Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Early morbidity rate
研究概览
简要总结
Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.
详细描述
The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.
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
- 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
- •18 years < age < 80 years
- •Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
- •Pathological colorectal carcinoma
- •Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual
- •Tumor size of 5 cm or less
- •ECOG score is 0-1
- •ASA score is Ⅰ-Ⅲ
- •Informed consent
排除标准
- •Body mass index (BMI) >30 kg/m2
- •The lower border of the tumor is located distal to the peritoneal reflection
- •Pregnant woman or lactating woman
- •Severe mental disease
- •Previous abdominal surgery（except appendectomy and cholecystotomy）
- •Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- •Requirement of simultaneous surgery for other disease
结局指标
主要结局
Early morbidity rate
时间窗: 30 days
morbidity rate 30 days after surgery
次要结局
- 5-year overall survival rate(60 months after surgery)
- 3-year disease free survival rate(36 months after surgery)
- Tumor size(14 days after surgery)
- Lymph node detection(14 days after surgery)
- Operative time(intraoperative)
- Intraoperative blood loss(intraoperative)
- Incision length(intraoperative)
- Incisal margin(14 days after surgery)
- Length of stay(1-14 days after surgery)
- Postoperative recovery course(1-14 days after surgery)
- Pain score(1-3 days after surgery)