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Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery (POTLCAORCS)

2016年4月28日 更新者：Jian Suo

Affection on Anastomotic Blood Flow and the Lymph Nodes Dissection Between Division at the Root of the Inferior Mesenteric Artery and Preserving the Left Colic Artery in Rectum Cancer Surgery

To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will receive the radical resection of rectal carcinoma. We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis. Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA. Expecting Results：The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula. Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.

研究类型

介入性

注册 (实际的)

57

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Jilin
      • Changchun、Jilin、中国、130021
        • First Hospital of Jilin University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.
  • The rectum cancer is the first malignant neoplasm the patient has got.
  • The cancer is solitary, and is 3cm to 20cm to the anus.
  • The surgical method is limited to Dixon.

Exclusion Criteria:

  • Being in the acute phase of inflammation before operation and emergency surgery.
  • Patients receiving steroid medication or preoperative radiotherapy。
  • Discovering macrometastasis before or in the operation.
  • The rectum cancer that can't be radical resected.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：preserving the left colic artery
We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
程序：preserving the left colic artery
The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
实验性的：not preserving the left colic artery
We preserve the high ligation of the inferior mesenteric artery during the rectal surgery.
程序：not preserving the left colic artery
The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The Blood Pressure of the Arterial Arcade
大体时间：after ligating the inferior mesentric artery or superior rectal artery
after ligating the inferior mesentric artery or superior rectal artery

次要结果测量

结果测量
大体时间
Distal Colon Length
大体时间：after digestive tract reconstruction
after digestive tract reconstruction

其他结果措施

结果测量
大体时间
Systemic Blood Pressure
大体时间：after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon
after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jian Suo

调查人员

  • 学习椅：Jian Suo, Dr.、Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年2月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2014年10月1日

研究注册日期

首次提交

2013年10月25日

首先提交符合 QC 标准的

2013年11月7日

首次发布 (估计)

2013年11月8日

研究记录更新

最后更新发布 (估计)

2016年6月6日

上次提交的符合 QC 标准的更新

2016年4月28日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Left Colic Artery

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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