NCT02645708

Brief Summary

The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely, hastening fragments clearance just only rely on traditional expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive therapy and changing body position. Therefore, researchers purpose to evaluate the effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual fragments after RIRS by prospective study of clinical trial, which will improve stone-free rate of residual fragments and benefit more patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 15, 2017

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

December 7, 2015

Last Update Submit

February 13, 2017

Conditions

Renal Calculi

Keywords

RIRSEPVLPDI(Percussion,Diuresis,Inversion)Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Change from stone free rate(SFR) with different follow-up periods

    Primary SFR is assessed by abdominal plain film （KUB）at2,3,5 week after operation. Stone-free status are defined as either the absence of any residual stone fragments.

    return hospital respectively in 2,3 and 5 week after RIRS

Secondary Outcomes (1)

  • extracorporeal physical vibration complications

    return hospital respectively in 2 ,3 and 5 weeks after RIRS

Study Arms (2)

Retrograde Intrarenal Surgery (RIRS)

OTHER

Patients in Group 1 undergo Retrograde Intrarenal Surgery

Procedure: Retrograde Intrarenal Surgery

EPVL after RIRS

OTHER

Patients in Group 2 undergo external physical vibration lithecbole after Retrograde Intrarenal Surgery. with the help of changing the position and direction of the extracorporeally physical vibration machine, the urinary stone was discharged from the urinary collecting system

Procedure: EPVL after RIRS

Interventions

Retrograde Intrarenal SurgeryPROCEDURE

Patients undergo Retrograde Intrarenal Surgery

Retrograde Intrarenal Surgery (RIRS)
EPVL after RIRSPROCEDURE

Patients in Group 2 undergo EPVL after RIRS

EPVL after RIRS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18-65 years;
  • The imaging demonstrate the presence of residual fragments in 1 week after RIRS;
  • Renal or upper ureteral calculus;
  • There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;
  • Stones are fragmented successfully on single session of RIRS, and the diameter of any of fragments is less than 4mm;
  • Normal renal function.

You may not qualify if:

  • Couldn't tolerate EPVL;
  • Urinary tract anomalies, stricture or obstruction;
  • Calculus in diverticulum;
  • Severe hydronephrosis;
  • Combined with acute urinary tract infection;
  • Coagulation abnormalities;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guohua Zeng, PH.D and M.D

    The First Affiliated Hospital of Guangzhou Medical

    STUDY CHAIR

Central Study Contacts

Guohua Zeng, PH.D and M.D

CONTACT

+86 13802916676gzgyzgh@vip.tom.com

Zhou Yang

CONTACT

+86 13416129917910074460@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of the Hospital

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 5, 2016

Study Start

August 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

February 15, 2017

Record last verified: 2016-08

Locations

CN(1)