CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • blood sample

    Biological/Vaccine

    Blood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3.

  • Blood taken from a fingertip

    Biological/Vaccine

    CRP 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 intervention

    An 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

occurrence of an anastomotic fistula

Time frame
within 90 days

Secondary outcomes

1

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)

Time frame
within 90 days
2

Effective rate of antibiotic prescription

Time frame
2 years
3

pain quantification

Pain will be assessed using the visual analog scale during the CRP POCT

Time frame
2 years
4

Morbi-mortality rate

Morbi-mortality according to Clavien-Dindo

Time frame
2 years

Other outcomes

Sponsors and contacts

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