Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Colorectal Cancer
- 发起方
- Ruijin Hospital
- 试验地点
- 1
- 主要终点
- Postoperative complications
- 状态
- 撤回
- 最后更新
- 4年前
概览
简要总结
This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
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.
研究者
入排标准
入选标准
- •Inclusion Criteria:
- •18 years \< age ≤85 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 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
- •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
Postoperative complications
时间窗: 30 days after surgery
Postoperative complications rate 30 days after surgery
次要结局
- Operative time(intraoperative)
- Intraoperative blood loss(intraoperative)
- Incision length(intraoperative)
- Length of stay(1-14 days after surgery)
- Pain score(1-3 days after surgery)
- 3-year disease free survival rate(36 months after surgery)
- Lymph node detection(14 days after surgery)
- 5-year overall survival rate(60 months after surgery)
- Incisal margin(14 days after surgery)
- Tumor size(14 days after surgery)
- Postoperative recovery course(1-14 days after surgery)