跳至主要内容
临床试验/NCT06540027
NCT06540027Enrolling By Invitation不适用

The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
1
主要终点
immune response

研究概览

简要总结

As a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. Although various prognostic studies on the relationship between gastrointestinal cancer types and SII (systemic inflammatory index) and the use of minimally invasive surgery have been published, the high level of this response and the type of surgery in the treatment of colorectal cancer have not yet been shown to have a direct effect on SII.

详细描述

Minimally invasive surgery has been demonstrated to significantly enhance the host immune response in colorectal cancer. The effect and the SII marker may be reliable indicators of this enhancement. A retrospective analysis was conducted on the records of patients who underwent surgery for colorectal cancer at our clinic over a four-year period. The patients were divided into three groups according to the surgical approach employed: open surgery, laparoscopic surgery and robotic surgery.

The primary outcome is: A comparison of the open surgery group with those undergoing minimally invasive surgery (laparoscopic and robotic) revealed lower SII values in the robotic surgery group than in the laparoscopic surgery group.

The secondary outcome : The SII values were determined as neutrophil/lymphocyte and platelet/lymphocyte, which had been previously investigated in other studies.

A comparison will be made with the relevant markers. The research team adheres to the principles set forth in the Declaration of Helsinki and Good Clinical Practice guidelines. They will conduct the study in an appropriate manner.

No intervention will be made in the follow-up and treatment of patients, in accordance with the approval of the hospital ethics committee.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients operated for rectal cancer
  • Open surgery
  • Laparoscopic surgery
  • Robotic surgery

排除标准

  • Patients with diagnosed immune deficiency
  • Patients with recurrent colorectal cancer
  • Patients with co-existent tumors

结局指标

主要结局

immune response

时间窗: 1 day

the level of SII

次要结局

未报告次要终点

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验