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 — PROCEDUREPatients 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 — PROCEDUREStone 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 PositionParticipants 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 PositionParticipants 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
- Mantu Gupta, MD212-241-1272
- Blair Gallante, MPH212-241-1272
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10019 | Mantu Gupta, MD (PRINCIPAL_INVESTIGATOR) |
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