Optimal Duration Between Drainage for Obstructing Renal or Ureteral Stones Associated With Infection and Ureteroscopic Lithotripsy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Percentage of postoperative infectious complications in treatment groups
研究概览
简要总结
This study will be conducted to compare early (seven days) versus delayed (14-21 days) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.
详细描述
All the study participants will be monitored during the early post-operative period for post-operative pain and complications. The rate and grade of reported complications will be determined according to modified Dindo-Clavian grading system. After ensuring safe status for discharge, all patients will be reassessed at the outpatient department after 4 weeks by NCCT to assess stone free status.
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
- 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
- •Obstructing ureteral or renal stone <20 mm.
- •Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS).
排除标准
- •History of endoscopic instrumentation to the urinary tract in the last 4 weeks prior to presentation.
- •Bilateral obstructed kidneys necessitating bilateral drainage.
- •Associated emphysematous pyelonephritis or perinephric abscess.
研究组 & 干预措施
Early
Patients will be managed by ureteroscopic lithotripsy 7 days after drainage.
干预措施: Early ureteroscopy (Procedure)
Delayed
Patients will be managed by ureteroscopic lithotripsy 14-21 days after drainage.
干预措施: Delayed Ureteroscopy (Procedure)
结局指标
主要结局
Percentage of postoperative infectious complications in treatment groups
时间窗: 30 days
Difference in post-URS infectious complications between the study groups. infectious complications are defined as presence of urinary tract infection with one of the following findings: - Body temperature more than 38.3C or below 36C. - Tachycardia (\>90/minute). - Respiratory rate more than 20/minute. - Disturbed mental status. - Systolic blood pressure \< 90 mmHg \& mean arterial pressure \< 70 mmHg or systolic blood pressure decrease \< 40 mmHg. - WBC \>12,000 or \<4,000.
次要结局
未报告次要终点
研究者
Ahmed R EL-Nahas
Professor of Urology
Mansoura University