Massage Percussion Therapy for Passage of Urolithiasis Fragments After Ureteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Patients who are able to tolerate and complete the percussion therapy.
研究概览
简要总结
Flexible ureteroscopy is characterized as first-line therapy for renal stones < 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Quoted stone free rate after flexible ureteroscopy is approximately 40-60% with a dusting technique. Residual fragments are often under 1mm in size and can layer in the lower pole of the kidney, complicating spontaneous stone passage. Improving the stone free rate after surgery decreases the need for secondary surgeries and decreases risk of future stone events.
Numerous techniques have been proposed to increase stone passage including positional changes and percussion therapy. To date, there is overall limited data a lack of techniques that can be readily available in the outpatient setting, easily added to scheduled appointments, reproducible results and well tolerated by patients.
详细描述
Researchers in China have developed a proprietary oscillation machine to be used in an outpatient setting. The External Physical Vibration Lithecbole (EPVL) is used to provide vibration after stone fragmentation to facilitate movement of fragments into a more favorable orientation for stone passage. After extracorporeal shockwave lithotripsy and ureteroscopy, use of EPVL after surgery has been shown to increase stone free rate.
Chest percussion for cystic fibrosis patients has been adapted for use after ureteroscopy. After undergoing extracorporeal shockwave lithotripsy, patients are placed in a percussion physiotherapy vest, given diuretics and positioned in Trendelenburg. Imaging obtained before and after percussion demonstrates successful stone movement and increases stone free rates in several different protocols compared to patients who do not receive percussive therapy.
Percussion therapy is clearly effective to improve stone free rates after ureteroscopy and is effective regardless of technique, protocol, or percussive device. However, proposed techniques with EPVL and chest physiotherapy vests can be expensive, cumbersome and require specialty equipment. In addition, proposed equipment in prior studies is not readily available in outpatient clinics.
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
- 是
入选标准
- •Any patient after treatment of renal stones with ureteroscopy during which residual stone fragments (less than 2mm by surgeon estimation) is left in the kidney.
- •Must be 18 years or older
- •Must be able to give consent
- •Preoperative abdominal CT
排除标准
- •On pharmacologic anticoagulation. Aspirin up to 81mg will be allowed.
- •Cannot tolerate flank, prone or Trendelenburg position.
- •Cannot tolerate percussion.
- •History of acute rib fractures or osteopenia/osteoporosis.
- •Any patient who is on a fluid intake restriction.
- •Pregnancy
- •Untreated UTI
- •History of struvite stones
- •Requiring a planned secondary stone procedure within 90 days
- •If stent must stay in longer than 10 days
- •Ureteral stones (without renal stones)
研究组 & 干预措施
Control
Patient receives standard postoperative care with no percussion therapy.
PACU percussion
Patient receives percussion therapy in the PACU immediately after surgery.
干预措施: Massage Percussion Therapy device (Device)
Postoperative appointment percussion
Patient receives percussion therapy in the office on the day of follow up.
干预措施: Massage Percussion Therapy device (Device)
Both PACU and Postop appointment percussion.
Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up.
干预措施: Massage Percussion Therapy device (Device)
结局指标
主要结局
Patients who are able to tolerate and complete the percussion therapy.
时间窗: Postop day 0-10.
If patients can tolerate the percussion therapy in the treatment arms. This is evaluated by patients being able to complete the percussion therapy session and completing pain questionnaires.
Stone Free Rate.
时间窗: 6 weeks after surgery.
Patients will have standard postoperative imaging at six weeks, as is standard of care. Presence of stone fragments and fragment size will determine the postoperative stone free rate.
次要结局
- Unplanned return visits.(6 weeks.)
- weight of passed stone fragments(6 weeks.)
研究者
Ryan Hsi
Urologist
Vanderbilt University Medical Center