The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The change in urine NGAL/Cr value
研究概览
简要总结
The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.
详细描述
This is a 3-arm parallel group prospective randomized active-treatment clinical study. A total of 75 patients with renal calculi 10-30 mm in maximal diameter measured in abdominal CT scan will be recruited in this research protocol. Patient enrollment will be performed from patients referred to Urolithiasis Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki. In all potentially eligible patients full medical history, as well as demographic characteristics and drug treatment will be recorded, followed by a detailed physical examination and standard laboratory tests.
Eligible patients will be randomized to receive one of the following endourological techniques of nephrolithotripsy: standard PCNL, mini- PCNL or RIRS. All eligible patients will be randomised to one of the 3 groups, consisting of 25 patients, with an equal allocation ratio (1:1). The randomization sequence will be computer generated by the study coordinating team.
The primary and secondary measurements of the study will be carried in prespecified time-points that are listed below:
Point 0(P0): Screening visit:
Potentially eligible patients will be asked to provide written informed consent. We will record full medical history, concomitant medication, clinical examination, demographic characteristics, body weight, height, body mass index (BMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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 aged > 18 years old
- •Patients with renal stone or stones of 10-30 mm in maximal diameter measured in computed tomography scan.
- •Decision of the patient to receive surgical treatment
- •Ability to understand and provide a written informed consent to participate in the study.
排除标准
- •Solitary kidney (functional or organic)
- •Ureteral stone in the same system causing obstruction
- •Malignant tumor in the treated kidney
- •Stone in diverticulum
- •Diabetes or coronary heart disease.
- •History of surgery in the treated kidney
- •Recent intake of drugs that affect renal function or intravenous contrast agent
- •Concomitant urinary infection
- •Congenital anomalies of the urinary tract
- •Patients of whom incomplete clinical data or incomplete samples are available
结局指标
主要结局
The change in urine NGAL/Cr value
时间窗: 2 hours preoperative and 2 hours postoperatively
Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
次要结局
- The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with mini - PCNL technique(2, 6, 24, 48 hours postoperatively)
- Postoperative pain, in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(Immediately after the operation and in 2, 6, 24, 48 hours postoperatively.)
- The change in serum creatinine and eGFR values postoperatively in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(1 month and 3 months postoperatively)
- Fluoroscopy time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation)
- Hospital stay duration in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(From the day of operation until the day of discharge, up to 7 days)
- The change in urine NGAL/Cr value(2 hours preoperative and 6, 24, 48 hours postoperatively)
- The change in urine KIM-1/Cr value(2 hours preoperative and 2, 6, 24, 48 hours postoperatively)
- The presence of Acute Kidney Injury(AKI) in patients undergoing PCNL, mini-PCNL or RIRS(from the time of operation until 48 hours postoperatively)
- Overall complications rates in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(from the time of operation until the 3 month follow up visit)
- The change in urine IL-18/Cr value(2 hours preoperative and 2, 6, 24, 48 hours postoperatively)
- The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with mini -PCNL and those undergone nephrolithotripsy with RIRS technique(2, 6, 24, 48 hours postoperatively)
- The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with RIRS technique(2, 6, 24, 48 hours postoperatively)
- Percent of patients achieving treatment success and stone-free state in after undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(4 weeks postoperatively)
- Operation time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.(- from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation)
研究者
Dimitrios Hatzichristou
President
Institute for the Study of Urological Diseases, Greece