Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05933408 |
| Other study ID # |
TREM-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
February 28, 2020 |
Study information
| Verified date |
July 2023 |
| Source |
Jagiellonian University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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).
Since 2012, in our department the perioperative care of all patients is carried out based on
the ERAS protocol and laparoscopic approach has been the gold standard in colorectal surgery
at our center.
