About this trial
In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.
Disqualifiers
No anastomosis
Urgent surgery
Pregnancy or breast-feeding
Patients under guardianship or trusteeship
Trial design
Single group
Treatments tested in this trial
blood sample
Biological/VaccineBlood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3.
Blood taken from a fingertip
Biological/VaccineCRP POCT levels will be measured (from a drop of blood taken from a fingertip using a finger pricker) once the morning of surgery, the twice a day (morning and evening) after surgery of up to 5 days post-operatively, or until discharge if earlier.
Abdomino-pelvic CT scan
Other interventionAn abdomino-pelvic CT scan with rectal opacification will be proposed if blood CRP is \>150mg/l at D2 (2nd postoperative day) or if there is an increase of more than 50 mg/l in blood CRP between two consecutive samples.
Treatment groups
Trial outcomes
Primary outcomes
occurrence of an anastomotic fistula
Secondary outcomes
predictive character of AL of the trajectory of CRP POCT
The predictive character of AL of the trajectory of CRP POCT according to the type of anastomosis (ileo-colic, colo-colic, upper colorectal, lower colorectal)
Effective rate of antibiotic prescription
pain quantification
Pain will be assessed using the visual analog scale during the CRP POCT
Morbi-mortality rate
Morbi-mortality according to Clavien-Dindo
Sponsors and contacts
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