Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)

Calculi Clinical Trial

Official title:

Effect Of Renal Residual Stones c Treated By External Physical Vibration Lithecbole(EPVL) In m Different Time n After Retrograde Intrarenal w Surgery(RIRS):At y Multi-center z Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890225
• Other study ID #: Zhengzhou
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Second Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely

Description:

To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of RIRS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1.Age of 18-75 years;

Exclusion Criteria:

1.Urinary tract anomalies, stricture or obstruction;

Related Conditions & MeSH terms

• Calculi

Intervention

Procedure:
• 3 days after
in 3 days after RIRS.
• 10days after
in10 days after RIRS.
• EPVL performed in30days after RIRS
Patients in Group C undergo EPVL in630days after RIRS.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from stone free rate(SFR) with different follow-up periods	Primary SFR is assessed by abdominal plain film (KUB)in different follow-up periods after operation. Stone-free status are defined as either the absence of any residual stone fragments.	Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Secondary	Extracorporeal physical vibration complications	Complication is defined as any adverse event occurred	Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.