Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07464600

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-03-11

500

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of C-reactive protein (CRP) point-of-care testing (POCT) to predict early anastomotic leak (AL) in patients undergoing elective colorectal surgery. AL is a serious complication where a surgical connection leaks, and early diagnosis before symptoms appear could improve patient outcomes. The study aims to evaluate how the trajectory of CRP levels measured by POCT compares to standard blood testing for detecting AL risk and improving post-operative care. Participants will have their CRP levels monitored using both standard blood samples taken on days 2 and 3 after surgery and finger-prick CRP POCT performed before surgery and twice daily for up to five days post-operatively or until discharge. If blood CRP levels rise above certain thresholds, an abdomino-pelvic CT scan with rectal opacification will be offered to assess for possible complications. This study observes how these testing methods may reduce the number of blood samples needed and speed up medical responses. During the study, patients will be monitored for the occurrence of anastomotic fistula within 90 days after surgery. Researchers will also track antibiotic use, pain levels, hospital stay length, unscheduled visits or hospitalizations, reoperations, and mortality related to AL over two years. The study includes ongoing assessments and safety monitoring to understand how CRP POCT may support early rehabilitation and better outcomes after colorectal surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy
  • Adults aged 18 years and older
Not Eligible

You will not qualify if you...

  • No anastomosis during surgery
  • Urgent or emergency surgery
  • Pregnant or breastfeeding individuals
  • Patients under guardianship or trusteeship
  • Minors (under 18 years old)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 5 days or until discharge

Participants undergo elective colorectal surgery. Blood CRP levels are measured by a finger prick once the morning of surgery and twice daily (morning and evening) for up to 5 days post-operatively or until discharge if earlier.

Up to 11 visits (in-person) including the morning of surgery and twice daily post-surgery

Post-operative Follow-up

Duration - 3 days post-surgery

Blood CRP levels are measured by standard blood sampling on the 2nd and 3rd postoperative days. An abdomino-pelvic CT scan with rectal opacification may be proposed if blood CRP is above specified thresholds to check for anastomotic complications.

2 visits (in-person) for blood sampling; additional CT scan visit if indicated

Trial Site Locations

Total: 1 location

1

Amiens University Hospital

Amiens, France, 80480

Actively Recruiting

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Research Team

J

Jean-Marc Regimbeau, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

0

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