跳至主要内容
临床试验/NCT07295925
NCT07295925尚未招募不适用

Prospective Evaluation of Clinical, Laboratory and Operative Predictors of Postoperative Fever and Sepsis After Retrograde Intrarenal Surgery (RIRS)

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Number of Participants With Postoperative Sepsis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Number of Participants With Postoperative Sepsis

时间窗: 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).

次要结局

  • 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)
  • Length of Hospital Stay (days)(From the date of surgery until hospital discharge, assessed up to 30 days postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre Can Akınsal

Emre Can Akınsal Assoc. Prof.

TC Erciyes University

研究点 (1)

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