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NCT Number: NCT07464600

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, 80480, France

Location status: Recruiting

Location contact

jean marc regimbeau, Pr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

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

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.

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

    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)

  2. Effective rate of antibiotic prescription

    Time frame: 2 years

  3. pain quantification

    Time frame: 2 years

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

  4. Morbi-mortality rate

    Time frame: 2 years

    Morbi-mortality according to Clavien-Dindo

  5. Length of hospital stay

    Time frame: 2 years

    Length of hospital stay

  6. Unscheduled consultation rate

    Time frame: 2 years

    Unscheduled consultation rate

  7. Unscheduled rehospitalization rate

    Time frame: 2 years

    Unscheduled rehospitalization rate

  8. Unscheduled reoperation rate

    Time frame: 2 years

    Unscheduled reoperation rate

  9. AL mortality

    Time frame: 2 years

    AL mortality according to Clavien-Dindo

  10. AL related secondary stoma rate

    Time frame: 2 years

    AL related secondary stoma rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Marc Regimbeau, Pr

CONTACT

[email protected]

33+322 088 897

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?

Acronym: CRP

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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