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Inflammatory Markers After COloRectal Surgery) (IMACORS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510314
First Posted: January 16, 2012
Last Update Posted: April 14, 2017
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.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  Purpose

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.


Condition Intervention
Infectious Complications After Colorectal Surgery Biological: C-reactive protein and procalcitonin dosages

Study Type: Interventional
Official Title: Comparison of C-reactive Protein and Procalcitonin to Detect Infectious Complications After Elective Colorectal Surgery

Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Intraabdominal infection

Enrollment: 552
Actual Study Start Date: November 2011
Study Completion Date: July 2014
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01510314


Locations
France
CHU Besançon
Besançon, France, 25030
CGFL
Dijon, France, 21079
CHU Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Pablo Ortega-Deballon Centre Hospitalier Universitaire Dijon
  More Information

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01510314     History of Changes
Other Study ID Numbers: ORTEGA GGEST 2011
First Submitted: January 13, 2012
First Posted: January 16, 2012
Last Update Posted: April 14, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Communicable Diseases
Infection
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs