NCT02635503招募中3 期
A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2015年11月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Early morbidity rate
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
详细描述
Further study details as provided by Chinese Academy of Medical Sciences.
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 rectosigmoid (defined as 8- to 30-cm from the anal verge)
- •Pathological rectosigmoid adenocarcinoma
- •Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
- •Tumor size of 6 cm or less;
- •Eastern Cooperative Oncology Group (ECOG) score is 0-1
- •American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
- •Informed consent
排除标准
- •Body mass index (BMI) >30 kg/m2
- •Pregnant woman or lactating woman
- •Severe mental disease
- •Previous abdominal surgery
- •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
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
次要结局
- Duration of the intervention(1 day)
- Peritoneal bacterial contamination(1 day)
- Pain score(14 days)
- 3-year disease free survival rate(3 years)
- 5-year overall survival rate(5 years)
- Plasma levels of several cytokines after colorectal cancer surgery(7 days)
研究者
Zhixiang Zhou
director of Colorectal surgical Department
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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