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临床试验/NCT03826446
NCT03826446已完成不适用

Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer

Menoufia University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon

研究概览

简要总结

Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon.The aim of this study was to compare between laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.

详细描述

Colorectal cancer incidence and mortality rates vary markedly around the world. Globally, colorectal cancer is the third most commonly diagnosed cancer in males and the second in females, with 1.65 million new cases and almost 835,000 deaths in 2015. Rates are substantially higher in males than in females.

The right colon has a large caliber, a thin wall, and its contents are liquid; thus, obstruction is a late event. Bleeding is usually occult. Fatigue and weakness caused by severe anemia may be the only complaints. Tumors sometimes grow large enough to be palpable through the abdominal wall before other symptoms appear.

Curative treatment for right colon cancer includes resection of the tumor-bearing bowel segment. There are standard types of operations, depending on the location of the tumor. The types of standard resections are based on the knowledge of lymphatic drainage and lymph node anatomy.

Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon. In 2009, Hohenberger, a German scholar, proposed the term of complete mesocolic excision (CME), whose basic theory is mainly composed of two concepts in fetal anatomy and surgical oncology: sharp dissection of the mesocolic plane and the parietal plane. CME helps to keep the colonic mesentery intact, clarify the dissected area from central lymph nodes, emphasize the importance of transecting colon-feeding blood at the root, and increase the range of longitudinal enterotomy. Thus, CME provides a standardization of surgeries for colon cancer.

Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery..

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only operable cases of right colon cancer by (CT scan criteria) which include:
  • No permeation of surrounding fat planes.
  • No encasement of major vascular structures.
  • No extensive local spread.
  • No distant metastases or peritoneal infiltration were included in this study.

排除标准

  • 1- All cases with perforation or obstruction. 2- Metastatic colon cancer. 3- Patients undergoing colectomy including another part of the colon than right colon.

研究组 & 干预措施

Open Surgery

Other

Patients diagnosed as operable right sided colon cancer were enrolled in this study and did open complete mesocolic excision procedures

干预措施: Surgery (Procedure)

Laparoscopic Surgery

Other

Patients diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic complete mesocolic excision procedures

干预措施: Surgery (Procedure)

结局指标

主要结局

Incision length in open and laparoscopic complete mesocolic excision groups in right cancer colon

时间窗: 1-3 years

Comparing the incision length between laparoscopic and open complete mesocolic excision with central artery ligation groups

Histopathological findings in open and laparoscopic complete mesocolic excision groups in right cancer colon

时间窗: 1-3 years

Comparing the histopathological findings between laparoscopic and open complete mesocolic excision with central artery ligation groups

Post-operative complications in open and laparoscopic complete mesocolic excision groups in right cancer colon

时间窗: 1-3 years

Comparing the post-operative complications between laparoscopic and open complete mesocolic excision with central artery ligation groups

Operative time in open and laparoscopic complete mesocolic excision groups in right cancer colon

时间窗: 1-3 years

Comparing the operative time between laparoscopic and open complete mesocolic excision with central artery ligation groups

Hospital stay duration in open and laparoscopic complete mesocolic excision groups in right cancer colon

时间窗: 1-3

Comparing the hospital stay duration between laparoscopic and open complete mesocolic excision with central artery ligation groups

Recurrence rate in open and laparoscopic complete mesocolic excision groups in right cancer colon

时间窗: 1-3 years

Comparing the recurrence rate between laparoscopic and open complete mesocolic excision with central artery ligation groups

次要结局

未报告次要终点

研究者

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

Karim Mohamed Shady

kshady- Principal investigstor

Menoufia University

研究点 (2)

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