C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Main group One groupe in the study |
Diagnostic Test: C-reactive protein
C-reactive protein at postoperative days four and two.
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Outcome Measures
Primary Outcome Measures
- CRP_D4/CRP_D2 [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 [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.
Secondary Outcome Measures
- CRP_D4 [30 days after surgery]
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.
- CRP_D4 colorectal [30 days after surgery]
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.
- CRP_D2 [30 days after surgery]
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.
- CRP_D2 colorectal [30 days after surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Surgical resection for digestive cancer
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Creation of anastomosis.
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at least one measurement of CRP at the second and/or fourth postoperative day.
Exclusion Criteria:
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Surgical resection without anastomosis creation
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No measurement of CRP on the second or the fourth postoperative day.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institute of Oncology | Rabat | Morocco | 10090 |
Sponsors and Collaborators
- Moroccan Society of Surgery
Investigators
- Principal Investigator: Anass Majbar, MD, National Institute of Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRP_study