Safety and Efficacy of Percutaneous Nephrolithotripsy Versus Retrograde Intrarenal Surgery for Obese Patients With Pelvic 1.5:3 cm Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- stone free rate
研究概览
简要总结
This prospective randomized comparative study was done at Helwan University Hospital. It was conducted on 120 patients with unilateral pelvic renal stones from 1.5 to 3 cm in largest diameter who was admitted through duration to compare the two procedures differences in terms of complications, analgesic use, hospital stay, operational time, and stone-free rates.
详细描述
In this study, 182 patients were assessed for eligibility; 62 patients were excluded, 48 of which were not meeting our inclusion criteria and 14 patients declined to participate in the study as detailed in the CONSORT flowchart
After meeting our inclusion and exclusion criteria, 120 patients were thoroughly informed about the study and after feeling well about participating in it a written informed consent was taken from them. Patients were randomly divided into two equal groups using a closed envelope technique into:
- Group A: 60 patients were undergone percutaneous nephrolithotomy, three patients were lost in follow up and one case was excluded due to stricture urethra. So, the investigators analysed 56 patients.
- Group B: 60 patients were undergone retrograde intrarenal surgery, one patient was lost in follow up and one case was aborted due to narrow ureter & DJ was applied. So, the investigators analysed 58 patients
All participants were submitted to preoperative assessment:
History-taking, clinical examination, laboratory examination (urine analysis, urine culture and sensitivity, blood urea, creatinine levels, complete blood counts, and coagulation profile), Imaging modalities: ultrasonography, plain radiograph of kidney-ureter-bladder (KUB) and non-contrast computed tomography (CT).
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
- •Obese adult patients with body mass index ≥30
- •aged ≥ 18 years
- •unilateral pelvic renal stone from 1.5 to 3 cm in largest diameter.
- •Exclusion criteria:
- •A single kidney
- •renal impairment (serum creatinine > 1.4 mg/dl)
- •patients with uncontrolled co-morbidities (hypertension, diabetes mellitus, cardiac disease, chest disease)
- •active Urinary tract infection
- •ureteric or bladder stones
- •anatomic renal abnormalities (congenital renal malformations such as horseshoe kidney, polycystic kidney disease, etc.)
- •people with severe skeletal deformity
- •pregnant women
- •history of ureteric strictures
- •uncorrectable bleeding disorder.
排除标准
- 未提供
结局指标
主要结局
stone free rate
时间窗: one month
Stone-free or stone residual \< 3 mm after just one session of the therapy were considered successful outcomes.Data were gathered, edited, coded, and entered into IBM SPSS version 23 of the Statistical Package for Social Science.
次要结局
- complications(two weeks)
- operation time(during procedure ( till five hours))
- hospital stay(from the day of procedure till the day of discharge from hospital (two weeks))
- analgesic use(from the day of procedure till the day of discharge from hospital (two weeks))
研究者
bassem metwally
Principal Investigator
Helwan University