel sound by physician's examination and Evidence of first flatus by question to patient(within 30 days after operation)
- Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured(1,3,5 and 7 day after operation)
- Symptom of Patients: Question to patients about symptoms(before operation and 1,3,5,7 day after operation)
- Cost effectiveness: Total cost duration of hospitalization(within 30 days after admission)
- Quality of life: EORTC QLQ30, STO22(1,2 and 3 month after operation)
- Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA(before operation and 1,3,5,7 day after operation)
- Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol(within 30 days after operation)