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

NCT ID: NCT03559335

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2021-05-15

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients after colorectal cancer surgery

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Achkasov Sergey

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State Scientific Centre of Coloproctology

Moscow, , Russia

Countries

Russia

References

Achkasov SI, Sukhina MA, Sushkov OI, Nabiev EN, Shakhmatov DG, Tarasov MA, Moskalev AI. [The role of neutrophil CD64 index in the diagnosis of infectious complications after colorectal resection]. Khirurgiia (Mosk). 2020;(10):29-35. doi: 10.17116/hirurgia202010129. Russian.

Reference Type: DERIVED

PMID: 33047583 (View on PubMed)

Other Identifiers

79

Identifier Type: -

Identifier Source: org_study_id