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

NCT05933408 | Completed

• 1 other identifier: TREM-1
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal (Colon or Rectal) Cancer

Keywords

colorectal; cancer; complications; infectious; TREM-1; marker

Outcome Measures

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

  first postoperative day

Secondary Outcomes (2)

• TREM-1 levels on the second postoperative day

  second postoperative day

• TREM-1 levels on the third postoperative day

  third postoperative day

Study Arms (2)

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

TREM-1 DIAGNOSTIC_TEST

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 with serious infectious complications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Location

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasms; Communicable Diseases

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: November 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)