Risk Factors for Postoperative Fever and Sepsis Following Retrograde Intrarenal Surgery
NCT ID: NCT07295925
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
250 participants
OBSERVATIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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Despite its advantages, RIRS is associated with complication rates reported between 9% and 25%. Postoperative fever and urinary tract infection are the most frequently observed complications and may progress to sepsis, which represents a potentially life-threatening condition in patients with urinary stone disease. These infectious events remain a concern even when appropriate antibiotic prophylaxis and aseptic surgical principles are applied. Identifying risk factors that may predict postoperative infection and sepsis is therefore essential for improving perioperative decision-making and patient safety.
Previous studies have suggested potential associations between operative characteristics, preoperative bacteriuria, patient-related comorbidities, and postoperative infectious outcomes; however, most available evidence originates from retrospective analyses with limited variables. There remains a need for prospective, systematically collected data evaluating a broad set of perioperative clinical and laboratory parameters to better define predictive factors.
This prospective patient registry study aims to evaluate comprehensive perioperative variables to identify predictors of postoperative urinary tract infection and sepsis following RIRS. Parameters to be assessed include operative time, stone burden, intraoperative irrigation characteristics, perioperative cultures, and a detailed panel of inflammatory biomarkers such as C-reactive protein, procalcitonin, albumin, fibrinogen, and D-dimer. The study will also record the onset, duration, and severity of postoperative fever, together with other clinical findings relevant to infectious complications. Through this structured approach, the study seeks to determine independent risk factors that may assist clinicians in predicting, preventing, and managing postoperative infection and sepsis in patients undergoing RIRS.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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RIRS Patient Group
Patients undergoing retrograde intrarenal surgery (RIRS) for urinary stone disease who are prospectively followed to identify clinical, laboratory and operative predictors of postoperative fever and sepsis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Pregnancy.
* Contraindications to RIRS or inability to complete required perioperative evaluations.
18 Years
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Emre Can Akınsal
Emre Can Akınsal Assoc. Prof.
Principal Investigators
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Emre C. Akınsal, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Erciyes University Faculty of Medicine, Department of Urology
Emre C. Akınsal, Assoc. Prof.
Role: STUDY_CHAIR
Erciyes University Faculty of Medicine, Department of Urology
Locations
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Erciyes University Faculty of Medicine, Department of Urology
Kayseri, Melikgazi, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Mehmet F. Kesici, M.D.
Role: primary
Emre C. Akınsal, Assoc. Prof.
Role: backup
Other Identifiers
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SEPSIS_AFTER_RIRS_26
Identifier Type: -
Identifier Source: org_study_id