Robotic Radical Nephroureterectomy Delphi Consensus

NCT05373966 | Completed

• 1 other identifier: UP-22-0032
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Consensus Development

Outcome Measures

Primary Outcomes (1)

• Degree of consensus

  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

  12 months

Study Arms (1)

Delphi Panel

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.

Other: Delphi Questionnaire

Interventions

Delphi Questionnaire OTHER

An invitation email, including a link to the survey, will be sent to the panel of experts in the field of robotic RNU. The Delphi questionnaire will be administered via Welphi.com. In the first survey, panel members will outline the training program for robotic RNU. In subsequent surveys, the expert panel will evaluate the modified criteria using a 1 to 5-point Likert scale with space provided for suggested edits and comments. Multiple rounds will be conducted until consensus is reached. After each round of Likert responses, the study team will calculate the agreement and distribution of responses. Likert responses will be dichotomized with positive values indicating agreement and neutral or negative values indicating disagreement. For the questions that do not reach a consensus of more than 80% in the first round or need further explanation, additional rounds of the survey may be performed.

Delphi Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A team of experts in the field of robotic RNU, who are identified according to surgical experience, research and academic interest, expertise in running training courses, and participation in live-surgery cases.

You may qualify if:

• Experts in the field of robotic RNU

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Hooman Djaladat

Los Angeles, California, 90089, United States

Location

Related Publications (12)

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  PMID: 11025695 BACKGROUND

• Roupret M, Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Cowan NC, Dominguez-Escrig JL, Gontero P, Hugh Mostafid A, Palou J, Peyronnet B, Seisen T, Soukup V, Sylvester RJ, Rhijn BWGV, Zigeuner R, Shariat SF. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: 2020 Update. Eur Urol. 2021 Jan;79(1):62-79. doi: 10.1016/j.eururo.2020.05.042. Epub 2020 Jun 24.

  PMID: 32593530 BACKGROUND

• Kenigsberg AP, Smith W, Meng X, Ghandour R, Rapoport L, Bagrodia A, Lotan Y, Woldu SL, Margulis V. Robotic Nephroureterectomy vs Laparoscopic Nephroureterectomy: Increased Utilization, Rates of Lymphadenectomy, Decreased Morbidity Robotically. J Endourol. 2021 Mar;35(3):312-318. doi: 10.1089/end.2020.0496. Epub 2020 Nov 16.

  PMID: 33081512 BACKGROUND

• Lee H, Kim HJ, Lee SE, Hong SK, Byun SS. Comparison of oncological and perioperative outcomes of open, laparoscopic, and robotic nephroureterectomy approaches in patients with non-metastatic upper-tract urothelial carcinoma. PLoS One. 2019 Jan 8;14(1):e0210401. doi: 10.1371/journal.pone.0210401. eCollection 2019.

  PMID: 30620766 BACKGROUND

• Thompson JE, Egger S, Bohm M, Haynes AM, Matthews J, Rasiah K, Stricker PD. Superior quality of life and improved surgical margins are achievable with robotic radical prostatectomy after a long learning curve: a prospective single-surgeon study of 1552 consecutive cases. Eur Urol. 2014 Mar;65(3):521-31. doi: 10.1016/j.eururo.2013.10.030. Epub 2013 Oct 31.

  PMID: 24287319 BACKGROUND

• Thompson JE, Egger S, Bohm M, Siriwardana AR, Haynes AM, Matthews J, Scheltema MJ, Stricker PD. Superior Biochemical Recurrence and Long-term Quality-of-life Outcomes Are Achievable with Robotic Radical Prostatectomy After a Long Learning Curve-Updated Analysis of a Prospective Single-surgeon Cohort of 2206 Consecutive Cases. Eur Urol. 2018 May;73(5):664-671. doi: 10.1016/j.eururo.2017.11.035. Epub 2017 Dec 19.

  PMID: 29273404 BACKGROUND

• Veccia A, Carbonara U, Djaladat H, Mehazin R, Eun DD, Reese AC, Meng X, Uzzo R, Srivastava A, Porter J, Farrow JM, Jamil ML, Rosiello G, Tellini R, Mari A, Al-Qathani A, Rha KH, Wang L, Mastroianni R, Ferro M, De Cobelli O, Hakimi K, Crocerossa F, Ghoreifi A, Cacciamani G, Bhattu AS, Mottrie A, Abdollah F, Minervini A, Wu Z, Simone G, Derweesh I, Gonzalgo ML, Margulis V, Sundaram CP, Autorino R. Robotic vs Laparoscopic Nephroureterectomy for Upper Tract Urothelial Carcinoma: A Multicenter Propensity-Score Matched Pair "tetrafecta" Analysis (ROBUUST Collaborative Group). J Endourol. 2022 Jun;36(6):752-759. doi: 10.1089/end.2021.0587. Epub 2022 Feb 25.

  PMID: 35019760 BACKGROUND

• Veccia A, Carbonara U, Derweesh I, Mehrazin R, Porter J, Abdollah F, Mazzone E, Sundaram CP, Gonzalgo M, Mastroianni R, Ghoreifi A, Cacciamani GE, Patel D, Marcus J, Danno A, Steward J, Satish Bhattu A, Asghar A, Reese AC, Wu Z, Uzzo RG, Minervini A, Rha KH, Ferro M, Margulis V, Hampton LJ, Simone G, Eun DD, Djaladat H, Mottrie A, Autorino R. Single-stage Xi(R) robotic radical nephroureterectomy for upper tract urothelial carcinoma: surgical technique and outcomes. Minerva Urol Nephrol. 2022 Apr;74(2):233-241. doi: 10.23736/S2724-6051.21.04247-8. Epub 2021 Mar 29.

  PMID: 33781022 BACKGROUND

• Lovegrove C, Novara G, Mottrie A, Guru KA, Brown M, Challacombe B, Popert R, Raza J, Van der Poel H, Peabody J, Dasgupta P, Ahmed K. Structured and Modular Training Pathway for Robot-assisted Radical Prostatectomy (RARP): Validation of the RARP Assessment Score and Learning Curve Assessment. Eur Urol. 2016 Mar;69(3):526-35. doi: 10.1016/j.eururo.2015.10.048. Epub 2015 Nov 14.

  PMID: 26585582 RESULT

• Volpe A, Ahmed K, Dasgupta P, Ficarra V, Novara G, van der Poel H, Mottrie A. Pilot Validation Study of the European Association of Urology Robotic Training Curriculum. Eur Urol. 2015 Aug;68(2):292-9. doi: 10.1016/j.eururo.2014.10.025. Epub 2014 Oct 31.

  PMID: 25454612 RESULT

• Dell'Oglio P, Turri F, Larcher A, D'Hondt F, Sanchez-Salas R, Bochner B, Palou J, Weston R, Hosseini A, Canda AE, Bjerggaard J, Cacciamani G, Olsen KO, Gill I, Piechaud T, Artibani W, van Leeuwen PJ, Stenzl A, Kelly J, Dasgupta P, Wijburg C, Collins JW, Desai M, van der Poel HG, Montorsi F, Wiklund P, Mottrie A; ERUS Educational Working Group and the YAU Working Group on Robot-assisted Surgery. Definition of a Structured Training Curriculum for Robot-assisted Radical Cystectomy with Intracorporeal Ileal Conduit in Male Patients: A Delphi Consensus Study Led by the ERUS Educational Board. Eur Urol Focus. 2022 Jan;8(1):160-164. doi: 10.1016/j.euf.2020.12.015. Epub 2021 Jan 2.

  PMID: 33402314 RESULT

• Larcher A, De Naeyer G, Turri F, Dell'Oglio P, Capitanio U, Collins JW, Wiklund P, Van Der Poel H, Montorsi F, Mottrie A; ERUS Educational Working Group and the Young Academic Urologist Working Group on Robot-assisted Surgery. The ERUS Curriculum for Robot-assisted Partial Nephrectomy: Structure Definition and Pilot Clinical Validation. Eur Urol. 2019 Jun;75(6):1023-1031. doi: 10.1016/j.eururo.2019.02.031. Epub 2019 Apr 9.

  PMID: 30979635 RESULT

Study Officials

• Hooman Djaladat, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Urology

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 15, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)