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

NCT05159024 | Completed

• 1 other identifier: Trajectory2021
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with leak after colorectal anastomosis

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

Diagnostic Test: CRP, PCT, and WBCs trajectories

Interventions

CRP, PCT, and WBCs trajectories DIAGNOSTIC_TEST

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

Patients with leak after colorectal anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

205 patients who had colorectal surgery, all patients had a diagnosis of new or previous colorectal cancer. 56.1% of patients were males and 43.9% were females. Patient age ranged from 25 to 78 years, with a mean of 56.4 years

You may qualify if:

• adult patients of either sex who underwent colorectal surgery entailing an anastomosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead
• Mansoura University: collaborator

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of surgery

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 15, 2021
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: April 30, 2020
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

EG (1)