Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial

NCT03207659 | Unknown

• 1 other identifier: Dusting vs Basketing in RIRS
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of active basket extraction of fragments and stone dusting during the RIRS.

Conditions

Urolithiasis

Keywords

RIRS; Renal stones; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Stone free rate (SFR)

  To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist or uric acid it will be up to the discretion of the surgeon to order a CT to better delineate the presence of residual stones and their impact on the clinical management of that patient.

  4-6 weeks after surgery

Secondary Outcomes (2)

• Operating time

  intraoperatively

• Complication rates

  intraoperatively or 48h postoperatively

Study Arms (2)

Dusting

EXPERIMENTAL

small stones will be left to pass spontaneously.

Procedure: Dusting in RIRS

Basketing

EXPERIMENTAL

stones will be actively extracted.

Procedure: Basketing in RIRS

Interventions

Basketing in RIRS PROCEDURE

Treament of renal stones by fragmentation of stone under direct vision through a flexible ureteroscope and then actively extracting them using a basket

Basketing

Dusting in RIRS PROCEDURE

Treament of renal stones by dusting the stone under direct vision through a scope and then leaving them to pass spontaneously

Dusting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be a suitable operative candidate for RIRS
• Age ≥18 years
• Normal renal function
• ASA score Ⅰ and Ⅱ
• Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm

You may not qualify if:

• Pregnant subjects
• Uncorrected coagulopathy and active urinary tract infection (UTI)
• prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
• Patients who underwent transplant or urinary diversion.
• Congenital abnormalities.

Sponsors & Collaborators

• Guohua Zeng: lead

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

Urolithiasis; Nephrolithiasis

Interventions

Dust

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

Intervention Hierarchy (Ancestors)

Particulate Matter; Complex Mixtures

Study Officials

• Guohua Zeng, PH.D & MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohua Zeng, Ph.D and M.D.

CONTACT

+86 13802916676; gzgyzgh@vip.sina.com

Chao Cai, PH.D & MD

CONTACT

+86 13512780911; 673059209@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: July 5, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)