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临床试验/NCT01222325
NCT01222325已完成不适用

Comparison Between Two Shock Wave Regimens Using Frequencies of 60 and 90 Impulses Per Minute for Urinary Stones

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
2
主要终点
abdominal ultrasound and abdominal x rays (KUB)

研究概览

简要总结

In order to check if a reduction in the frequency and total number of shocks delivered during extracorporeal shockwave lithotripsy (SWL) results in a great number of stone-free patients,the investigators compared two different ways of treating urinary stones using SWL.

详细描述

Purpose: Two different regimens of SWL delivery for treating urinary stones were compared.

Methods: After informed consent, patients with previously untreated renal and ureteric stones were admitted for an initial treatment by SWL between June 2008 and May 2009. Patients were randomly divided into two groups; one group received 3000 impulses at a rate of 60 impulses per minute, and the other received 4000 impulses at a rate of 90 impulses per minute. Patients submitted to re-treatment of the same stone were excluded. All treatments were done using the Dornier Compact Delta lithotripter. Stones were located by x-ray or ultrasound. Prior to treatment, patients were submitted to laboratory tests and a cardiologic evaluation when indicated. Urinary infections were treated prior to the SWL session. All procedures were performed under general anesthesia. Briefly, Tramadol 1-2 mg/kg associated to Propofol 2.5-3.0 mg/kg and scopolamine were employed in the majority of the procedures. Patients received 50-100 mg of diluted Tramadol and 20 mg of scopolamine just before the beginning of the SWL session and Propofol was maintained on continuous bomb infusion during the treatment and interrupted three minutes before the end of the session. All patients were maintained under spontaneous breathing, and a facial or a laryngeal oxygen mask was used according to the anesthesiologist's judgment. The potency of the lithotripter was increased progressively by 300 shocks until reaching the final stage, which occurred at a mean of 1500 shocks. The maximum potency employed was level 4 (equivalent to 14 kV) for renal stones and level 6 (16 kV) for ureteric stones.

All patients were treated on an outpatient basis and were discharged from the hospital six hours after treatment. All patients received non-steroidal anti-inflammatory drugs (NSAIDs) and Dipyrone in combination with to Hyoscine for three days postoperatively unless contraindicated and were instructed to come to the emergency department in case of severe pain, fever or hematuria.

The final results for each patient were assessed with a kidney and urinary bladder scan (KUB) plus an abdominal ultrasound three months after the procedure. Success was defined as stone-free status or the detection of residual fragments ≤ 3 mm on final evaluation. Partial fragmentation was considered to have occurred if a significant reduction in the stone burden was observed but residual fragments bigger than 3 mm remained.

We evaluated overall stone-free rates, the incidence of unchanged stones and the occurrence of partial fragmentation as well as the occurrence of significant complications in both groups.

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
6 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with renal or ureteral stones from 5 to 20 mm

排除标准

  • pregnancy
  • coagulation disturbs and antiplatelet treatment
  • urinary tract infection
  • aortic aneurism bigger than 2 cm
  • clinical contraindication to general anesthesia
  • refusal in participating of the protocol

结局指标

主要结局

abdominal ultrasound and abdominal x rays (KUB)

时间窗: 3 months

patients submitted to SWL in two different regimens were submited to renal ultrasound and abdominal x rays (KUB) three months after procedure to check the occourrence of stone-free status, residual fragments or unmodified stone.

次要结局

  • adverse effects of the two different regimens(3 months)

研究者

申办方类型
Other

研究点 (2)

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