Educational ProblemsT-RECNCT06147128
PBP vs Traditional Training: the T-REC Trial
An observational study of Educational Problems, run by Orsi Academy at 1 site in Belgium.
Trial summary
This randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is… 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?
- Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Aug 2023to 31 Jan 2024
- Phase
- Observational
- 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
Study population: Residents in urology, surgery and gynecology from Belgium universities (i.e. the KU Leuven and University of Gent residency training programs) from the first to the last year.
Who may be able to join
- recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery.
- Ability to perform a laparotomy
Who cannot join
- Any robotic experience with emergency undocking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proficiency Based Progression Training Versus Traditional Training During a Robotic Emergency Conversion Due to a Vessel Injury in a Simulated Setting: a Prospective, Randomized, Multicenter Clinical Trial: The T-REC Trial
This randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.
Read the detailed description
In a prospective, randomized and blinded study surgical residents (n = 48) from Belgium university (i.e. the Katholieke Universiteit [KU] Leuven and University of Gent residency training programs) will be enrolled and randomized to Traditional type training proficiency-based progression (PBP) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. Specifically, this study will include four independent arms, each employing different training methodologies for technical skills (TS) and non-technical skills (NTS).
Group 1 will receive standard training for both TS and NTS. Group 2 will receive PBP training for TS and standard training for NTS. Group 3 will receive standard training for TS and PBP training for NTS. Group 4 will receive PBP training for both TS and NTS.
All four group will receive the same e-learning on TS and NTS (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, TS and NTS). The Traditional trained group will train in the same 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.
Investigators will be trained in pairs to assess 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 TS and NTS for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.
- Conditions
- Educational Problems
- Being tested
- Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
- Keywords
- Training, Robotic surgery, Proficiency based progression, Emergency undocking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab modelProcedure or surgery
Also called Robotic emergency conversion
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Traditional Trained | Trainees in the Traditional trained group will have an e-learning didactic component (specifically on the steps 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 the trainees will complete a summative assessment of their knowledge. The trainees will then be shown how and then trained to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery task. The scenario will be demonstrated initially by an expert and who will then proctor the trainees in the same technique. Receives: Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model | |
| Experimental: PBP for Technical emergency undocking skills | 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 on TS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical skills. Receives: Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model | |
| Experimental: PBP for Non-Technical emergency undocking skills | 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 on NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of non-technical skills. Receives: Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model | |
| Experimental: PBP for Technical and Non-Technical emergency undocking skills | 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 on both TS and NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical and non-technical skills. Receives: Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.
Proficiency level will be determined by objectively assessed, validated, binary performance operative metrics where the proficiency benchmark is defined on the mean of the objectively assessed performance of experienced practitioners.
The aim of this study is to report the main performance outcomes of the T-REC trial. The investigators will compare differences between four groups in performance level as assessed by binary performance metrics of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.
The four groups deffers for the training methodology used (PBP vs traditional training). The dependant variables will be the i) time required to complete the procedure, ii) the number of procedure steps completed, iii) the number of errors made, iv) the number of critical errors made and whether the procedure was completed or not.
Measured: 1 year
Secondary outcomes (3)
Trainee's satisfaction as assessed by questionnaire. Does it influence outcome of surgical training? Comparison between PBP training versus traditional training group.
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 T-REC trial, 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 T-REC 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.
During the T-REC trial, all participants will be required to complete an online assessment. This will done on an online learning platform. A proficiency benchmark will be defined based on the mean score of experts on the same assessment. The PBP group will be required to pass this assessment in order to move forward to the clinical training in the lab. The Control group will be required to complete the exact same online assessment before and after their training and after performing the final task. The investigators aim to do a comparison between proficiency based progression training versus traditional training for a emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system task in the regard of the e-learning scores.
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 posted27 Nov 2023
- Study start10 Aug 2023
- Primary completion3 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orsi Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Collà Ruvolo, MD, Principal investigator, Orsi Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147128
- Sponsor's protocol ID
- T-REC
- Acronym
- T-REC
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 29 Nov 2023
- 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 30327396Cates CU, Lonn L, Gallagher AG. Prospective, randomised and blinded comparison of proficiency-based progression full-physics virtual reality simulator training versus invasive vascular experience for learning carotid artery angiography by very experienced operators. BMJ Simul Technol Enhanc Learn. 2016 Feb 8;2(1):1-5. doi: 10.1136/bmjstel-2015-000090. eCollection 2016.
PubMed 35516451Angelo 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 12368674de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622.
PubMed 18519629Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by surgeons at three teaching hospitals. Surgery. 2003 Jun;133(6):614-21. doi: 10.1067/msy.2003.169.
PubMed 12796727Greenberg CC, Regenbogen SE, Studdert DM, Lipsitz SR, Rogers SO, Zinner MJ, Gawande AA. Patterns of communication breakdowns resulting in injury to surgical patients. J Am Coll Surg. 2007 Apr;204(4):533-40. doi: 10.1016/j.jamcollsurg.2007.01.010.
PubMed 17382211Collins JW, Dell'Oglio P, Hung AJ, Brook NR. The Importance of Technical and Non-technical Skills in Robotic Surgery Training. Eur Urol Focus. 2018 Sep;4(5):674-676. doi: 10.1016/j.euf.2018.08.018. Epub 2018 Sep 11.
PubMed 30217631
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proficiency Based Progression Training Versus Traditional Training During a Robotic Emergency Conversion Due to a Vessel Injury in a Simulated Setting: a Prospective, Randomized, Multicenter Clinical Trial: The T-REC Trial
- ClinicalTrials.gov ID
- NCT06147128
- Acronym / sponsor ID
- T-REC / T-REC
- Conditions
- Educational Problems
- Keywords
- Training, Robotic surgery, Proficiency based progression, Emergency undocking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Orsi AcademyUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 3 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Nov 2023 (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 traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.
Detailed description
In a prospective, randomized and blinded study surgical residents (n = 48) from Belgium university (i.e. the Katholieke Universiteit [KU] Leuven and University of Gent residency training programs) will be enrolled and randomized to Traditional type training proficiency-based progression (PBP) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. Specifically, this study will include four independent arms, each employing different training methodologies for technical skills (TS) and non-technical skills (NTS).
Group 1 will receive standard training for both TS and NTS. Group 2 will receive PBP training for TS and standard training for NTS. Group 3 will receive standard training for TS and PBP training for NTS. Group 4 will receive PBP training for both TS and NTS.
All four group will receive the same e-learning on TS and NTS (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, TS and NTS). The Traditional trained group will train in the same 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.
Investigators will be trained in pairs to assess 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 TS and NTS for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Traditional Trained | – | Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab modelTrainees in the Traditional trained group will have an e-learning didactic component (specifically on the steps 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 the trainees will complete a summative assessment of their knowledge. The trainees will then be shown how and then trained to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery task. The scenario will be demonstrated initially by an expert and who will then proctor the trainees in the same technique. |
| Experimental: PBP for Technical emergency undocking skills | – | Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab 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 on TS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical skills. |
| Experimental: PBP for Non-Technical emergency undocking skills | – | Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab 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 on NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of non-technical skills. |
| Experimental: PBP for Technical and Non-Technical emergency undocking skills | – | Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab 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 on both TS and NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical and non-technical skills. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in urology, surgery and gynecology from Belgium universities (i.e. the KU Leuven and University of Gent residency training programs) from the first to the last year.
Key inclusion criteria (2 listed)
- recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery.
- Ability to perform a laparotomy
Key exclusion criteria (1 listed)
- Any robotic experience with emergency undocking.
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 |
|---|---|---|
| Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab modelAlso: Robotic emergency conversionPerformance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system | Procedure or surgery | Active Comparator: Traditional Trained, Experimental: PBP for Non-Technical emergency undocking skills, Experimental: PBP for Technical and Non-Technical emergency undocking skills, Experimental: PBP for Technical emergency undocking skills |
Primary outcome
Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.
Time frame: 1 year
Proficiency level will be determined by objectively assessed, validated, binary performance operative metrics where the proficiency benchmark is defined on the mean of the objectively assessed performance of experienced practitioners. The aim of this study is to report the main performance outcomes of the T-REC trial. The investigators will compare differences between four groups in performance level as assessed by binary performance metrics of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system. The four groups deffers for the training methodology used (PBP vs traditional training). The dependant variables will be the i) time required to complete the procedure, ii) the number of procedure steps completed, iii) the number of errors made, iv) the number of critical errors made and whether the procedure was completed or not.
3 secondary outcomes
Trainee's satisfaction as assessed by questionnaire. Does it influence outcome of surgical training? Comparison between PBP training versus traditional training group.
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.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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 35516451Cates CU, Lonn L, Gallagher AG. Prospective, randomised and blinded comparison of proficiency-based progression full-physics virtual reality simulator training versus invasive vascular experience for learning carotid artery angiography by very experienced operators. BMJ Simul Technol Enhanc Learn. 2016 Feb 8;2(1):1-5. doi: 10.1136/bmjstel-2015-000090. eCollection 2016.
- 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 18519629de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622.
- Gallagher Anthony, O'Sullivan Gerarld. Fundamentals of Surgical Simulation \[Internet\]. London: Springer London; 2012Link provided by the sponsor.
- 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.
Claudia Collà Ruvolo, 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?
An observational study of Educational Problems, run by Orsi Academy 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 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
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?
Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system. (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 NCT06147128, which also lists 16 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 29 Nov 2023.