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临床试验/NCT02635503
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhixiang Zhou

director of Colorectal surgical Department

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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