Clinical Trials Directory

Trials / Completed

CompletedNCT05159024

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
Phase
Study type
Observational
Enrollment
205 (actual)
Sponsor
Suez Canal University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Conditions

Interventions

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

Timeline

Start date
2018-03-01
Primary completion
2020-03-01
Completion
2020-04-30
First posted
2021-12-15
Last updated
2024-07-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05159024. Inclusion in this directory is not an endorsement.