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Initial Clinical Experience With a Novel Robotically Assisted Platform for Combined Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopic Lithotripsy.
Landman, Jaime; Clayman, Ralph V; Cumpanas, Andrei D; Patel, Roshan M; Jiang, Pengbo; Tano, Zachary E; Ali, Sohrab N; Sehgel, Nancy L; Caldwell, Jacob W; Gatti, Chiara; Petraiuolo, William J; Morris, Paul T; Desai, Mihir M.
Afiliação
  • Landman J; Department of Urology, University of California Irvine, Orange, California.
  • Clayman RV; Department of Urology, University of California Irvine, Orange, California.
  • Cumpanas AD; Department of Urology, University of California Irvine, Orange, California.
  • Patel RM; Department of Urology, University of California Irvine, Orange, California.
  • Jiang P; Department of Urology, University of California Irvine, Orange, California.
  • Tano ZE; Department of Urology, University of California Irvine, Orange, California.
  • Ali SN; Department of Urology, University of California Irvine, Orange, California.
  • Sehgel NL; Johnson & Johnson MedTech, Redwood City, California.
  • Caldwell JW; Johnson & Johnson MedTech, Redwood City, California.
  • Gatti C; Johnson & Johnson MedTech, Redwood City, California.
  • Petraiuolo WJ; Johnson & Johnson MedTech, Redwood City, California.
  • Morris PT; Johnson & Johnson MedTech, Redwood City, California.
  • Desai MM; Department of Urology, University of Southern California, Los Angeles, California.
J Urol ; 212(3): 483-493, 2024 Sep.
Article em En | MEDLINE | ID: mdl-39115125
ABSTRACT

PURPOSE:

We sought to evaluate the technical feasibility of performing a combined robotically assisted mini-percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy (URS) procedure by a single urologist using the MONARCH Platform, Urology (Johnson & Johnson MedTech, Redwood City, California). MATERIAL AND

METHODS:

In this prospective, first-in-human clinical trial, 13 patients underwent robotically-assisted PCNL for renal calculi at the University of California-Irvine, Department of Urology. Successful completion of the procedure was assessed as the primary endpoint. Postoperative adverse events were monitored for 30 days following the completion of the procedure. Stone ablation efficiency was evaluated on postoperative day 30 with low-dose 2-3 mm slice CT scans. Patients were classified according to the maximum length of their residual stone fragments as either absolute stone-free (Grade A), < 2 mm remnants (Grade B), or 2.1-4.0 mm remnants (Grade C).

RESULTS:

The combined robotic mini-PCNL and URS procedure was successfully completed in 12 of 13 procedures. No robotic device-related adverse events occurred. Preoperative stone burden was quantified by both maximum linear measurement (median 32.8 mm) as well as by CT-based volume (median 1645.9 mm3). Using the unique robotically assisted targeting system, percutaneous access was gained directly through the center of the renal papilla in a single pass in all cases. Median operative time was 187 minutes (range 83-383 minutes). On postoperative day 30, a 98.7% (range 72.9%-100.0%) volume reduction was achieved, with 5 Grade A (38.5%), 1 Grade B (7.7%), and 2 Grade C (15.4%). Three patients experienced complications (2 grade 1 and one grade 2 Clavien-Dindo).

CONCLUSIONS:

Our preliminary investigation demonstrates the safety, efficacy, and feasibility of a unique robotic-assisted combined mini-PCNL and URS platform.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cálculos Renais / Estudos de Viabilidade / Ureteroscopia / Procedimentos Cirúrgicos Robóticos / Nefrolitotomia Percutânea Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cálculos Renais / Estudos de Viabilidade / Ureteroscopia / Procedimentos Cirúrgicos Robóticos / Nefrolitotomia Percutânea Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article