Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-28 @ 7:45 PM
Study NCT ID:
NCT05373966
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Radical Nephroureterectomy Delphi Consensus
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Delphi Consensus on Robotic Radical Nephroureterectomy Curriculum
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to develop a structured training program for robotic radical nephroureterectomy (RNU), based on a Delphi consensus among a panel of experts in this field. A standard questionnaire will be used to obtain experts' opinions on the training steps for robotic RNU.
Detailed Description:
Upper tract urothelial carcinoma (UTUC) is an uncommon, yet biologically heterogeneous disease that accounts for 5-10% of all urothelial tumors. Radical nephroureterectomy (RNU) with bladder cuff excision is the gold standard for the treatment of UTUC patients. While this procedure is traditionally performed via an open approach, minimally invasive techniques have been used more frequently in recent years. A population-based analysis recently reported an increasing trend in the utilization of robotic RNU from 29% in 2010 to 53% in 2016. Robotic approach not only provides better visualization and optimal exposure during RNU but is also associated with improved perioperative outcomes compared to the open method.
Previous studies have shown that patients treated during the learning phase of a surgeon are at risk of inferior outcomes relative to those treated by experienced surgeons. To overcome such suboptimal outcomes, specific training curriculums have been proposed for some urologic procedures, such as robotic radical prostatectomy, radical cystectomy, and partial nephrectomy. Nevertheless, despite the widespread use of robot for RNU in recent years, no training program is currently available to assist urology residents during their learning process.
This study will provide the first training program for robotic RNU. This curriculum can help to track the progression of the trainee and ensure that defined benchmarks of skills will be reached before the trainee progresses to the next level of difficulty. In addition, it will ultimately improve patients' safety during the learning phase of the urologists.
Previous studies have shown that patients treated during the learning phase of a surgeon are at risk of inferior outcomes relative to those treated by experienced surgeons. To overcome such suboptimal outcomes, specific training curriculums have been proposed for some urologic procedures, such as robotic radical prostatectomy, radical cystectomy, and partial nephrectomy. Nevertheless, despite the widespread use of robot for RNU in recent years, no training program is currently available to assist urology residents during their learning process.
This study will provide the first training program for robotic RNU. This curriculum can help to track the progression of the trainee and ensure that defined benchmarks of skills will be reached before the trainee progresses to the next level of difficulty. In addition, it will ultimately improve patients' safety during the learning phase of the urologists.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: