Risk Factors for Postoperative Fever and Sepsis Following Retrograde Intrarenal Surgery

NCT07295925 | Not Yet Recruiting

• 1 other identifier: SEPSIS_AFTER_RIRS_26
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urolithiasis

Keywords

RIRS; Sepsis; Urolithiasis; Endourology; Retrograde Intrarenal Surgery; Postoperative Fever; Postoperative Sepsis; Ureteroscopy

Outcome Measures

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).

  Within 72 hours after surgery

Secondary Outcomes (6)

• Number of Participants With Postoperative Fever

  Within 72 hours after surgery

• Number of Participants With Systemic Inflammatory Response Syndrome (SIRS)

  First 24 hours after surgery

• Number of Participants With Positive Postoperative Urine Culture

  Within 72 hours

• Number of Participants with Positive Postoperative Blood Culture

  Within 72 hours

• Number of Participants With Positive Stone Culture

  Up to 72 hours after surgery

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine, Department of Urology

Kayseri, Melikgazi, 38140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urolithiasis; Sepsis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emre C. Akınsal, Assoc. Prof.

  Erciyes University Faculty of Medicine, Department of Urology

  PRINCIPAL INVESTIGATOR

• Emre C. Akınsal, Assoc. Prof.

  Erciyes University Faculty of Medicine, Department of Urology

  STUDY CHAIR

Central Study Contacts

Mehmet F. Kesici, M.D.

CONTACT

+90554 661 30 33; mehmetfurkankesici@erciyes.edu.tr

Emre C. Akınsal, Assoc. Prof.

CONTACT

+90 352 207 66 66; ecakinsal@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emre Can Akınsal Assoc. Prof.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)