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
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
研究组 & 干预措施
transrectal specimen extraction
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
干预措施: transrectal specimen extraction (Procedure)
Conventional laparoscopic surgery
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
干预措施: Conventional laparoscopic surgery (Procedure)
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
- Pain score(14 days)
- Duration of the intervention(1 day)
- Peritoneal bacterial contamination(1 day)
- 3-year disease free survival rate(3 years)
- Plasma levels of several cytokines after colorectal cancer surgery(7 days)
- 5-year overall survival rate(5 years)
研究者
Zhixiang Zhou
director of Colorectal surgical Department
Cancer Institute and Hospital, Chinese Academy of Medical Sciences