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

NCT07464600 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Colorectal Surgery
  • Enhanced Recovery
  • CRP Point-of-care Testing Trajectory
  • Post-operative Complication
  • Anastomotic Leak

Interventions

BIOLOGICAL

blood sample

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

BIOLOGICAL

Blood 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.

OTHER

Abdomino-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 & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2028-11-30
Completion
2029-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464600 on ClinicalTrials.gov