Inflammation Biomarkers in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03559335 |
|
Recruitment Status :
Completed
First Posted : June 18, 2018
Last Update Posted : September 22, 2021
|
Sponsor:
State Scientific Centre of Coloproctology, Russian Federation
Information provided by (Responsible Party):
Achkasov Sergey, State Scientific Centre of Coloproctology, Russian Federation
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|
| Colorectal Cancer |
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 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 : | January 15, 2018 |
| Actual Primary Completion Date : | January 15, 2020 |
| Actual Study Completion Date : | May 15, 2021 |
| Group/Cohort |
|---|
| Patients after colorectal cancer surgery |
Primary Outcome Measures :
- Postoperative inflammatory complications [ Time Frame: 30 days ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with colorectal cancer who undergo colorectal surgery at State Scientific Center of Coloproctology.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559335
Locations
| Russian Federation | |
| State Scientific Centre of Coloproctology | |
| Moscow, Russian Federation, 123423 | |
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | June 18, 2018 Key Record Dates |
| Last Update Posted: | September 22, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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, 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Disease Attributes Pathologic Processes |