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CompletedNCT05933408Updated Jul 7, 2023

TREM-1 - a New Marker of Serious Infectious Complications in Colorectal Surgery?

An observational study in Colorectal (Colon or Rectal) Cancer, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-07.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Colorectal (Colon or Rectal) Cancer

Keywords

  • colorectal
  • cancer
  • complications
  • infectious
  • TREM-1
  • marker
03

In context

Communicable Diseases

4,453 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's enrollment of 64 is below the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with serious infectious complications

    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).

    Diagnostic Test: TREM-1

  • Patients without complications

    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.

Interventions

  • Diagnostic testTREM-1

    The TREM-1 (triggering receptor expressed on myeloid cells-1) glycoprotein 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. Therefore the investigators aimed to investigate the potential use of soluble TREM-1 to predict serious infectious complications in patients undergoing laparoscopic colorectal surgery.Blood samples were drawn four times: on the day of surgery (preoperatively) and on the three following postoperative days (PODs).

06

What researchers measure

Primary outcomes

  1. TREM-1 levels on the first postoperative day

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

    Time frame: first postoperative day

Secondary outcomes

  1. TREM-1 levels on the second postoperative day

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

    Time frame: second postoperative day

  2. TREM-1 levels on the third postoperative day

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

    Time frame: third postoperative day

07

Study locations

1 site
  • Jagiellonian University Medical College
    Kraków, Małopolska 30-688, Poland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05933408
Lead sponsor
Jagiellonian University
Responsible party
Karolina Zawadzka (Medical Doctor, Principal Investigator, Jagiellonian University) — Principal investigator
First posted
Jul 6, 2023
Start date
Nov 1, 2018
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Last update
Jul 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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