Patient Positioning for Treatment of Proximal Ureteral Stones
ConditionUreteral Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older.
Diagnosed with kidney stones and scheduled for fURS.
Stone burden > 1 cm and/or multiple stones will be eligible.
Able and willing to provide informed consent.
Disqualifiers
Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at the institution)
Untreated UTI
Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
Single stone < 1 cm
Trial design
Design model
Parallel
Treatments tested in this trial
Reverse Trendelenburg Position
Procedure/SurgeryPatients 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/SurgeryStone 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Reverse Trendelenburg PositionExperimental treatment 1 intervention
Group B: T-Tilt PositionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total operative time
Operative time will be used to compare procedural efficiency
Time frame
Immediately postoperatively on the day of surgerySecondary outcomes
1
Proportion of participants stone-free
Proportion of participants without residual stone fragments on postoperative CT imaging
Time frame
From Week 4 to Week 6 postoperatively2
Proportion of procedures requiring additional equipment or procedural maneuvers
Proportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment
Time frame
Immediately after completion of surgery on the day of procedure3
Proportion of strategy failure
Proportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively
Time frame
Assessed immediately at completion of surgery on the day of procedure4
Incidence of Complications
Incidence of postoperative complications, defined as any Clavien-Dindo complications, emergency department visits, or readmission related to the procedure. Outcome is recorded as the occurrence of a complication event (yes or no). Each participant is counted once, and the outcome is recorded as a binary variable indicating whether any of these events occurred or did not occur.
Time frame
Through postoperative day 30Sponsors and contacts
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Source ClinicalTrials.gov