Risk Factors for Postoperative Fever and Sepsis Following Retrograde Intrarenal Surgery
ConditionUrolithiasis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTC Erciyes University
About this trial
This prospective clinical study aims to evaluate preoperative, intraoperative, and postoperative characteristics of patients undergoing retrograde intrarenal surgery (RIRS) for urinary stone disease. A total of approximately 250 patients will be assessed to identify clinical, laboratory, and operative factors associated with postoperative fever and sepsis. By systematically collecting and analyzing perioperative data, the study seeks to determine independent predictors that may support improved risk stratification and patient safety in endourological practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Patients scheduled to undergo retrograde intrarenal surgery (RIRS) for the treatment of renal or ureteral stones.
Completion of routine preoperative and postoperative clinical assessments required for RIRS.
Ability to provide informed consent.
Disqualifiers
Terminal-stage malignancy.
Bleeding diathesis or known immunodeficiency.
Active infectious condition at the time of surgery.
Patients deemed unsuitable for anesthesia or surgery by the Department of Anesthesiology.
Trial population
The study population consists of adult patients undergoing retrograde intrarenal surgery (RIRS) for the treatment of renal or ureteral stones at Erciyes University Hospital. All participants are evaluated using standard preoperative laboratory tests, imaging studies, and perioperative clinical assessments. Patients included in this registry represent a typical endourological population treated with RIRS in routine clinical practice. Individuals with active infections at the time of surgery, contraindications to surgery, or conditions preventing informed consent are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: RIRS Patient Group
Trial outcomes
Primary outcomes
1
Number of Participants With Postoperative Sepsis
Postoperative sepsis will be defined according to Sepsis-3 criteria, based on suspected or confirmed infection and an increase of ≥ 2 points in the Sequential Organ Failure Assessment (SOFA) score within 72 hours after retrograde intrarenal surgery (RIRS).
Time frame
Within 72 hours after surgerySecondary outcomes
1
Number of Participants With Postoperative Fever
Postoperative fever will be defined as a body temperature ≥38ºC recorded at least twice within 72 hours after retrograde intrarenal surgery (RIRS).
Time frame
Within 72 hours after surgery2
Number of Participants With Systemic Inflammatory Response Syndrome (SIRS)
SIRS will be defined according to standard clinical criteria, including abnormalities in body temperature, heart rate, respiratory rate and leukocyte count after retrograde intrarenal surgery (RIRS).
Time frame
First 24 hours after surgery3
Number of Participants With Positive Postoperative Urine Culture
Growth of ≥10⁵ CFU/mL of a single organism in a postoperative urine culture.
Time frame
Within 72 hours4
Number of Participants with Positive Postoperative Blood Culture
Detection of pathogenic microorganisms from blood samples obtained in the postoperative period.
Time frame
Within 72 hoursSponsors and contacts
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Source ClinicalTrials.gov
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