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临床试验/NCT03696472
NCT03696472Unknown不适用

Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV

Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
2
试验地点
1
主要终点
5-years overall survival rate

研究概览

简要总结

The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection.

Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated

详细描述

Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2

排除标准

  • With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy

研究组 & 干预措施

robotic-assisted left colonic resection

Experimental

Standard left colonic resection assisted by Davinci Robotic

干预措施: robotic assisted surgery (Procedure)

laparoscopic left colonic resection

Active Comparator

Standard laparoscopic left colonic resection

干预措施: laparoscopic (Procedure)

结局指标

主要结局

5-years overall survival rate

时间窗: 5 years

次要结局

  • Anastomosis leakage rate(6 months)
  • Short-term morbidity rate(30 days)
  • Complication incident rate of surgery(1 day)
  • Blood loss during operation(1 day)
  • Operation Time(1 day)
  • C-reaction protein level(7 days)
  • Recovery time after surgery(60 days)

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Chuan

Secretary of General Surgery

Southwest Hospital, China

研究点 (1)

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