Early Recovery After Gastric Cancer Surgery
2012年7月18日 更新者：Hoon Hur、Ajou University School of Medicine
Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery
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.
研究概览
详细说明
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
- The patients are followed up to 30 days after discharge from hospital, and we check whether they are tolerable without any compliant and are readmitted.
研究类型
介入性
注册 (预期的)
109
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Suwon、大韩民国、443-721
- 招聘中
- Ajou University Hospital
-
接触：
- Hoon Hur, prof.
- 电话号码：+82-31-219-5200
- 邮箱：hhcmc75@naver.com
-
接触：
- Sang-Uk Han, prof.
- 电话号码：+82-31-219-5200
- 邮箱：hansu@ajou.ac.kr
-
副研究员：
- Sang-Uk Han, Professor
-
副研究员：
- Cheul Soo Byun, Instructor
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 65年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous gastrectomy history
- Combined surgery due to synchronous malignancy
- Patients with major organ dysfunction
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Early recovery
Patients who enroll in this arm 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. |
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Drop rate from critical pathway
大体时间：4 days
|
It is defined as the proportion of dropped patients from 4 days critical pathway
|
4 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain
大体时间：7 days
|
It is defined as the change of pain scale after surgery
|
7 days
|
|
Postoperative complication
大体时间：30 days
|
It is defined the complications after surgery
|
30 days
|
|
Postoperative mortality
大体时间：30 days
|
It will defined as the death case during 30 days after surgery
|
30 days
|
|
Recovery after surgery
大体时间：7 days
|
It is defined as the time to first flatus and recovery of bowel activity after surgery
|
7 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hoon Hur, Prof.、Ajou University School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年7月1日
初级完成 (预期的)
2014年7月1日
研究完成 (预期的)
2014年8月1日
研究注册日期
首次提交
2012年7月14日
首先提交符合 QC 标准的
2012年7月16日
首次发布 (估计)
2012年7月17日
研究记录更新
最后更新发布 (估计)
2012年7月20日
上次提交的符合 QC 标准的更新
2012年7月18日
最后验证
2012年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.