UrolithiasisSARISNCT07295925
Risk Factors for Postoperative Fever and Sepsis Following Retrograde Intrarenal Surgery
An observational study of Urolithiasis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to evaluate preoperative, intraoperative, and postoperative characteristics of patients undergoing retrograde intrarenal surgery (RIRS) for urinary stone disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2026to Dec 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erciyes University Faculty of Medicine, Department of Urology
Kayseri, Melikgazi, 38140
Mehmet F. Kesici, M.D., +90554 661 30 33, mehmetfurkankesici@erciyes.edu.tr
Emre C. Akınsal, Assoc. Prof., +90352 207 66 66 ext. 22107, ecakinsal@erciyes.edu.tr
About this study
Official title: Prospective Evaluation of Clinical, Laboratory and Operative Predictors of Postoperative Fever and Sepsis After Retrograde Intrarenal Surgery (RIRS)
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.
Read the 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.
- Conditions
- Urolithiasis
- Keywords
- RIRS, Sepsis, Urolithiasis, Endourology, Retrograde Intrarenal Surgery, Postoperative Fever, Postoperative Sepsis, Ureteroscopy
- Medical subject headings
- Urolithiasis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 72 hours after surgery
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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.
Measured: Within 72 hours
Number of Participants with Positive Postoperative Blood Culture
Detection of pathogenic microorganisms from blood samples obtained in the postoperative period.
Measured: 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
Measured: 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
Measured: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Can Akınsal, TC Erciyes University
- Investigators
- Emre C. Akınsal, Assoc. Prof., Principal investigator, Erciyes University Faculty of Medicine, Department of UrologyEmre C. Akınsal, Assoc. Prof., Study chair, Erciyes University Faculty of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295925
- Sponsor's protocol ID
- SEPSIS_AFTER_RIRS_26
- Acronym
- SARIS
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Clinical, Laboratory and Operative Predictors of Postoperative Fever and Sepsis After Retrograde Intrarenal Surgery (RIRS)
- ClinicalTrials.gov ID
- NCT07295925
- Acronym / sponsor ID
- SARIS / SEPSIS_AFTER_RIRS_26
- Conditions
- Urolithiasis
- Keywords
- RIRS, Sepsis, Urolithiasis, Endourology, Retrograde Intrarenal Surgery, Postoperative Fever, Postoperative Sepsis, Ureteroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Postoperative Sepsis
Time frame: Within 72 hours after surgery
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).
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emre C. Akınsal, Assoc. Prof. principal investigator
Erciyes University Faculty of Medicine, Department of Urology
Emre C. Akınsal, Assoc. Prof. study chair
Erciyes University Faculty of Medicine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet F. Kesici, M.D. (+90554 661 30 33, mehmetfurkankesici@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Sepsis (time frame: Within 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.