Anastomotic Leak, Colorectal Surgery, CRP Point-of-care Testing Trajectory, Enhanced Recovery, Post-operative Complication
Conditions
Keywords
colorectal surgery, enhanced recovery, CRP point-of-care testing trajectory, post-operative complication, anastomotic leak
Brief summary
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.
Interventions
BIOLOGICALblood sample
Blood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3.
BIOLOGICALBlood taken from a fingertip
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.
OTHERAbdomino-pelvic CT scan
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.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.
Exclusion criteria
* No anastomosis * Urgent surgery * Pregnancy or breast-feeding * Patients under guardianship or trusteeship * Minor patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of an anastomotic fistula | within 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain quantification | 2 years | Pain will be assessed using the visual analog scale during the CRP POCT |
| Morbi-mortality rate | 2 years | Morbi-mortality according to Clavien-Dindo |
| Length of hospital stay | 2 years | Length of hospital stay |
| Unscheduled consultation rate | 2 years | Unscheduled consultation rate |
| Unscheduled rehospitalization rate | 2 years | Unscheduled rehospitalization rate |
| Unscheduled reoperation rate | 2 years | Unscheduled reoperation rate |
| AL mortality | 2 years | AL mortality according to Clavien-Dindo |
| predictive character of AL of the trajectory of CRP POCT | 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) |
| AL related secondary stoma rate | 2 years | AL related secondary stoma rate. |
| Effective rate of antibiotic prescription | 2 years | — |
Countries
France
Contacts
CONTACTJean-Marc Regimbeau, Pr
Outcome results
None listed