Crp( c reactive protein) as a predictive marker in anastomotic leak
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of postoperative C-reactive protein levels in predicting anastomotic leak, measured by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (ROC) curve.
Study Overview
Brief Summary
Crp as a predictive marker in anastomotic leak Anastomotic leak remains one of the most serious complications following gastrointestinal surgery, contributing significantly to postoperative morbidity, mortality, prolonged hospital stay, and increased healthcare costs. Early diagnosis of anastomotic leak is challenging due to its often subtle and nonspecific clinical presentation in the immediate postoperative period. Therefore, there is a need for reliable, easily available biomarkers that can facilitate early detection or safe exclusion of this complication.C-reactive protein (CRP) is an acute-phase reactant synthesized by the liver in response to inflammatory stimuli and is routinely measured in the postoperative setting. This thesis evaluates the role of postoperative CRP as a predictive marker for anastomotic leak. Serial CRP levels were analyzed, with particular emphasis on postoperative day (POD) 3 to 5, a period during which physiological postoperative inflammation is expected to decline in uncomplicated cases.
The study demonstrates that persistently elevated or rising CRP levels beyond POD 3 are significantly associated with the development of anastomotic leak. CRP showed high diagnostic accuracy, particularly a high negative predictive value, indicating its usefulness in excluding anastomotic leak when levels fall below established cut-off values. Receiver operating characteristic (ROC) analysis identified optimal CRP thresholds for predicting anastomotic leak, supporting its role as an early warning marker.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient aged 18 years and above Patients undergoing elective gastrointestinal surgery involving vowel anastomosis ( eg colorectal,small bowed or gastric) Patients with primary anastomosis without diverting stoma.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Diagnostic accuracy of postoperative C-reactive protein levels in predicting anastomotic leak, measured by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (ROC) curve.
Time Frame: Primary time point-POD 3 CRP | Secondary time points- POD 4 and POD 5 | Optional: include pod 1-2 for trend analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Arun Kumar Gupta
Sri guru Ramdas insitute of medical sciences and research,Vallabh,Amritsar
