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

NCT ID: NCT05159024

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-04-30

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.

Conditions

Anastomotic Leak

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with leak after colorectal anastomosis

Patients who developed anastomotic leak, clinical or radiologic, after colorectal resection and anastomosis

CRP, PCT, and WBCs trajectories

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

CRP, PCT, and WBCs trajectories

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: collaborator

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Waleed Ghareeb

Lecturer of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

Trajectory2021

Identifier Type: -

Identifier Source: org_study_id