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

Anastomotic Leak Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159024
• Other study ID #: Trajectory2021
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2021
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 30, 2020
• Est. primary completion date: March 1, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Diagnostic Test:
• CRP, PCT, and WBCs trajectories
the levels of CRP, PCT, and WBCs were assessed before surgery and after the onset of leak

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (2)

Lead Sponsor	Collaborator
Suez Canal University	Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak	Sensitivity, specificity and accuracy of combined CRP-PCT- WBCs trajectory	five days after surgery