Patient Positioning for Treatment of Proximal Ureteral Stones

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07601932
Status
Recruiting

Conditions

  • Ureteral Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Reverse Trendelenburg Position — PROCEDURE
    Patients will be positioned in reverse Trendelenburg at a 20 degree incline with the use of a digital protractor. Lithotripsy will be performed within the ureter with attempts to prevent proximal migration and until all fragments are removed.
  • T-Tilt Position — PROCEDURE
    Stone will be intentionally relocated into the kidney when feasible, followed by intrarenal lithotripsy in T-tilt position. In the T-tilt position the table is angled 15-degree Trendelenburg and 15-degree airplane away from the surgical side kidney with the use of a digital protractor. This allows fragments to rest in a superior and medial position away from the lower pole to facilitate removal.

Study Details

Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Reverse Trendelenburg positioning has been shown to reduce proximal stone migration and operative time in ureteral stones, while the T-tilt position improves intrarenal stone clearance. The optimal strategy for proximal ureteral stones (treating stones in situ using reverse Trendelenburg versus pushing stones into the kidney followed by intrarenal treatment in T-tilt) remains unknown. This randomized controlled trial compares these two strategies, with primary focus on operative time as a measure of procedural efficiency. A total of 54 patients (27 per arm) will be enrolled at Mount Sinai West.

Key Dates

Start date
May 21, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Reverse Trendelenburg Position
    Participants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.
  • Active Comparator: T-Tilt Position
    Participants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.

Primary Outcome Measure

Total operative time [ Time Frame: Immediately postoperatively on the day of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai WestNew YorkNew York10019
Mantu Gupta, MD
212-241-1272
Blair Gallante, MPH
212-241-1272
Mantu Gupta, MD (PRINCIPAL_INVESTIGATOR)

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