Robotic Radical Nephroureterectomy Delphi Consensus

Completed

• Conditions: Consensus Development
• Interventions: Other: Delphi Questionnaire

• Registration Number: NCT05373966
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Study Start: 2022-07-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Experts in the field of robotic RNU

Exclusion Criteria

• Panelists who were not able to commit to all rounds of the modified Delphi process

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delphi Panel	Delphi Questionnaire	A team of experts in the field of robotic RNU will be invited to participate in the current survey. These experts are identified according to surgical experience, research and academic interest, expertise in running training courses, and participation in live-surgery cases.

Primary Outcome Measures

Name	Time	Method
Degree of consensus	12 months	The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement

Trial Locations

Locations (1)

Hooman Djaladat; 🇺🇸 Los Angeles, California, United States