Infectious Complications After Colorectal Surgery Clinical Trial
— IMACORSOfficial title:
Comparison of C-reactive Protein and Procalcitonin to Detect Infectious Complications After Elective Colorectal Surgery
| Verified date | April 2017 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 552 |
| Est. completion date | July 2014 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Besançon | Besançon | |
| France | CGFL | Dijon | |
| France | CHU Dijon | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intraabdominal infection |