- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07601932
Patient Positioning for Treatment of Proximal Ureteral Stones
Optimal Patient Positioning and Strategy for the Treatment of Proximal Ureteral Stones
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Ureteroscopy has become a primary modality for the management of ureteral and renal calculi due to its high efficacy, minimally invasive nature, and favorable safety profile. Despite advances in flexible ureteroscopy, laser lithotripsy, and access technologies, proximal ureteral stones remain technically challenging, largely due to their tendency to migrate retrograde into the kidney, leading to prolonged operative time, increased need for flexible ureteroscopy, and lower procedural efficiency.
Stone retropulsion is influenced by laser energy, irrigation flow, ureteral anatomy, and gravitational forces. Several mechanical and laser-based strategies have been explored to mitigate migration, though results have been variable. Patient positioning represents a simple and cost-neutral intervention that may alter stone behavior intraoperatively without requiring additional devices.
Reverse Trendelenburg positioning has recently been shown to reduce proximal stone migration and improve operative efficiency during ureteroscopic treatment of ureteral stones. In a randomized controlled trial, patients positioned in reverse Trendelenburg experienced lower rates of retropulsion, reduced need for conversion to flexible ureteroscopy, and shorter operative times compared with standard positioning. However, this study included stones across multiple ureteral segments and did not focus specifically on proximal ureteral stones, which may have distinct anatomical and migration characteristics.
Conversely, T-tilt positioning has been investigated in the context of intrarenal stone treatment. Prior randomized evidence demonstrated that T-tilt positioning during retrograde intrarenal surgery resulted in higher stone-free rates, likely due to improved gravitational alignment of calyces and enhanced fragment clearance. These findings suggest that positioning may also optimize intrarenal lithotripsy efficiency once stones migrate into the kidney.
For proximal ureteral stones, two competing operative strategies are commonly used in clinical practice: (1) in situ ureteral treatment with efforts to prevent migration, potentially optimized by reverse Trendelenburg positioning, or (2) intentional pushback of the stone into the kidney followed by intrarenal lithotripsy under positioning conditions favorable for fragment clearance, such as T-tilt.
The decision to use one strategy over another is based on surgeon preference. Currently, there are no guidelines or standards favoring either approach. To date, no randomized study has directly compared these two positioning-based strategies for proximal ureteral stones. Given that operative time is strongly associated with anesthesia exposure, procedural cost, complication risk, and resource utilization, it represents a clinically meaningful and objective primary endpoint to evaluate procedural efficiency between approaches.
This study seeks to address an important gap in endourologic practice by determining the optimal positioning strategy for proximal ureteral stone management, with the goal of improving operative efficiency, reducing procedural burden, and informing evidence-based surgical decision-making.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mantu Gupta, MD
- Numero di telefono: 212-241-1272
- Email: Mantu.gupta@mountsinai.org
Backup dei contatti dello studio
- Nome: Blair Gallante, MPH
- Numero di telefono: 212-241-1272
- Email: blair.gallante@mountsinai.org
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10019
- Reclutamento
- Mount Sinai West
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Investigatore principale:
- Mantu Gupta, MD
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Contatto:
- Mantu Gupta, MD
- Numero di telefono: 212-241-1272
- Email: Mantu.gupta@mountsinai.org
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Contatto:
- Blair Gallante, MPH
- Numero di telefono: 212-241-1272
- Email: blair.gallante@mountsinai.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total operative time
Lasso di tempo: Immediately postoperatively on the day of surgery
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Operative time will be used to compare procedural efficiency
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Immediately postoperatively on the day of surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of participants stone-free
Lasso di tempo: From Week 4 to Week 6 postoperatively
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Proportion of participants without residual stone fragments on postoperative CT imaging
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From Week 4 to Week 6 postoperatively
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Proportion of procedures requiring additional equipment or procedural maneuvers
Lasso di tempo: Immediately after completion of surgery on the day of procedure
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Proportion of procedures requiring additional equipment or procedural maneuvers beyond the initially planned operative strategy to complete stone treatment
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Immediately after completion of surgery on the day of procedure
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Proportion of strategy failure
Lasso di tempo: Assessed immediately at completion of surgery on the day of procedure
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Proportion of cases in which the randomized operative strategy could not be successfully executed intraoperatively
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Assessed immediately at completion of surgery on the day of procedure
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Incidence of Complications
Lasso di tempo: Through postoperative day 30
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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.
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Through postoperative day 30
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY-26-00168
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