Compared With Robotic-assisted and Laparoscopic-assisted Gastrectomy for Gastric Cancer on Surgical,Clinical and Oncological Outcomes
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 主要终点
- Five-year disease free survival rate
研究概览
简要总结
The study aims to compare the clinical outcomes between robotic-assisted and laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who are more suitable for robotic gastrectomy.
详细描述
This is a prospective study lasting 36 months.
Minimally invasive gastrectomy is accepted widely in Asian countries. Laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.The advantages of robotic surgery include a 3D imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability.
This study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(RAG) using the da Vinci Surgical System and conventional laparoscopic-assisted gastrectomy(LAG) in gastric cancer patients.To evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Pathologically proven gastric cancer(early or advanced).
- •Age:older than 18 years old,younger than 80 years old.
- •cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition
- •No obvious surgical contraindications.
- •American Society of Anesthesiology (ASA) score class I, II, or III
- •Written informed consent.
排除标准
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
- •History of unstable angina or myocardial infarction within past six months
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of other malignant disease within past 5 years.
- •Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- •Any accompanying surgical condition needed to be performed in the same time
结局指标
主要结局
Five-year disease free survival rate
时间窗: Up to 5 years post-operative
次要结局
- Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay)(7 days)
- Mortality(30 days)
- Operating time(1 day)
- Intraoperative situation (The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion)(1 day)
- Complication (score based on the Clavien-Dindo classification system)(30 days)
- Hospitalization expenses(30 days)
- Quality of life(Up to 5 years post-operative)
- Five-year overall survival rate(Up to 5 years post-operative)
- Readmissions and recurrence rate(Up to 5 years post-operative)
研究者
wei bo
Vice Director of the general surgery department, Chinese PLA General Hospital
Chinese PLA General Hospital