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Clinical Trials/CTRI/2026/04/109283
CTRI/2026/04/109283Not yet recruitingNot Applicable

Crp( c reactive protein) as a predictive marker in anastomotic leak

Sri guru ram Das university of medical sciences1 site in 1 country100 target enrollmentStarted: May 5, 2026Last updated:
Conditions

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

Sponsor
Sri guru ram Das university of medical sciences
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Arun Kumar Gupta

Sri guru Ramdas insitute of medical sciences and research,Vallabh,Amritsar

Study Sites (1)

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