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Inflammation Biomarkers in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery

WBC Count, CRP, PCT, Neutrophil CD64 and Monocyte Human Leukocyte Antigen- DR Expression in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03559335
Enrollment
100
Registered
2018-06-18
Start date
2018-01-15
Completion date
2021-05-15
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Biomarkers, Neutrophil CD64, Monocyte Human Leukocyte Antigen - DR, Postoperative Infectious Complications, C-reactive protein (CRP), Procalcitonin (PCT)

Brief summary

This is a longitudinal, single-center, prospective study to determine the efficiency of WBC Count, CRP, PCT, Neutrophil CD64 and Monocyte Human Leukocyte Antigen- DR in the diagnosis of postoperative infectious complications in colorectal cancer surgery

Detailed description

Blood samples for inflammation markers are carried out from patients with сolorectal cancer surgery in a single center on the day of the surgery in the operating room before intravenous fluid application started. Each patient receives systemic antibiotic prophylaxis for gramnegative and anaerobic bacteria on induction of anesthesia and prior to skin incision. A standardized protocol for general and epidural anesthesia is used. Values of WBC count, CRP, PCT, CD64n and HLA-DR monocyte are recorded before surgery and after surgery on POD (postoperative day) 1, 3 and 6 or 7. SIRS criteria on POD 1, 3, 6 or 7 and postoperative infections up to 30 days after surgery are recorded. SSIs (incisional, organ / space), pneumonia, central venous catheter related bloodstream infections (CRBSIs), urinary tract infections (UTIs) and enterocolitis records are taken. Microbial cultures are using as the gold standard. Criteria for SIRS reconsidered in the year 2001 by SCCM / ESICM / ACCP / ATS / SIS International Sepsis Definitions Conference and criteria for Dosage Control and Prevention (CDC) are taken into consideration. After discharge, each patient is being monitored by outpatient clinic examinations. The study will recruit approximately 100 patients during three consecutive years.

Interventions

None listed

Sponsors

State Scientific Centre of Coloproctology, Russian Federation
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Have a elective colorectal resection for colorectal cancer * Have signed approved informed consent form for the study

Exclusion criteria

* Significant simultaneous surgical procedure (e.g., liver resection of metastasis) * Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery * Neo-adjuvant chemotherapy and/or radiotherapy * Autoimmune conditions * Inflammatory bowel diseases

Design outcomes

Primary

MeasureTime frame
Postoperative inflammatory complications30 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026