Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The primary outcome was to assess the effectiveness of the laser.
研究概览
简要总结
The aim of this study is to compare the efficacy and safety of Thulium Fiber Laser (TFL) litothripsy according to stone density and the factors affecting success in patients undergoing retrograde intrarenal surgery (RIRS) for renal calculi >1000 mm3. Between November 2023 and December 2024, 81 patients with a stone volume >1000 mm3 who underwent RIRS with TFL in our clinic were prospectively and sequentially evaluated. Stone density of the patients was measured, and expressed in Hounsfield Units (HU). Patients with stone densities <1000 HU and ≥1000 HU were categorized as Groups 1, and 2, respectively. Demographic data, data of intraoperative laser use, stone-free rates (SFRs), the need for a second session of RIRS and complications were recorded. Duration of TFL litothripsy, total energy used, laser ablation speed (mm3/sec), laser ablation efficiency (mm3/J) and laser energy consumption (J/mm3) were calculated. Correlation tests, univariate and multivariate logistic regression tests were used for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age
- •Presence of kidney stones larger than 1000 mm³
- •Patients with single or multiple kidney stones
- •Patients eligible for retrograde intrarenal surgery (RIRS)
排除标准
- •Patients younger than 18 years
- •Pregnant or breastfeeding women
- •Patients with uncorrected coagulopathy
- •Patients with active urinary tract infection
- •Patients with severe anatomic abnormalities preventing RIRS
- •Patients unwilling or unable to provide informed consent
研究组 & 干预措施
Safety and Efficacy of Thulium Fiber Laser for Large Renal Stones
Demographic data (age, gender, body mass index (BMI)), stone characteristics (size, location, Hounsfield Unit (HU) value) and durations of the procedures were recorded. Patients over 18 years of age, with kidney stones larger than 1000 mm³, single or multiple stones and those eligible for RIRS were included in the study. Patients under 18 years of age, those with bleeding diathesis or inability to discontinue anticoagulant/antiaggregant therapy, cases with a history of previous RIRS, individuals who did not attend follow-up visits, patients in whom postoperative residual stone assessment could not be made, or had concomitant bladder or ureteral stones were excluded. SFRs, the need for a second session of RIRS and complications were noted. General anesthesia was used. Rigid ureteroscope was inserted through urethral meatus. 11/13 F ureteral sheath was advanced over guidewire under fluoroscopy. Laser settings varied 0.2J/100Hz to 1J/10Hz based on stone fragility.
干预措施: Effectivity of TFL on large renal stone (Device)
结局指标
主要结局
The primary outcome was to assess the effectiveness of the laser.
时间窗: 12 months
Fragmentation success was used to evaluate the laser effectiveness of laser.
次要结局
- The secondary outcome was the evaluation of factors affecting stone-free rates(3 months)
研究者
Muharrem Baturu
assistant professor
University of Gaziantep