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

Completed

• Conditions: Anastomotic Leak
• Interventions: Diagnostic Test: CRP, PCT, and WBCs trajectories

• Registration Number: NCT05159024
• Lead Sponsor: Suez Canal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-30
• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with leak after colorectal anastomosis	CRP, PCT, and WBCs trajectories	Patients who developed anastomotic leak, clinical or radiologic, after colorectal resection and anastomosis

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak	five days after surgery	Sensitivity, specificity and accuracy of combined CRP-PCT- WBCs trajectory

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt