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

NCT07464600 | Recruiting

• 1 other identifier: PI2025_843_0154
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

colorectal surgery; enhanced recovery; CRP point-of-care testing trajectory; post-operative complication; anastomotic leak

Outcome Measures

Primary Outcomes (1)

• occurrence of an anastomotic fistula

  within 90 days

Secondary Outcomes (10)

• predictive character of AL of the trajectory of CRP POCT

  within 90 days

• Effective rate of antibiotic prescription

  2 years

• pain quantification

  2 years

• Morbi-mortality rate

  2 years

• Length of hospital stay

  2 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.

You may not qualify if:

• No anastomosis
• Urgent surgery
• Pregnancy or breast-feeding
• Patients under guardianship or trusteeship
• Minor patients

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens University Hospital

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jean-Marc Regimbeau, Pr

CONTACT

33+322 088 897; Regimbeau.jean-marc@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: March 11, 2026
• Study Start: September 17, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)