NCT02734914

Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure

Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Affiliated Ganzhou Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.

Detailed description

Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi \< 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result. However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy. Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.

Conditions

• Renal Calculi

Interventions

Type	Name	Description
DEVICE	SF-URS with automatic control of RPP	A new F-URS monitoring and control of RPP using intelligent pressure control device
DEVICE	conventional F-URS	Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-07-01
• Completion: 2018-08-01
• First posted: 2016-04-12
• Last updated: 2016-04-12