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Completed

NCT Number: NCT05159024

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRP, PCT, and WBCs trajectories

Diagnostic Test

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

Primary outcomes

  1. Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak

    Time frame: five days after surgery

    Sensitivity, specificity and accuracy of combined CRP-PCT- WBCs trajectory

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 15, 2021
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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