Laparoscopic Versus Open Resection of Cancer Stomach
Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial
The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
There are two main types of techniques (open & laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin & less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision.
So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.
研究概览
详细说明
The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).
# Tumor resection;
Will be done by one of the following techniques:
- laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour)
Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1):
- D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of < 1.5 cm in diameter;
- D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer < 2.0 cm in diameter with only perigastric lymph node metastasis (N1);
- D2 for early cancer > 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Assiut、埃及
- Assiut university hospitals
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0).
Exclusion Criteria:
- Pregnancy.
- Infiltration to the( pancreas ,liver ,colon or vital vascular structure).
- Metastasis to the (liver, lung, brain, paraaortic LN involvement).
- Peritoneal deposit.
- Surgically unfit patient.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Laparoscopic gastrectomy
Patients allocated to the 'laparoscopic Gastrectomy' group will undergo laparoscopic gastrectomy.
If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one.
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Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.
其他名称：
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有源比较器：Open gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive gastrectomy via laparotomy.
This group is considered the control group
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patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy
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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 |
|---|---|---|
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The number of lymph nodes in the postoperative spicement.
大体时间：two weeks
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considered a prognostic factor for disease-free postoperative survival The more the number of lymph nodes the more radicality of the procesure
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two weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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死亡
大体时间：术后30天
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以 30 天死亡率衡量
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术后30天
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Postoperative complications
大体时间：Postoperatively with follow-up to one year
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Complications will be graded according to the Clavien-Dindo classification, which grades complications with regard to necessary treatment for this complication.
Also Long-term complications, such as hernia cicatricialis will be monitored
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Postoperatively with follow-up to one year
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Peri-operative blood loss
大体时间：during surgery, 1 day
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Laparoscopic gastrectomy is associated with less peri-operative blood loss.
Blood loss will be measured in milliliters and compared to the conventional 'open' group.
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during surgery, 1 day
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Duration of Surgery
大体时间：Peri-operatively, 1 day
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UsuallyLaparoscopic gastrectomy takes longer time to complete.
The duration of the procedure will be registered in minutes.
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Peri-operatively, 1 day
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合作者和调查者
调查人员
- 研究主任：Mostafa A Hamad, Prof.、Assiut University- Faculty of Medicine
- 研究主任：Mostafa M Sayed、Assiut University- Faculty of Medicine
- 首席研究员：Mohamed G Taher、Assiut University- Faculty of Medicine- General surgery department
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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