TREM-1 - a New Marker of Serious Infectious Complications in Colorectal Surgery?
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Małopolska
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Kraków, Małopolska, Poland, 30-688
- Jagiellonian University Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients (>18 y/o) with histopathologically confirmed colorectal adenocarcinoma who underwent laparoscopic resection of the colon and/or rectum
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
|
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).
|
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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TREM-1 levels on the first postoperative day
Time Frame: first postoperative day
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TREM-1 levels on the first day after surgery in patients with and without infectious complications
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first postoperative day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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TREM-1 levels on the second postoperative day
Time Frame: second postoperative day
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TREM-1 levels on the second day after surgery in patients with and without infectious complications
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second postoperative day
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TREM-1 levels on the third postoperative day
Time Frame: third postoperative day
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TREM-1 levels on the third day after surgery in patients with and without infectious complications
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third postoperative day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TREM-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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