Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 710
- 试验地点
- 12
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.
详细描述
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years < age ≤85 years
- •Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
- •Pathological or highly suspected colorectal carcinoma
- •Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th 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) >35 kg/m2
- •The lower border of the tumor is located distal to the peritoneal reflection
- •Familial adenomatous polyposis (FAP)
- •Inflammatory bowel disease (IBD)
- •Multiple malignant colorectal tumors
- •Pregnant woman or lactating woman
- •Severe mental disease
- •Previous gastrointestinal surgery (except appendectomy ）
- •Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- •Requirement of simultaneous surgery for other disease
- •Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months after surgery
3-year disease free survival rate
次要结局
- Operative time(intraoperative)
- Incision length(intraoperative)
- Intraoperative blood loss(intraoperative)
- Total incision length(intraoperative)
- Conversion rate(intraoperative)
- Early morbidity rate(30 days after surgery)
- Lymph node detection(14 days after surgery)
- Length of stay(1-14 days after surgery)
- Tumor size(14 days after surgery)
- Cosmetic effect(1 month, 6 months and 1 year after surgery)
- The quality of life-Colorectal(1 month, 6 months and 1 year after surgery)
- Postoperative recovery course(1-14 days after surgery)
- Pain score(1-3 days after surgery)
- Incisal margin(14 days after surgery)
- The quality of life-Core(1 month, 6 months and 1 year after surgery)
- 5-year overall survival rate(60 months after surgery)