Risk Factors for Postoperative Fever and Sepsis Following Retrograde Intrarenal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urolithiasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation of Clinical, Laboratory and Operative Predictors of Postoperative Fever and Sepsis After Retrograde Intrarenal Surgery (RIRS)
Overview
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.
Detailed description
Urinary stone disease is a common global health problem with an increasing incidence and significant clinical and economic burden. Retrograde intrarenal surgery (RIRS) has become a widely accepted, minimally invasive, and effective treatment option for renal and proximal ureteral stones. Advances in flexible ureteroscope design, laser technologies, and endourological instrumentation have further improved the safety, efficiency, and applicability of RIRS. As a result, there has been a marked increase in the preference for RIRS among urologists in recent years.
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.
Primary outcome measures
- Number of Participants With Postoperative Sepsis [Time frame: Within 72 hours after surgery]
Secondary outcome measures (6)
- Number of Participants With Postoperative Fever [Time frame: Within 72 hours after surgery]
- Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) [Time frame: First 24 hours after surgery]
- Number of Participants With Positive Postoperative Urine Culture [Time frame: Within 72 hours]
- Number of Participants with Positive Postoperative Blood Culture [Time frame: Within 72 hours]
- Number of Participants With Positive Stone Culture [Time frame: Up to 72 hours after surgery]
- Length of Hospital Stay (days) [Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Pregnancy.
- Contraindications to RIRS or inability to complete required perioperative evaluations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Erciyes University Faculty of Medicine, Department of Urology — Kayseri
Identifiers
NCT: NCT07295925 · SEPSIS_AFTER_RIRS_26