Clinical Trial: Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy in Renal Calculi

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy for the Treatment of Renal Calculi < 3 cm - Efficacity Prospective Randomized Multicentre Trial

Brief Summary: This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.

Detailed Summary:

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, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution.

Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach.

This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.


Sponsor: Ling Li, MD

Current Primary Outcome: Stone clearance [ Time Frame: 12 weeks post-operatively ]

Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stone clearance [ Time Frame: One day post-operatively ]
    Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%
  • Complication rates [ Time Frame: Within 12 weeks after surgery ]
    Number of participants undergo tf-URS or f-URS surgeries suffer complications associated with the surgery (i.e. painess(NRS≥4), hematuria, T≥38℃, serum WBC≥12×〖10〗^9/L ,serum WBC<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%
  • Endoscope deflection loss rates [ Time Frame: intraoperative ]
    Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss>10%/Total number of ureterorenoscope or ureterosocpe used *100%
  • Endoscope Leakage rates [ Time Frame: intraoperative ]
    Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with leakage of the working channel or the outer shaft/times of the ureterorenoscope or ureterosocpe used *100%
  • Endoscope black dots rates [ Time Frame: intraoperative ]
    Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with black dots on endoscopic images/times of ureterorenoscope or ureterosocpe used *100%


Original Secondary Outcome: Same as current

Information By: Changhai Hospital

Dates:
Date Received: February 12, 2015
Date Started: April 2015
Date Completion: June 2015
Last Updated: April 22, 2015
Last Verified: April 2015