NCT03559335

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

June 6, 2018

Last Update Submit

September 21, 2021

Conditions

Colorectal Cancer

Keywords

Colorectal cancerBiomarkersNeutrophil CD64Monocyte Human Leukocyte Antigen - DRPostoperative Infectious ComplicationsC-reactive protein (CRP)Procalcitonin (PCT)

Outcome Measures

Primary Outcomes (1)

  • Postoperative inflammatory complications

    30 days

Study Arms (1)

Patients after colorectal cancer surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with colorectal cancer who undergo colorectal surgery at State Scientific Center of Coloproctology.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

Related Publications (1)

  • 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.

    PMID: 33047583DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Sc.State Scientific Centre of Coloproctology, Head of Surgical department of sugery and oncology of colon, Moscow,Russian Federation

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

January 15, 2018

Primary Completion

January 15, 2020

Study Completion

May 15, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)