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Clinical Trials/NCT03559335
NCT03559335
Completed
Not Applicable

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

State Scientific Centre of Coloproctology, Russian Federation1 site in 1 country100 target enrollmentJanuary 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
Enrollment
100
Locations
1
Primary Endpoint
Postoperative inflammatory complications
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
May 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
State Scientific Centre of Coloproctology, Russian Federation
Responsible Party
Principal Investigator
Principal Investigator

Achkasov Sergey

Professor Sc.State Scientific Centre of Coloproctology, Head of Surgical department of sugery and oncology of colon, Moscow,Russian Federation

State Scientific Centre of Coloproctology, Russian Federation

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative inflammatory complications

Time Frame: 30 days

Study Sites (1)

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