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临床试验/NCT03426514
NCT03426514招募中不适用

Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2018年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
282
试验地点
1
主要终点
Early morbidity rate

研究概览

简要总结

This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer(TLSC) compared with conventional laparoscopic surgery for colorectal cancer(CLSC).

详细描述

At present,surgical treatments is the main means to cure colorectal cancer(CRC).The use of four or more ports has been routine in most laparoscopic colorectal resections. However,the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower,single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer(TLSC) have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.

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

  • Body mass index (BMI) <30 kg/m2
  • 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 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

排除标准

  • Previous gastrointestinal surgery
  • History of inflammatory bowel disease
  • History of familial adenomatous polyposis(FAP)
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Intolerance of surgery for severe comorbidities
  • 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 after surgery

morbidity rate 30 days after surgery

次要结局

  • Lymph node detection(14 days after surgery)
  • Postoperative recovery course(1-14 days after surgery)
  • Distal resection margin(14 days after surgery)
  • Proximal resection margin(14 days after surgery)
  • 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)
  • 5-year overall survival rate(60 months after surgery)
  • Operative time(intraoperative)
  • Intraoperative blood loss(intraoperative)

研究者

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

Zhao Ren

Chief Physicion

Ruijin Hospital

研究点 (1)

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