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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

RIRS has been widely adopted and used by urologists worldwide in the management of renal stones due to less invasiveness and efficacy, especially in small to moderate-sized renal stones. RIRS has several advantages over SWL for stones less than 2 cm diameter. Most importantly, removing the stone in one session without the need for other treatment modalities.

Furthermore, the application of RIRS has expanded to larger stones reaching up to 35 mm in some cases,in spite of not being the first line therapy for the larger stones. RIRS has advantages over the PCNL especially concerning complications. Namely lower or no bleeding events and the less invasiveness of RIRS.

Options for the treatment of intrarenal stones include fragmenting the stone then extracting large fragments using a basket or dusting the stone into very small fragments then leaving the (dust) to pass spontaneously.

The idea of dusting in RIRS emerges as a counterpart of the originally taught fragmentation and basketing of the stones. Aiming to reduce multiple entries and exits for the renal system and ultimately not requiring UAS or baskets during the surgery. Thus theoretically decreasing operative time and costs with the same SFRs, In addition to minimizing the risk of ureteral injury .

So there is a debate amongst surgeons whether to laser the stone to dust or fragment and retrieve intra-renal fragments. EAU guidelines on the surgical management of urolithiasis stated that dusting strategies should be limited to the treatment of large renal stones. Without clearly differentiating between dusting or fragmentation and basketing. Cho et al; favored fragmentation technique especially for large renal stones because the dust in dusting technique may affect visualization and obscure small stone fragments. But this was an opinion and not built on a direct comparative study.

Until now, there is no consensus on how to achieve optimal stone clearance once the primary stone is fragmented with lithotripsy. And to date, no prospective randomized study has addressed the practice of active extraction vs. spontaneous passage ;

Study Design

Related Conditions & MeSH terms

Urolithiasis

Clinical Trial Details

NCT number	NCT03207659
Study type	Interventional
Source	The First Affiliated Hospital of Guangzhou Medical University
Contact	Guohua Zeng, Ph.D and M.D.
Phone	+86 13802916676
Email	gzgyzgh@vip.sina.com
Status	Recruiting
Phase	N/A
Start date	August 1, 2017
Completion date	December 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.