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临床试验/NCT04190589
NCT04190589招募中不适用

A Single Center Prospective Study Comparing Robot-assisted and Open Operation With Complete Mesocolic Excision (CME) in Extended Right Colectomy for Colon Cancer in the Right Flexure and Transverse Colon

Vejle Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年5月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Lymph node count

研究概览

简要总结

A single-center prospective study to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

详细描述

Complete mesocolic excision with central vascular ligation (CME) is an improvement of surgical technique in the operation for colonic cancer suggested to increase long-term survival. The concept was originally developed for open surgery by W. Hohenberger in Erlangen with excellent survival rates. However, if the tumor is located in the transverse colon or near the right colonic flexure, the procedure is particularly technically demanding, and for that reason most surgeons still prefer to do it by open operation (laparotomy) instead of the minimally invasive approach (laparoscopy) presently recommended for colonic cancer surgery. The advent of robotic surgery has improved the dexterity of instruments used in laparoscopic surgery and pushed the limits of what is possible with a minimally invasive approach. Since minimally invasive surgery is associated with better outcomes in terms of postoperative morbidity, pain, length of stay etc., it would be highly desirable if CME surgery could be done by robot-assisted laparoscopic operation instead of the current open approach. The current single-center study is proposed to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Suspected or verified colonic cancer visualized by colonoscopy and on CT in the anal part of the ascending colon, in the right flexure or in the oral 2/3 of the transverse colon
  • Patient is 18 years or older, legally competent and able to comprehend information and give consent
  • Tumor is UICC stage I-III on preop CT
  • Operation is elective

排除标准

  • Previous major open intraabdominal surgery
  • Ileus or other acute abdominal condition
  • CT scan with suspicion of T4 tumor
  • RITA score > 3 (Preop risk and frailty score)
  • BMI > 35 kg/m2
  • Project surgeon not available

研究组 & 干预措施

Robotic CME

Experimental

Robot-assisted extended right colectomy

干预措施: Robot-assisted laparoscopic extended right colectomy (Device)

结局指标

主要结局

Lymph node count

时间窗: 30 days

Number of nodes in specimen, as determined by pathologist

Plane of dissection

时间窗: 30 days

As judged by pathologist (mesocolic/intramesocolic/intramuscular)

次要结局

  • Reinterventions(30 days)
  • Complications(30 days)
  • Length of stay(30 days)
  • Readmissions(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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