跳至主要内容
临床试验/NCT05933408
NCT05933408已完成不适用

Is Triggering Receptor Expressed On Myeloid Cells 1 (TREM-1) Protein a New Marker of Serious Infectious Complications in Colorectal Surgery? - Case-matched Pilot Study

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
TREM-1 levels on the first postoperative day

研究概览

简要总结

The aim of this study is to investigate the potential use of soluble TREM-1 (sTREM-1) to predict serious infectious complications in patients undergoing laparoscopic colorectal surgery. Patients with colon or rectal cancer, who underwent elective laparoscopic colorectal cancer surgery between November 2018 and February 2020 were included into study. Blood samples for the TREM-1 protein assay were collected from each patient four times: preoperatively and on three following postoperative days (PODs).

Patients with infectious complications who formed group 1, were matched 1:1 with patients without complications (group 2). Case-matched analysis was performed by selecting patients for the control group from the group of patients paired by age, ASA scale, stage of cancer and type of surgery.

详细描述

The TREM-1 (triggering receptor expressed on myeloid cells-1) glycoprotein, which belongs to the immunoglobulin superfamily, is a receptor involved in the activation of monocytes and neutrophils during the inflammatory process. There are many reports indicating the soluble form of this receptor is a reliable diagnostic marker of infection and inflammatory response induced by trauma [9, 10]. TREM-1 has been described as a mean to assess the risk of the occurrence of infections in some surgical conditions, but no one has studied its application in predicting complications in patients who underwent elective laparoscopic resection of colorectal cancer [11, 12]. Therefore, the investigators set out to investigate the potential use of soluble TREM-1 (sTREM-1) to predict serious infectious complications in patients undergoing laparoscopic colorectal surgery.

Patients with colon or rectal cancer, who underwent elective laparoscopic colorectal cancer surgery between November 2018 and February 2020 were included into study. Blood samples for the TREM-1 protein assay were collected from each patient four times: preoperatively and on three following postoperative days (PODs).

Clinical data and demographic information of patients (age, sex, comorbidities, ASA (American Society of Anaesthesiologists) physical status) were prospectively collected on database. After the surgery, the database was supplemented with data related to the procedure (type of surgery, operative time, intraoperative blood loss) and treatment results (complication, length of hospital stay (LOS)).

Patients with infectious complications who formed group 1, were matched 1:1 with patients without complications (group 2). Case-matched analysis was performed by selecting patients for the control group from the group of patients paired by age, ASA scale, stage of cancer and type of surgery.

Complications were graded according to the five grade Clavien-Dindo classification (CD 1-5). Complications have been divided into mild (CD 1-2) and severe (CD 3-5).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • adult patients (>18 y/o) with histopathologically confirmed colorectal adenocarcinoma who underwent laparoscopic resection of the colon and/or rectum

排除标准

  • open or emergency surgery,
  • multivisceral resection
  • stage IV cancer according to American Joint Committee on Cancer (AJCC) classification system
  • concomitant inflammatory bowel disease
  • autoimmune systemic disease
  • other active infection
  • when conversion to open resection was necessary

结局指标

主要结局

TREM-1 levels on the first postoperative day

时间窗: first postoperative day

TREM-1 levels on the first day after surgery in patients with and without infectious complications

次要结局

  • TREM-1 levels on the second postoperative day(second postoperative day)
  • TREM-1 levels on the third postoperative day(third postoperative day)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karolina Zawadzka

Medical Doctor, Principal Investigator

Jagiellonian University

研究点 (1)

Loading locations...

相似试验