Clinical Trials Directory

Trials / Unknown

UnknownNCT03207659

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
136 (estimated)
Sponsor
Guohua Zeng · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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

Conditions

Interventions

TypeNameDescription
PROCEDUREBasketing in RIRSTreament of renal stones by fragmentation of stone under direct vision through a flexible ureteroscope and then actively extracting them using a basket
PROCEDUREDusting in RIRSTreament of renal stones by dusting the stone under direct vision through a scope and then leaving them to pass spontaneously

Timeline

Start date
2017-08-01
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2017-07-05
Last updated
2018-08-07

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03207659. Inclusion in this directory is not an endorsement.