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Role of Procalcitonin, C-Reactive Protein, and WBC Count in Prediction of Colorectal Anastomotic Leak

A Prospective Cohort Study on the Role of The Triad of Procalcitonin, C-Reactive Protein, and White Blood Cell Count in The Prediction of Anastomotic Leak Following Colorectal Resections

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05159024
Enrollment
205
Registered
2021-12-15
Start date
2018-03-01
Completion date
2020-04-30
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak

Brief summary

The interest in identifying a biological marker for the early detection of AL is growing. Such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. C-reactive protein (CRP) has been identified as a valid parameter for detection of postoperative infectious complications after rectal resection. A serum CRP level greater than 12.4 mg/dL on postoperative day (POD) 4 is considered predictive of septic complications. According to a recent analysis, the changes in the trajectory of CRP levels might be more beneficial than a snipped point. Moreover, the trajectory has a negative predictability of up to 99.3%. Another interesting biomarker is procalcitonin (PCT), the prohormone of calcitonin, produced by parafollicular C cells in the thyroid. Normally, it has a very low plasma concentration in healthy individuals (0.01-0.05 ng/mL), and it increases during severe generalized bacterial, parasitic, or fungal infections, but not in noninfectious inflammatory reactions. Procalcitonin has been described as an early, sensitive, and specific marker of sepsis. Moreover, the plasma concentration of PCT has been used as an early predictor of infection in acute pancreatitis, secondary peritonitis, and infectious complications after thoracic, esophageal, and cardiac surgeries. In addition, elevated white blood cell (WBC) count is associated with AL after gastrointestinal surgeries. Therefore, this study was conducted to evaluate the utility of CRP, PCT, and WBC count trajectories, as separate and combined biomarkers for prediction of AL after colorectal surgery.

Interventions

DIAGNOSTIC_TESTCRP, PCT, and WBCs trajectories

the levels of CRP, PCT, and WBCs were assessed before surgery and after the onset of leak

Sponsors

Mansoura University
CollaboratorOTHER
Suez Canal University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* adult patients of either sex who underwent colorectal surgery entailing an anastomosis

Exclusion criteria

* Patients younger than 18 years * Patients with active infection at the time of surgery * Patients who had received chemotherapy or radiotherapy * Patients on long-term corticosteroid therapy.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leakfive days after surgerySensitivity, specificity and accuracy of combined CRP-PCT- WBCs trajectory

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026