NCT01642953Unknown2 期
Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery
Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Drop rate from critical pathway
研究概览
简要总结
Study preparation
- To progress this prospective study, the investigators analyzed the retrospective data of 426 patients who had been managed with conventional critical pathway after gastric cancer surgery during last 1 year.
- Through this retrospective analysis, we decided the inclusion criteria which showed significantly the lower complication rate and shorter hospital stay.
Method for Prospective study
- Patients who enroll in this prospective study are administered and are supplied a liquid diet one day before surgery without bowel preparation.
- After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
详细描述
Enrollment of patients
- Before the patients are enrolled in this study, they give us informed consents.
- A liquid diet is supplied beginning from the morning of the day prior to operation to the midnight.
Operation and postoperative management
- All procedures are approached by laparoscopic surgery, and partial gastrectomy with lymph node dissection are performed.
- The patients who are considered to be difficult to progress early oral feeding in surgical field are excluded from the study.
- Nasogastric tube is not applied to patients.
- Postoperative pain is managed by non-opioid pain killer.
- The patients are started on sips of water on the first postoperative day.
- If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them.
- We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
Evaluation of patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with gastric adenocarcinoma
- •65 years old and blew
- •Patients are expected to be undergone distal subtotal gastrectomy
- •No complication by gastric cancer
- •No synchronous metastatic lesions
- •Laparoscopic or robotic surgery
- •Informed consent
排除标准
- •Previous gastrectomy history
- •Combined surgery due to synchronous malignancy
- •Patients with major organ dysfunction
结局指标
主要结局
Drop rate from critical pathway
时间窗: 4 days
It is defined as the proportion of dropped patients from 4 days critical pathway
次要结局
- Postoperative pain(7 days)
- Postoperative complication(30 days)
- Postoperative mortality(30 days)
- Recovery after surgery(7 days)
研究者
Hoon Hur
Assistant Professor
Ajou University School of Medicine
研究点 (2)
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