Colorectal SurgeryCRPNCT07464600
CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery
A study testing blood sample, Blood taken from a fingertip and Abdomino-pelvic CT scan in people with Colorectal Surgery and Enhanced Recovery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Enhanced Recovery, CRP Point-of-care Testing Trajectory
- What is being tested?
- blood sample, Blood taken from a fingertip and Abdomino-pelvic CT scan
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.
Who cannot join
- No anastomosis
- Urgent surgery
- Pregnancy or breast-feeding
- Patients under guardianship or trusteeship
- Minor patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, 80480
jean marc regimbeau, Pr, regimbeau.jean-marc@chu-amiens.fr
About this study
Official title: 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.
- Conditions
- Colorectal Surgery, Enhanced Recovery, CRP Point-of-care Testing Trajectory, Post-operative Complication, Anastomotic Leak
- Being tested
- blood sample, Blood taken from a fingertip, Abdomino-pelvic CT scan
- Keywords
- colorectal surgery, enhanced recovery, CRP point-of-care testing trajectory, post-operative complication, anastomotic leak
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
Blood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3.
Blood taken from a fingertipBiological
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 scanOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of an anastomotic fistula
Measured: within 90 days
Secondary outcomes (10)
predictive character of AL of the trajectory of CRP POCT
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)
Measured: within 90 days
Effective rate of antibiotic prescription
Measured: 2 years
pain quantification
Pain will be assessed using the visual analog scale during the CRP POCT
Measured: 2 years
Morbi-mortality rate
Morbi-mortality according to Clavien-Dindo
Measured: 2 years
Length of hospital stay
Length of hospital stay
Measured: 2 years
Unscheduled consultation rate
Unscheduled consultation rate
Measured: 2 years
Unscheduled rehospitalization rate
Unscheduled rehospitalization rate
Measured: 2 years
Unscheduled reoperation rate
Unscheduled reoperation rate
Measured: 2 years
AL mortality
AL mortality according to Clavien-Dindo
Measured: 2 years
AL related secondary stoma rate
AL related secondary stoma rate.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start17 Sep 2025
- Primary completionNov 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464600
- Sponsor's protocol ID
- PI2025_843_0154
- Acronym
- CRP
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?
- ClinicalTrials.gov ID
- NCT07464600
- Acronym / sponsor ID
- CRP / PI2025_843_0154
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.
Key exclusion criteria (5 listed)
- No anastomosis
- Urgent surgery
- Pregnancy or breast-feeding
- Patients under guardianship or trusteeship
- Minor patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleBlood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3. | Biological | – |
| Blood taken from a fingertipCRP 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. | Biological | – |
| Abdomino-pelvic CT scanAn 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. | Other | – |
Primary outcome
occurrence of an anastomotic fistula
Time frame: within 90 days
10 secondary outcomes
predictive character of AL of the trajectory of CRP POCT
Time frame: within 90 days
Effective rate of antibiotic prescription
Time frame: 2 years
pain quantification
Time frame: 2 years
Morbi-mortality rate
Time frame: 2 years
Length of hospital stay
Time frame: 2 years
Unscheduled consultation rate
Time frame: 2 years
Unscheduled rehospitalization rate
Time frame: 2 years
Unscheduled reoperation rate
Time frame: 2 years
AL mortality
Time frame: 2 years
AL related secondary stoma rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample, Blood taken from a fingertip and Abdomino-pelvic CT scan in people with Colorectal Surgery and Enhanced Recovery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Regimbeau, Pr (33+322 088 897, Regimbeau.jean-marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of an anastomotic fistula (time frame: within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.