C-Reactive ProteinNCT04133324
C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer
An observational study of C-Reactive Protein and Anastomotic Leak, run by Moroccan Society of Surgery at 1 site in Morocco.
Trial summary
The aim of this study is to investigate the diagnostic accuracy of the C Protein Reactive (CRP) for the detection of Anastomotic leakage after surgery for digestive cancer. The standard protocol in our unit is to measure the CRP on the second and fourth postoperative day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C-Reactive Protein, Anastomotic Leak, Digestive System Neoplasm
- What is being tested?
- C-reactive protein
- How many people
- 500 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Apr 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All consecutive patients who will undergo surgical resection for digestive cancer with the creation of anastomosis will be included. The standard protocol in our unit is to measure the CRP at the second and fourth postoperative days for early detection of anastomotic leakage. The following information will be recorded: age, gender, type of surgery, type of anastomosis, postoperative morbidity according to Clavien Grade, anastomotic leakage occurrence, infectious complications.
Who may be able to join
- Surgical resection for digestive cancer
- Creation of anastomosis.
- at least one measurement of CRP at the second and/or fourth postoperative day.
Who cannot join
- Surgical resection without anastomosis creation
- No measurement of CRP on the second or the fourth postoperative day.
Trial locations and contacts
1 site in 1 country.
Morocco1 site, 1 recruiting
- Recruiting
National Institute of Oncology
Rabat, 10090
Anass Majbar, MD, +2126688465673, anass.majbar@um5s.net.ma
About this study
Official title: Diagnosis Accuracy of the C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer
The aim of this study is to investigate the diagnostic accuracy of the C Protein Reactive (CRP) for the detection of Anastomotic leakage after surgery for digestive cancer. The standard protocol in our unit is to measure the CRP on the second and fourth postoperative day.
The main aim of the study is to investigate the diagnostic accuracy of the ratio CRP on the fourth postoperative day on CRP on the second postoperative day (CRP_D4/CRP_D2). Secondary outcomes are the diagnosis accuracy of the CRP_D4 and CRP_D2.
Read the detailed description
The occurrence of anastomotic fistula (AF) is the most feared complication after digestive cancer surgery. It is responsible for high morbidity and accounts for more than a third of the deaths observed. The rate of anastomotic fistula reported in the literature varies between 1 and 40% according to the definition chosen by the authors. In the literature, the occurrence of the anastomotic fistula is responsible for a mortality rate of 4% and an overall morbidity of 35%. In the short term, the anastomotic fistula can put the patient's vital prognosis at risk by its septic consequences. Also, it is responsible for increasing the length of stay and costs. In the longer term, anastomotic fistula affects the functional prognosis of the patient as well as oncology in patients operated for cancer.
Early rehabilitation becomes a standard in colorectal surgery, with exits around the 5th postoperative day. Anastomotic fistulas and their complications may appear well beyond. The diagnosis is made on average around 6-7 postoperative days. At an early stage, clinical signs are inconsistent and not very specific. Anastomotic fistula can manifest itself in a variety of clinical presentations, ranging from no symptoms to life-threatening septic shock. Routine imaging is neither reliable nor cost-effective for the detection of anastomotic fistulas and has the disadvantage of radiation.
It is necessary to find an intraperitoneal infection marker with a high negative predictive value. This is particularly important in the era of early rehabilitation, allowing for safe patient discharge with a low risk of readmission. C-reactive protein (CRP) has already shown its utility in the early detection of infections after digestive surgery, however, because of conflicting results, no clear recommendations are established in the literature.
Our study aims are to investigate the diagnostic accuracy of the postoperative CRP trajectory as an approach to eliminate the diagnosis of anastomotic fistula and to try to establish an optimal threshold with high sensitivity and negative predictive value.
- Being tested
- C-reactive protein
- Medical subject headings
- Anastomotic Leak, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-reactive proteinDiagnostic test
C-reactive protein at postoperative days four and two.
| Study group | Role | What they receive |
|---|---|---|
| Main group | One groupe in the study Receives: Diagnostic Test: C-reactive protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP_D4/CRP_D2
Diagnosis accuracy of the ratio CRP at the fourth on the second postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
Measured: 30 days after surgery
CRP_D4/CRP_D2 Colorectal
Diagnosis accuracy of the ratio CRP at the fourth on the second postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
Measured: 30 days after surgery
Secondary outcomes (4)
CRP_D4
Diagnosis accuracy of the ratio CRP at the fourth postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
Measured: 30 days after surgery
CRP_D4 colorectal
Diagnosis accuracy of the ratio CRP at the fourth postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
Measured: 30 days after surgery
CRP_D2
Diagnosis accuracy of the ratio CRP at the second postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
Measured: 30 days after surgery
CRP_D2 colorectal
Diagnosis accuracy of the ratio CRP at the second postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Apr 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C-Reactive ProteinStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anass Majbar, Moroccan Society of Surgery
- Investigators
- Anass Majbar, MD, Principal investigator, National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133324
- Sponsor's protocol ID
- CRP_study
- Status last verified
- Apr 2022
- First submitted
- 17 Oct 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Accuracy of the C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer
- ClinicalTrials.gov ID
- NCT04133324
- Acronym / sponsor ID
- CRP_study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Oct 2019 (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.
The aim of this study is to investigate the diagnostic accuracy of the C Protein Reactive (CRP) for the detection of Anastomotic leakage after surgery for digestive cancer. The standard protocol in our unit is to measure the CRP on the second and fourth postoperative day.
The main aim of the study is to investigate the diagnostic accuracy of the ratio CRP on the fourth postoperative day on CRP on the second postoperative day (CRP_D4/CRP_D2). Secondary outcomes are the diagnosis accuracy of the CRP_D4 and CRP_D2.
Detailed description
The occurrence of anastomotic fistula (AF) is the most feared complication after digestive cancer surgery. It is responsible for high morbidity and accounts for more than a third of the deaths observed. The rate of anastomotic fistula reported in the literature varies between 1 and 40% according to the definition chosen by the authors. In the literature, the occurrence of the anastomotic fistula is responsible for a mortality rate of 4% and an overall morbidity of 35%. In the short term, the anastomotic fistula can put the patient's vital prognosis at risk by its septic consequences. Also, it is responsible for increasing the length of stay and costs. In the longer term, anastomotic fistula affects the functional prognosis of the patient as well as oncology in patients operated for cancer.
Early rehabilitation becomes a standard in colorectal surgery, with exits around the 5th postoperative day. Anastomotic fistulas and their complications may appear well beyond. The diagnosis is made on average around 6-7 postoperative days. At an early stage, clinical signs are inconsistent and not very specific. Anastomotic fistula can manifest itself in a variety of clinical presentations, ranging from no symptoms to life-threatening septic shock. Routine imaging is neither reliable nor cost-effective for the detection of anastomotic fistulas and has the disadvantage of radiation.
It is necessary to find an intraperitoneal infection marker with a high negative predictive value. This is particularly important in the era of early rehabilitation, allowing for safe patient discharge with a low risk of readmission. C-reactive protein (CRP) has already shown its utility in the early detection of infections after digestive surgery, however, because of conflicting results, no clear recommendations are established in the literature.
Our study aims are to investigate the diagnostic accuracy of the postoperative CRP trajectory as an approach to eliminate the diagnosis of anastomotic fistula and to try to establish an optimal threshold with high sensitivity and negative predictive value.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | – | Diagnostic Test: C-reactive proteinOne groupe in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who will undergo surgical resection for digestive cancer with the creation of anastomosis will be included. The standard protocol in our unit is to measure the CRP at the second and fourth postoperative days for early detection of anastomotic leakage. The following information will be recorded: age, gender, type of surgery, type of anastomosis, postoperative morbidity according to Clavien Grade, anastomotic leakage occurrence, infectious complications.
Key inclusion criteria (3 listed)
- Surgical resection for digestive cancer
- Creation of anastomosis.
- at least one measurement of CRP at the second and/or fourth postoperative day.
Key exclusion criteria (2 listed)
- Surgical resection without anastomosis creation
- No measurement of CRP on the second or the fourth postoperative day.
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 |
|---|---|---|
| C-reactive proteinC-reactive protein at postoperative days four and two. | Diagnostic test | Main group |
Primary outcome
CRP_D4/CRP_D2
Time frame: 30 days after surgery
Diagnosis accuracy of the ratio CRP at the fourth on the second postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
CRP_D4/CRP_D2 Colorectal
Time frame: 30 days after surgery
Diagnosis accuracy of the ratio CRP at the fourth on the second postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.
4 secondary outcomes
CRP_D4
Time frame: 30 days after surgery
CRP_D4 colorectal
Time frame: 30 days after surgery
CRP_D2
Time frame: 30 days after surgery
CRP_D2 colorectal
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Anass Majbar, MD principal investigator
National Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C-Reactive Protein and Anastomotic Leak, run by Moroccan Society of Surgery at 1 site in Morocco.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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 Morocco. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anass Majbar, MD (+212668846573, anass.majbar@um5s.net.ma), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP_D4/CRP_D2 (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. 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 6 Apr 2022.