Efficacy and Safety of Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pulmonary function
研究概览
简要总结
This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.
详细描述
The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.
排除标准
- •Neoadjuvant therapy;Surgical contraindication.
研究组 & 干预措施
gasless single-port laparoscopic surgery
radical resection of rectal carcinoma is performed by gasless single-port laparoscopic-assisted surgery.
干预措施: gasless single-port laparoscopic surgery (Procedure)
conventional laparoscopic surgery
radical resection of rectal carcinoma is performed by conventional laparoscopic surgery.
干预措施: conventional laparoscopic surgery (Procedure)
结局指标
主要结局
Pulmonary function
时间窗: Change from baseline PaO2/FiO2 ratio 10 minutes after the surgery is over.
Estimate the pulmonary function in the perioperational period by blood gas analysis, which will be compared with comparator.The main parameter partial pressure of oxygen(PaO2)/inspired oxygen fraction(FiO2) ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.
Immunologic function
时间窗: Change from baseline CD4/CD8 ratio 7 days after operation.
Estimate the immunologic function in the perioperational period by blood lymphocyte analysis, which will be compared with comparator.The main parameter cluster of differentiation 4(CD4)/cluster of differentiation 8(CD8) ratio is the ratio of lymphocyte CD4 numbers to lymphocyte CD8 numbers.
次要结局
- Number of the lymph node dissection(at 1 week after operation)
- Operation time(at 1 day)
- Postoperative pain(72 hours after operation)
- Bowel function(up to 1 week after operation)