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

March 6, 2026 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurrence of an anastomotic fistula
Time Frame: within 90 days
within 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 90 days
Effective rate of antibiotic prescription
Time Frame: 2 years
2 years
pain quantification
Time Frame: 2 years
Pain will be assessed using the visual analog scale during the CRP POCT
2 years
Morbi-mortality rate
Time Frame: 2 years
Morbi-mortality according to Clavien-Dindo
2 years
Length of hospital stay
Time Frame: 2 years
Length of hospital stay
2 years
Unscheduled consultation rate
Time Frame: 2 years
Unscheduled consultation rate
2 years
Unscheduled rehospitalization rate
Time Frame: 2 years
Unscheduled rehospitalization rate
2 years
Unscheduled reoperation rate
Time Frame: 2 years
Unscheduled reoperation rate
2 years
AL mortality
Time Frame: 2 years
AL mortality according to Clavien-Dindo
2 years
AL related secondary stoma rate
Time Frame: 2 years
AL related secondary stoma rate.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2025_843_0154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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