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

Sponsor
State Scientific Centre of Coloproctology, Russian Federation (Other)
Overall Status
Completed
CT.gov ID
NCT03559335
Collaborator
(none)
100
Enrollment
1
Location
40
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    WBC Count, CRP, PCT, Neutrophil CD64 and Monocyte Human Leukocyte Antigen- DR Expression in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery
    Actual Study Start Date :
    Jan 15, 2018
    Actual Primary Completion Date :
    Jan 15, 2020
    Actual Study Completion Date :
    May 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patients after colorectal cancer surgery

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative inflammatory complications [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 State Scientific Centre of Coloproctology Moscow Russian Federation 123423

    Sponsors and Collaborators

    • State Scientific Centre of Coloproctology, Russian Federation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    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
    ClinicalTrials.gov Identifier:
    NCT03559335
    Other Study ID Numbers:
    • 79
    First Posted:
    Jun 18, 2018
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 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
    Colorectal cancer
    Biomarkers
    Neutrophil CD64
    Monocyte Human Leukocyte Antigen - DR
    Postoperative Infectious Complications
    C-reactive protein (CRP)
    Procalcitonin (PCT)
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Sep 22, 2021