Amiens University Hospital
Amiens, 80480, France
Location status: Recruiting
NCT Number: NCT07464600
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amiens, 80480, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3.
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.
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.
Time frame: within 90 days
Time frame: within 90 days
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: 2 years
Time frame: 2 years
Pain will be assessed using the visual analog scale during the CRP POCT
Time frame: 2 years
Morbi-mortality according to Clavien-Dindo
Time frame: 2 years
Length of hospital stay
Time frame: 2 years
Unscheduled consultation rate
Time frame: 2 years
Unscheduled rehospitalization rate
Time frame: 2 years
Unscheduled reoperation rate
Time frame: 2 years
AL mortality according to Clavien-Dindo
Time frame: 2 years
AL related secondary stoma rate.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?
Acronym: CRP
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