Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2022-07-01
2023-08-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Delphi Questionnaire
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.
Interventions
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Delphi Questionnaire
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Hooman Djaladat
Professor of Clinical Urology
Principal Investigators
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Hooman Djaladat, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Hooman Djaladat
Los Angeles, California, United States
Countries
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References
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Munoz JJ, Ellison LM. Upper tract urothelial neoplasms: incidence and survival during the last 2 decades. J Urol. 2000 Nov;164(5):1523-5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UP-22-0032
Identifier Type: -
Identifier Source: org_study_id