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

Sponsor
Suez Canal University (Other)
Overall Status
Completed
CT.gov ID
NCT05159024
Collaborator
Mansoura University (Other)
205
1
26
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CRP, PCT, and WBCs trajectories

Study Design

Study Type:
Observational
Actual Enrollment :
205 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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
the levels of CRP, PCT, and WBCs were assessed before surgery and after the onset of leak

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura university hospital Mansourah Dakahlia Egypt 35516

Sponsors and Collaborators

  • Suez Canal University
  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Waleed Ghareeb, Lecturer of surgery, Suez Canal University
ClinicalTrials.gov Identifier:
NCT05159024
Other Study ID Numbers:
  • Trajectory2021
First Posted:
Dec 15, 2021
Last Update Posted:
Dec 15, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 15, 2021