Clinical trial NCT05159024: Role of Procalcitonin, C-Reactive Protein, and WBC Count in Prediction of Colorectal Anastomotic Leak
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak
Lead sponsor: Suez Canal University
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2021-12-15
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Diagnostic accuracy of combined CRP-PCT- WBC trajectory in prediction of anastomotic leak
timeFrame: five days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
References: