Educational ProblemsPROVESANCT04786834
PBP Versus Halsted's Model: the PROVESA Trial
A study testing Vesico urethral anastomosis on chicken model in people with Educational Problems, run by Stefano Puliatti at 1 site in Belgium.
Trial summary
This randomized controlled trial aims to compare the effectiveness of Halsted's apprenticeship approach to training with the PBP approach for teaching the robotic suturing of a VUA on a chicken model. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Vesico urethral anastomosis on chicken model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Jul 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- recently accepted, first or second year residents gynecology and obstetrics (n=12), urology (n=12) and general surgery (n=12). Novice in robotic surgery.
Who cannot join
- Any robotic experience
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proficiency Based Progression Training Versus the Halsted's Model for a Robotic Vesico-urethral Anastomosis on an Avian Tissue Model: a Prospective, Randomized, Multicenter and Blinded Clinical Trial: the PROVESA Trial
This randomized controlled trial aims to compare the effectiveness of Halsted's apprenticeship approach to training with the PBP approach for teaching the robotic suturing of a VUA on a chicken model.
Read the detailed description
In a prospective, randomized and blinded study robotic naïve (urology (n = 12), surgery (n = 12) and gynecology (n = 12)) residents (n = 36) from the KU Leuven and University of Gent residency training programs will be randomized (in equal discipline numbers) to Traditional Halstedian apprenticeship type training or proficiency based progression (PBP) training to learn to perform a vesico-urethral anastomosis (VUA) on a chicken model. Both groups will receive the same e-learning (on how to perform the VUA on the chicken model) and skills laboratory robotic training curriculum. The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., from e-learning to the skills lab). The PBP group will also have a defined benchmark to demonstrate before training is deemed completed. The Traditional trained group will train in the same skills laboratory for a case-matched period of time as the PBP group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks or metric-based feedback. Both groups will be required to perform a VUA on the chicken model before skills training proper and at the end of training. Investigators will be trained in pairs to assess VUA performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability > 0.8). They will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order.
H1 It is hypothesized that implementation of PBP training in teaching the robotic suturing of VUA leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to Halsted's method.
- Conditions
- Educational Problems
- Being tested
- Vesico urethral anastomosis on chicken model
- Keywords
- surgery, robotics, training, vesico-urethral anastomosis, Proficiency Based Progression, Basic skills training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vesico urethral anastomosis on chicken modelProcedure or surgery
Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system
| Study group | Role | What they receive |
|---|---|---|
| Traditional training group | Active comparator | Trainees in the Traditional trained group will be trained according to the traditional approach of 'See one, do one, teach one' principle. Trainees will have an e-learning didactic component (specifically on the anatomy \& physiology of the procedure, clinical aspects of the procedure, published evidence etc) which they must complete before training by a procedure expert. On completion of the e-learning module they will complete a summative assessment of their knowledge. They will then be shown how and then trained to suture and tie knots using the robot. The VUA will be demonstrated initially by an expert and who will then proctor the trainees in the same technique for repeated training trials., i.e., repeated practice for a period of time matched to the PBP group. Receives: Procedure: Vesico urethral anastomosis on chicken model |
| Proficiency based progression (PBP) training group: a new training methodology | Experimental | Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge before continuing to the surgical training. Their knowledge will be assessed in a formative and summative fashion. After their initial VUA assessment, procedure-specific and validated procedure metrics will be used to teach the students the steps of the procedure, as well as the correct (and incorrect) way to perform the procedure. The metrics will be used to give them performance feedback with specific advice on how they might improve their performance, i.e., deliberate practice. Receives: Procedure: Vesico urethral anastomosis on chicken model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical proficiency level determined by objectively assessed, validated, binary performance operative metrics. Comparison between PBP training versus traditional training for a robotic suturing and knot tying task.
The aim of this paper is to report the main outcomes of the PROVESA trial without emphasizing the interspecialty differences. The investigators will however emphasize its methodology, the fact that is well controlled and multicentric. Differences in proficiency level, assessed by binary performance metrics based assessment of a robotic suturing and knot tying task, will be reported.
Measured: 1 year
Secondary outcomes (5)
Cross-specialty differences in surgical proficiency levels, assessed by objectively assessed, validated, binary performance operative metrics, for a robotic suturing and knot tying task.
Surgical skill is often thought to be associated to surgical discipline. The aim of this study is to compare the objectively assessed training outcomes of different surgical disciplines (Surgery, Gynecology/obstetrics and Urology) performing the robotic suturing of a vesico-urethral anastomosis (VUA) on a chicken model. Participants were trained according to a traditional versus a proficiency based progression methodology and were assessed by the use of validated, binary performance operative metrics.
Measured: 1 year
Difference in interrater reliability for metrics-based scoring determined by objectively assessed, validated, binary performance operative metrics versus GEARS-based scoring of a robotic suturing and knot tying task.
Nowadays, different methods are used to assess surgical performance. One of the most commonly used methods is the GEARS (Global Evaluative Assessment of Robotic Skills). This is, however, a qualitative scoring method which uses a Likert scale for scoring and which might be prone to poor interrater reliability and subjectiveness.
The aim of this paper will be to report the interrater reliability of both scoring methods and the correlation between each other. Hypothesis is that interrater reliability will be superior for performance metrics. The investigators will try to answer the question which is the best tool to assess surgical performance.
Measured: 2 years
Trainee's satisfaction as assessed by questionnaire with Likert scale. Does it influence outcome of surgical training? Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
Satisfaction of a surgical trainee is often thought to be key for training quality and a predictor of good outcome of surgical training. At the end of the PROVESA, all participants were asked to complete an online questionnaire where their satisfaction with the adopted training method was asked for using a Likert scale.
Hypothesis is that trainee's satisfaction does NOT correlate with training outcome and that satisfaction is NOT a good determinator of training quality.
Measured: 2 years
Correlation between live and video-based scoring of surgical performance
Surgical performance is often assessed live during surgery. However, one might miss specific details of performance. A possible answer to this query lies in video-based scoring of a surgical task. However, does video-based scoring reflects the same surgical quality? Moreover, one could question the ethical aspect of non-live scoring of surgical performance.
In the PROVESA trial, all surgical tasks were scored live and video-based afterwards. The correlation in metrics-based performance scores between live and video-based assessment will be investigated.
Hypothesis is that there will be no differences. The investigators will try to answer the question which scoring method will give the trainee the highest chance of reaching proficiency?
Measured: 2 years
Reporting the outcome of the e-learning scores from an online proficiency questionnaire on an online learning platform. Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
During the PROVESA trial, all participants had to do an online assessment. This was done on an online learning platform using a questionnaire. A proficiency benchmark was set based on the mean score of experts on the same questionnaire.
The PBP group needed to do this after doing an online curriculum during which the operative metrics were explained. In order to move forward to the clinical training in the lab, they had to show proficiency on the test by reaching a pre-defined benchmark.
The Control group needed to do the online assessment after their day of training and after performing the final VUA. The investigators noted a significant correlation between the score on the online assessment and the number of metrics-based performance errors. The lower the score on the online test, the more performance errors they made.
The aim of this paper will be to stipulate the importance of e-learning and online scoring and its correlation with surgical performance.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start27 Jul 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefano Puliatti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Puliatti, Orsi Academy
- Investigators
- Ruben De Groote, MD, Principal investigator, Orsi Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786834
- Sponsor's protocol ID
- PROVESA
- Acronym
- PROVESA
- Status last verified
- Mar 2021
- First submitted
- 9 Jan 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pellegrini CA. Surgical education in the United States: navigating the white waters. Ann Surg. 2006 Sep;244(3):335-42. doi: 10.1097/01.sla.0000234800.08200.6c. No abstract available.
PubMed 16926559Cuschieri A. Whither minimal access surgery: tribulations and expectations. Am J Surg. 1995 Jan;169(1):9-19. doi: 10.1016/s0002-9610(99)80104-4. No abstract available.
PubMed 7818004Gallagher AG. Metric-based simulation training to proficiency in medical education:- what it is and how to do it. Ulster Med J. 2012 Sep;81(3):107-13.
PubMed 23620606Gallagher AG, Ritter EM, Champion H, Higgins G, Fried MP, Moses G, Smith CD, Satava RM. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005 Feb;241(2):364-72. doi: 10.1097/01.sla.0000151982.85062.80.
PubMed 15650649Breen D, O'Brien S, McCarthy N, Gallagher A, Walshe N. Effect of a proficiency-based progression simulation programme on clinical communication for the deteriorating patient: a randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e025992. doi: 10.1136/bmjopen-2018-025992.
PubMed 31289064Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.
PubMed 30327396Angelo RL, Ryu RK, Pedowitz RA, Beach W, Burns J, Dodds J, Field L, Getelman M, Hobgood R, McIntyre L, Gallagher AG. A Proficiency-Based Progression Training Curriculum Coupled With a Model Simulator Results in the Acquisition of a Superior Arthroscopic Bankart Skill Set. Arthroscopy. 2015 Oct;31(10):1854-71. doi: 10.1016/j.arthro.2015.07.001. Epub 2015 Sep 2.
PubMed 26341047Van Sickle KR, Ritter EM, Baghai M, Goldenberg AE, Huang IP, Gallagher AG, Smith CD. Prospective, randomized, double-blind trial of curriculum-based training for intracorporeal suturing and knot tying. J Am Coll Surg. 2008 Oct;207(4):560-8. doi: 10.1016/j.jamcollsurg.2008.05.007. Epub 2008 Jul 14.
PubMed 18926460Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA 3rd, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007 Jun;193(6):797-804. doi: 10.1016/j.amjsurg.2006.06.050.
PubMed 17512301Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4. doi: 10.1097/00000658-200210000-00008.
PubMed 12368674Vanlander AE, Mazzone E, Collins JW, Mottrie AM, Rogiers XM, van der Poel HG, Van Herzeele I, Satava RM, Gallagher AG. Orsi Consensus Meeting on European Robotic Training (OCERT): Results from the First Multispecialty Consensus Meeting on Training in Robot-assisted Surgery. Eur Urol. 2020 Nov;78(5):713-716. doi: 10.1016/j.eururo.2020.02.003. Epub 2020 Feb 21.
PubMed 32089358Cacciamani G, De Marco V, Siracusano S, De Marchi D, Bizzotto L, Cerruto MA, Motton G, Porcaro AB, Artibani W. A new training model for robot-assisted urethrovesical anastomosis and posterior muscle-fascial reconstruction: the Verona training technique. J Robot Surg. 2017 Jun;11(2):123-128. doi: 10.1007/s11701-016-0626-4. Epub 2016 Jul 20.
PubMed 27440232Santos DRD, Calvo FC, Feijo DH, Araujo NP, Teixeira RKC, Yasojima EY. New training model using chickens intestine for pediatric intestinal anastomosis. Acta Cir Bras. 2019 Sep 16;34(7):e201900709. doi: 10.1590/s0102-865020190070000009.
PubMed 31531529Sotelo RJ, Astigueta JC, Carmona OJ, De Andrade RJ, Moreira OE. Chicken gizzard: a new training model for laparoscopic urethrovesical anastomosis. Actas Urol Esp. 2009 Nov;33(10):1083-7. doi: 10.1016/s0210-4806(09)73185-7. English, Spanish.
PubMed 20096178Ericsson KA. Towards a science of the acquisition of expert performance in sports: Clarifying the differences between deliberate practice and other types of practice. J Sports Sci. 2020 Jan;38(2):159-176. doi: 10.1080/02640414.2019.1688618. Epub 2019 Nov 12.
PubMed 31718526
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proficiency Based Progression Training Versus the Halsted's Model for a Robotic Vesico-urethral Anastomosis on an Avian Tissue Model: a Prospective, Randomized, Multicenter and Blinded Clinical Trial: the PROVESA Trial
- ClinicalTrials.gov ID
- NCT04786834
- Acronym / sponsor ID
- PROVESA / PROVESA
- Conditions
- Educational Problems
- Keywords
- surgery, robotics, training, vesico-urethral anastomosis, Proficiency Based Progression, Basic skills training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Stefano PuliattiUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare the effectiveness of Halsted's apprenticeship approach to training with the PBP approach for teaching the robotic suturing of a VUA on a chicken model.
Detailed description
In a prospective, randomized and blinded study robotic naïve (urology (n = 12), surgery (n = 12) and gynecology (n = 12)) residents (n = 36) from the KU Leuven and University of Gent residency training programs will be randomized (in equal discipline numbers) to Traditional Halstedian apprenticeship type training or proficiency based progression (PBP) training to learn to perform a vesico-urethral anastomosis (VUA) on a chicken model. Both groups will receive the same e-learning (on how to perform the VUA on the chicken model) and skills laboratory robotic training curriculum. The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., from e-learning to the skills lab). The PBP group will also have a defined benchmark to demonstrate before training is deemed completed. The Traditional trained group will train in the same skills laboratory for a case-matched period of time as the PBP group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks or metric-based feedback. Both groups will be required to perform a VUA on the chicken model before skills training proper and at the end of training. Investigators will be trained in pairs to assess VUA performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability > 0.8). They will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order.
H1 It is hypothesized that implementation of PBP training in teaching the robotic suturing of VUA leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to Halsted's method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional training group | Active comparator | Procedure: Vesico urethral anastomosis on chicken modelTrainees in the Traditional trained group will be trained according to the traditional approach of 'See one, do one, teach one' principle. Trainees will have an e-learning didactic component (specifically on the anatomy \& physiology of the procedure, clinical aspects of the procedure, published evidence etc) which they must complete before training by a procedure expert. On completion of the e-learning module they will complete a summative assessment of their knowledge. They will then be shown how and then trained to suture and tie knots using the robot. The VUA will be demonstrated initially by an expert and who will then proctor the trainees in the same technique for repeated training trials., i.e., repeated practice for a period of time matched to the PBP group. |
| Proficiency based progression (PBP) training group: a new training methodology | Experimental | Procedure: Vesico urethral anastomosis on chicken modelParticipants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge before continuing to the surgical training. Their knowledge will be assessed in a formative and summative fashion. After their initial VUA assessment, procedure-specific and validated procedure metrics will be used to teach the students the steps of the procedure, as well as the correct (and incorrect) way to perform the procedure. The metrics will be used to give them performance feedback with specific advice on how they might improve their performance, i.e., deliberate practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recently accepted, first or second year residents gynecology and obstetrics (n=12), urology (n=12) and general surgery (n=12). Novice in robotic surgery.
Key exclusion criteria (1 listed)
- Any robotic experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vesico urethral anastomosis on chicken modelPerformance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system | Procedure or surgery | Proficiency based progression (PBP) training group: a new training methodology, Traditional training group |
Primary outcome
Surgical proficiency level determined by objectively assessed, validated, binary performance operative metrics. Comparison between PBP training versus traditional training for a robotic suturing and knot tying task.
Time frame: 1 year
The aim of this paper is to report the main outcomes of the PROVESA trial without emphasizing the interspecialty differences. The investigators will however emphasize its methodology, the fact that is well controlled and multicentric. Differences in proficiency level, assessed by binary performance metrics based assessment of a robotic suturing and knot tying task, will be reported.
5 secondary outcomes
Cross-specialty differences in surgical proficiency levels, assessed by objectively assessed, validated, binary performance operative metrics, for a robotic suturing and knot tying task.
Time frame: 1 year
Difference in interrater reliability for metrics-based scoring determined by objectively assessed, validated, binary performance operative metrics versus GEARS-based scoring of a robotic suturing and knot tying task.
Time frame: 2 years
Trainee's satisfaction as assessed by questionnaire with Likert scale. Does it influence outcome of surgical training? Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
Time frame: 2 years
Correlation between live and video-based scoring of surgical performance
Time frame: 2 years
Reporting the outcome of the e-learning scores from an online proficiency questionnaire on an online learning platform. Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Results publication: PubMed 16926559Pellegrini CA. Surgical education in the United States: navigating the white waters. Ann Surg. 2006 Sep;244(3):335-42. doi: 10.1097/01.sla.0000234800.08200.6c. No abstract available.
- Results publication: PubMed 7818004Cuschieri A. Whither minimal access surgery: tribulations and expectations. Am J Surg. 1995 Jan;169(1):9-19. doi: 10.1016/s0002-9610(99)80104-4. No abstract available.
- Results publication: PubMed 23620606Gallagher AG. Metric-based simulation training to proficiency in medical education:- what it is and how to do it. Ulster Med J. 2012 Sep;81(3):107-13.
- Results publication: PubMed 15650649Gallagher AG, Ritter EM, Champion H, Higgins G, Fried MP, Moses G, Smith CD, Satava RM. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005 Feb;241(2):364-72. doi: 10.1097/01.sla.0000151982.85062.80.
- Results publication: PubMed 31289064Breen D, O'Brien S, McCarthy N, Gallagher A, Walshe N. Effect of a proficiency-based progression simulation programme on clinical communication for the deteriorating patient: a randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e025992. doi: 10.1136/bmjopen-2018-025992.
- Results publication: PubMed 30327396Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.
- Results publication: PubMed 26341047Angelo RL, Ryu RK, Pedowitz RA, Beach W, Burns J, Dodds J, Field L, Getelman M, Hobgood R, McIntyre L, Gallagher AG. A Proficiency-Based Progression Training Curriculum Coupled With a Model Simulator Results in the Acquisition of a Superior Arthroscopic Bankart Skill Set. Arthroscopy. 2015 Oct;31(10):1854-71. doi: 10.1016/j.arthro.2015.07.001. Epub 2015 Sep 2.
- Results publication: PubMed 18926460Van Sickle KR, Ritter EM, Baghai M, Goldenberg AE, Huang IP, Gallagher AG, Smith CD. Prospective, randomized, double-blind trial of curriculum-based training for intracorporeal suturing and knot tying. J Am Coll Surg. 2008 Oct;207(4):560-8. doi: 10.1016/j.jamcollsurg.2008.05.007. Epub 2008 Jul 14.
- Results publication: PubMed 17512301Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA 3rd, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007 Jun;193(6):797-804. doi: 10.1016/j.amjsurg.2006.06.050.
- Results publication: PubMed 12368674Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4. doi: 10.1097/00000658-200210000-00008.
- Results publication: PubMed 32089358Vanlander AE, Mazzone E, Collins JW, Mottrie AM, Rogiers XM, van der Poel HG, Van Herzeele I, Satava RM, Gallagher AG. Orsi Consensus Meeting on European Robotic Training (OCERT): Results from the First Multispecialty Consensus Meeting on Training in Robot-assisted Surgery. Eur Urol. 2020 Nov;78(5):713-716. doi: 10.1016/j.eururo.2020.02.003. Epub 2020 Feb 21.
- Results publication: PubMed 27440232Cacciamani G, De Marco V, Siracusano S, De Marchi D, Bizzotto L, Cerruto MA, Motton G, Porcaro AB, Artibani W. A new training model for robot-assisted urethrovesical anastomosis and posterior muscle-fascial reconstruction: the Verona training technique. J Robot Surg. 2017 Jun;11(2):123-128. doi: 10.1007/s11701-016-0626-4. Epub 2016 Jul 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben De Groote, MD principal investigator
Orsi Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vesico urethral anastomosis on chicken model in people with Educational Problems, run by Stefano Puliatti at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical proficiency level determined by objectively assessed, validated, binary performance operative metrics. Comparison between PBP training versus traditional training for a robotic suturing and knot tying task. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04786834, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.