External Physical Vibration Lithecbole Versus Traditional Row of Stone After Extracorporeal Shockwave Lithotripsy(ESWL)
NCT ID: NCT02643134
Last Updated: 2015-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2015-08-31
2016-07-31
Brief Summary
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Detailed Description
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Investigators plan to beginning their study August 2015 and end at July 2016. One hundred and eighty patients with ESWL postoperative residual stone will be enrolled in this study. By simple random sampling technique, all the patients will be assigned to the segment of natural stone row group or physical row of stone group, compared two groups of patients with stone clearance rate and complications, Investigators hope that through this test, improve stone clearance rate after ESWL.
Number:
180cases(90 cases in control group, 90 cases in EPVL group)
Grouping methods:
In this trial, investigators will use equilibrium randomization methods that generate random numerical code table, according to the table, patients are randomly assigned to different groups.
Evaluating indicator Stone-free rate in 4 weeks after ESWL. Incidence rate of complications and adverse reactions after EPVL(fever, hematuria, etc).
Trial method:
Examination before ESWL: blood routine, urine routine, renal function(Cre,BUN), coagulation function; intravenous pyelography(IVP) or CT (radiolucent calculus).
ESWL
Record: duration, frequency, voltage, times.
Method of control group(group1):
ESWL without EPVL; Reexamined by abdominal plain film(KUB) or CT (radiolucent calculus) right after ESWL;
After leaving hospital(without drugs), patients should follow the measures bellowed:
1. the amount of fluid intake is more than 2000ml/d
2. increase physical activity
3. rest in position on uninjured side, patients with lower renal calyx calculus need to invert body.
Method of EPVL group(group2):
Start the treatment of EPVL: the amount of fluid intake is about 1000-2000ml, start the treatment of EPVL when patent's bladder is filling; Reexamined by abdominal plain film(KUB) or CT(radiolucent calculus) right after EPVL;
Record: patients' date, treatment procedure and outcome;
After leaving hospital(without drugs), patients should follow the measures bellowed:
1. the amount of fluid intake is more than 2000ml/d
2. increase physical activity
3. rest in position on uninjured side, patients with lower renal calyx calculus need to invert body;
Follow up timing: return hospital respectively in 1,2 and 4 weeks after EPVL.
Follow up project Laboratory testing: routine urinalysis; Imaging examination: KUB or kidney CT scan (radiolucent calculus) Complications and adverse reactions. Data gathering Fill in follow up table data; Radiological images; IVP or kidney CT scan before ESWL; Reexamined by KUB (radiopaque calculus) or CT (radiolucent calculus) right after EPVL. If stones have been eliminated completely in patients with radiolucent calculus before or at the fourth week of follow-up, investigators must provide kidney CT scan.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).
extracorporeal shockwave lithotripsy
Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).
Group 2
Patients in Group 2 undergo external physical vibration lithecbole for the treatment after extracorporeal shockwave lithotripsy(ESWL).A multi-dimensional physical harmonic vibration inertial guidance technology
External Physical Vibration Lithecbole
Multi-dimensional physical harmonic vibration inertial guidance technology
Interventions
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extracorporeal shockwave lithotripsy
Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).
External Physical Vibration Lithecbole
Multi-dimensional physical harmonic vibration inertial guidance technology
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The diameter of calculus is less than or equal to 15mm;
3. Renal or upper ureteral calculus;
4. There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;
5. Stones are fragmented successfully on single session of ESWL, and the diameter of any of fragments is less than 6mm;
6. Normal renal function,
Exclusion Criteria
2. Urinary tract anomalies, stricture or obstruction;
3. Calculus in diverticulum;
4. Severe hydronephosis;
5. Combined with acute urinary tract infection;
6. Coagulation abnormalities;
7. Morbid obesity(BMI\>35kg/m2);
8. Patients with ureteral stent;
9. Stones aren't fragment successfully, or the diameter of at least one fragment is more than 6mm ;
18 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Guohua Zeng
Vice President of the Hospital
Principal Investigators
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Guohua Zeng, PH.D and M.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical
Locations
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Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Guohua Zeng, Ph.D and M.D
Role: primary
Other Identifiers
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MRER(53)2015
Identifier Type: -
Identifier Source: org_study_id