Inflammatory Markers After COloRectal Surgery) (IMACORS)
Primary Purpose
Infectious Complications After Colorectal Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
C-reactive protein and procalcitonin dosages
Sponsored by
About this trial
This is an interventional trial for Infectious Complications After Colorectal Surgery
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing elective colorectal surgery with anastomosis for benign or malignant disease
- > 18 years old
- Giving written informed consent
- Included in the national health insurance
Exclusion Criteria:
- Emergent surgery
- Previous infection
- Patients undergoing Hyperthermic Intraperitoneal Chemotherapy
- Pregnancy
Sites / Locations
- CHU Besançon
- CGFL
- CHU Dijon
Outcomes
Primary Outcome Measures
Intraabdominal infection
Secondary Outcome Measures
Full Information
NCT ID
NCT01510314
First Posted
January 13, 2012
Last Updated
April 13, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT01510314
Brief Title
Inflammatory Markers After COloRectal Surgery)
Acronym
IMACORS
Official Title
Comparison of C-reactive Protein and Procalcitonin to Detect Infectious Complications After Elective Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
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Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas the efficacy of treatment depends on early diagnosis. By detecting such complications early it could be possible to reduce their severity, the length of hospitalisation, repeat colostomy and the number of readmissions. Our team has shown that C-reactive protein (CRP) > 125 mg/L at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a marker of sepsis currently used in intensive care, but its use in the follow-up of elective surgery, particularly colorectal surgery, has not been fully evaluated.
The aim of this study is to compare the ability of CRP and PCT to detect SC as early as postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC) after elective colorectal surgery.
Adult patients about to undergo elective colorectal surgery with anastomosis will be included once they have given their written informed consent. Levels of CRP and PCT will be measured the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging examinations will be performed at the discretion of the surgeon; the only obligation will be to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 > 125 mg/L with no other clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary to show the superiority of PCT over CRP in clinical terms and with regard to the cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Complications After Colorectal Surgery
7. Study Design
Study Phase
Not Applicable
Enrollment
552 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
C-reactive protein and procalcitonin dosages
Primary Outcome Measure Information:
Title
Intraabdominal infection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing elective colorectal surgery with anastomosis for benign or malignant disease
> 18 years old
Giving written informed consent
Included in the national health insurance
Exclusion Criteria:
Emergent surgery
Previous infection
Patients undergoing Hyperthermic Intraperitoneal Chemotherapy
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Ortega-Deballon
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CGFL
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
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Inflammatory Markers After COloRectal Surgery)
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