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临床试验/NCT04834011
NCT04834011Unknown不适用

Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) in Right-sided Colon Cancer: Surgical and Radiological Assessment. A Prospective Observational Study (RACOMERC)

University of Palermo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Preoperative radiologic assessment of patients with diagnosis of right-sided colon cancer. The investigators evaluated: fascia of Fredet; vascular structures (ileocolic vessels; right colic artery, middle colic artery, trunk of Henle); lymph nodes.

研究概览

简要总结

Colorectal surgery has made progressive advances in recent years related on one hand to the implementation of diagnostic methods that allow an early diagnosis of tumors and on the other hand to the development of therapeutic options based on laparoscopic surgery. In particular, multicenter clinical trials have shown that the laparoscopic approach to colorectal cancer had a comparable or even better outcomes in terms of perioperative complications and functional recovery of patients than traditional surgery. Complete Mesocolic Excision (CME) in right colonic resections is a surgical approach, of greater technical complexity, that appears to improve the oncological outcomes of these patients at the cost of an increased rate of complications. The highest rate of complications reported in the literature in patients undergoing CME was related to intraoperative bleeding due to the central vascular dissection that is performed. CT technological advances have made possible to perform CT angiography with multiplanar and three-dimensional reconstructions with the possibility of obtaining a detailed preoperative map of the vascular anatomy of these patients. CT scan was acquired immediately before contrast material injection and during arterial and venous phase. Arterial phase was obtained using the bolus tracking technique with an automated scan-triggering software. Image analysis was performed using multiplanar reformations (MPR), maximum intensity projection (MIP) and 3D volume rendering (VR) technique. The purpose of the CT was to identify three different parameters necessary for proper performance of CME and CVL and to compare preoperative observations with intraoperative evidence. All surgeries were performed by teams experienced in laparoscopic colorectal surgery. The investigators evaluated:- Fascia of Fredet; vascular structures; lymph nodes.

详细描述

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研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with diagnosis of right-sided colon cancer
  • patients underwent to CT angiography
  • laparoscopic right hemicolectomy with CME and CVL.

排除标准

  • metastatic disease
  • palliative treatment
  • impossibility to perform CT angiography
  • patients underwent to a traditional colonic resection with D2 lymphadenectomy.

结局指标

主要结局

Preoperative radiologic assessment of patients with diagnosis of right-sided colon cancer. The investigators evaluated: fascia of Fredet; vascular structures (ileocolic vessels; right colic artery, middle colic artery, trunk of Henle); lymph nodes.

时间窗: Evaluation of preoperative CT scan features during enrollment of patients.

Evaluation of preoperative CT scan features during enrollment of patients.

次要结局

  • Perioperative outcomes: intraoperative complications(intraoperative time)
  • Perioperative outcomes: postoperative complications(up to 30 days postoperative)
  • Perioperative outcomes: mean operative time(intraoperative time)
  • perioperative outcomes: rate of conversion(intraoperative time)

研究者

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

Prof. Antonino Agrusa

Associate professor

University of Palermo

研究点 (1)

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