Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Management of Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Stone-free rate on non-contrast computed tomography
研究概览
简要总结
This randomized controlled clinical trial evaluated whether furosemide-assisted forced diuresis during flexible ureteroscopy reduced the residual fragment rate and improved stone clearance in patients with renal stones measuring up to 30 millimeters. Adult patients undergoing flexible ureteroscopy were randomized into two parallel groups: an experimental group that received intravenous furosemide during the procedure and a control group that received standard perioperative and postoperative care without furosemide. Residual stone fragments were assessed using low-dose non-contrast computed tomography on postoperative day 1 and at 6 weeks after the procedure. The primary outcome was the proportion of patients with residual stone fragments greater than 2 millimeters on postoperative day 1. Secondary outcomes included the proportion of patients with residual stone fragments greater than 2 millimeters at 6 weeks, operative time, postoperative complications, and the need for auxiliary treatment for clinically significant residual stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult patients aged 18 years or older.
- •Patients who underwent flexible ureteroscopy for renal stones measuring 30 millimeters or less.
排除标准
- •Patients with active urinary tract infection.
- •Patients with a history of previous open renal surgery or renal trauma.
- •Patients with contraindications to anesthesia, such as severe cardiac disease, uncontrolled diabetes mellitus, or severe coagulation disorder.
- •Patients with severe renal impairment, defined as an estimated glomerular filtration rate less than 30 milliliters per minute per 1.73 square meters.
- •Known Ureteric stricture and pelvi-ureteric junction obstruction
- •Patients with a single kidney.
- •Patients with contraindications to furosemide administration.
- •Patients with congenital renal anomalies.
研究组 & 干预措施
Standard Care During Flexible Ureteroscopy Without Furosemide
Participants underwent flexible ureteroscopy and received standard perioperative and postoperative care without receiving intravenous furosemide or any other diuretic medication.
干预措施: Standard Care After Flexible Ureteroscopy Without Furosemide (Other)
Furosemide-Assisted Forced Diuresis During Flexible Ureteroscopy
During flexible ureteroscopy, participants received intravenous furosemide 40 milligrams total, divided into 20 milligrams administered 5 minutes after induction of anesthesia and 20 milligrams administered 30 minutes after the start of the procedure.
干预措施: Furosemide (Drug)
结局指标
主要结局
Stone-free rate on non-contrast computed tomography
时间窗: After one day and six weeks after flexible ureteroscopy
Stone-free status was assessed using non-contrast computed tomography performed four weeks after the procedure. Residual fragments were classified into four grades: Grade A (no stones), Grade B (0 to 2 millimeters), Grade C (2.1 to 4 millimeters), and Grade D (greater than 4 millimeters, clinically significant residual stones).
Stone-free rate on non-contrast computed tomography
时间窗: After one day and up to six weeks after flexible ureteroscopy
Stone-free status was assessed using non-contrast computed tomography performed four weeks after the procedure. Residual fragments were classified into four grades: Grade A (no stones), Grade B (0 to 2 millimeters), Grade C (2.1 to 4 millimeters), and Grade D (greater than 4 millimeters, clinically significant residual stones).
Proportion of patients with residual stone fragments greater than 2 mm on postoperative day 1
时间窗: Postoperative day 1 after flexible ureteroscopy
Residual stone fragments were assessed using low-dose non-contrast computed tomography (CT) performed on postoperative day 1. The outcome was reported as the proportion of patients with one or more residual renal stone fragments measuring greater than 2 mm.
Proportion of patients with residual stone fragments greater than 2 mm
时间窗: Postoperative day 1 after flexible ureteroscopy
Residual stone fragments were assessed using low-dose non-contrast computed tomography (CT) performed on postoperative day 1. The outcome was reported as the proportion of patients with one or more residual renal stone fragments measuring greater than 2 mm.
Stone-free rate on non-contrast computed tomography
时间窗: Four weeks after flexible ureteroscopy
Stone-free status was assessed using non-contrast computed tomography performed four weeks after the procedure. Residual fragments were classified into four grades: Grade A (no stones), Grade B (0 to 2 millimeters), Grade C (2.1 to 4 millimeters), and Grade D (greater than 4 millimeters, clinically significant residual stones).
次要结局
- Postoperative hematuria(From end of procedure through 6 weeks post-procedure)
- Need for auxiliary treatment for clinically significant residual stones(Up to 6 weeks after flexible ureteroscopy)
- Proportion of patients with residual stone fragments greater than 2 mm at 6 weeks(6 weeks after flexible ureteroscopy)
- Operative time(During procedure)
- Length of hospital stay(From end of procedure to hospital discharge (up to 7 days))
- Postoperative hematuria(From end of procedure through 4 weeks post-procedure)
- Postoperative urinary tract infection(Within 7 days post-procedure)
- Postoperative pain score(Recovery room (PACU), postoperative day 1, and at discharge (up to 7 days))
- Need for auxiliary treatment for clinically significant residual stones(Up to four weeks after flexible ureteroscopy)
研究者
Ahmed Nasser Karamany Mokhat
Resident of Urology
Ain Shams University