An observational study in Urolithiasis, sponsored by TC Erciyes University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by TC Erciyes University · Observational
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.
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.
253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 65 observational studies indexed under Urolithiasis.
Browse Urolithiasis studies →TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 surgery
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 surgery
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 surgery
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 hours
Number of Participants with Positive Postoperative Blood Culture
Detection of pathogenic microorganisms from blood samples obtained in the postoperative period.
Time frame: Within 72 hours
Number of Participants With Positive Stone Culture
Presence of bacterial growth in stone culture obtained during retrograde intrarenal surgery (RIRS), defined as any clinically significant pathogen isolated from stone fragments
Time frame: Up to 72 hours after surgery
Length of Hospital Stay (days)
Length of hospital stay will be defined as the number of days from the date of surgery to the date of hospital discharge
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively.
Plan to share: No
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