NCT04541615

Brief Summary

The training of robotic surgical procedural skills has been challenged by changes in work practices and safety concerns specifically related to training. In surgery and procedural medicine simulation-based training has been demonstrated to supplant the early part of the learning curve. Training in the skills laboratory is however expensive because of equipment and supervision burdens. In this study the investigators will assess the economic impact of proficiency-based progression (PBP) e-learning training prior to training in the skills laboratory. 48 trainees will be randomly assigned to one of four groups. 1) will receive an apprenticeship type training (Group 1 ; n=12), 2) A standard or traditional trained group (Group 2; n=12) will then receive face-to-face lectures on how to perform the robotic surgical training task (i.e., ORSI chicken anastomosis task for learning robotic suturing and knot tying.) 3) The third group (Group 3; n=12) will have e-learning training prior to training in the skills laboratory and then learn the same task. 4) The fourth group (Group 4; n=12) will have the exact same pre-course e-learning curriculum as Group 3 but will be required to study it until they score at the quantitatively defined proficiency benchmark of experienced robotic surgeons, i.e., the mean performance level of experienced robotic surgeons - they can complete the task with \<10 performance errors. The research will be conducted at the laboratory skills lab of Orsi Academy, Proefhoevestraat 12 9090 Melle. It will be conducted by Maxime Lasseel and Laura Langhendries, under direct guidance of Dr. S. Puliatti, Prof. A.G. Gallagher and Prof. A. Mottrie.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

26 days

First QC Date

August 26, 2020

Last Update Submit

December 18, 2020

Conditions

SurgeryE-learning

Keywords

E-learningSurgeryProficiency-based training

Outcome Measures

Primary Outcomes (3)

  • Errors made during the task at baseline

    We will measure the amount of errors made bij trainees during the procedure via a metric based system at baseline when the participants do their first chicken anastomosis task. This task takes maximum 30 minutes

    30 minutes

  • Errors made during the task at proficiency

    Participants repeat the chicken anastomosis task in order to train themselves. Every 30 minutes, a new participant starts the task. Examinators will assess the errors made by trainees via a metric based system at every attempt until they demonstrate proficiency. Every 30 minutes, errors will be assessed.

    30 minutes

  • Cost of training (in euro)

    The economic impact of proficiency-based training. We will watch and note the resources utilised (amount of sutures, amount of chickens utilised by the participants) and time needed (in minutes) to reach proficiency. By knowing these elements, we can calculate the price per hour that it costs to train trainees in the specific groups.

    Up to 9 days

Study Arms (4)

Group 1: Online didactic to proficiency PBP+

ACTIVE COMPARATOR

Group 1 Pre-trained group will receive information on how to optimally perform the ORSI chicken anastomosis task and the material will be delivered online via the ORSI e-learning platform. They will be given access to the material two weeks before their training. Unlike the other groups, Group 1 will be required to study the material to a pre-defined performance benchmark or proficiency level. Once the online course is completed, participants have to perform the orsi chicken anastomosis task.

Procedure: Online course with proficiency test

Group 2: Online didactic PBP+

ACTIVE COMPARATOR

The Pre-trained group (Group 2) will receive the exact same information as Group 1 on how to optimally perform the ORSI chicken anastomosis task but they are not required to study the material to a pre-defined proficiency benchmark. The time they spend on the task and effort expended will be logged. Once the online course is completed, participants have to perform the orsi chicken anastomosis task.

Procedure: Online course

Group 3: Standard training group

ACTIVE COMPARATOR

The standard trained group will receive face-to-face lectures on how to perform the ORSI chicken anastomosis task. It will not differ from what they would normally receive during a traditional surgery training course when they arrive at the ORSI academy for their training. The content of the face-to face lecture is the same as in the e-learning courses. After the face-to face lecture, the participants have to perform the orsi chicken anastomosis task.

Procedure: Standard training group

Group 4: Apprenticeship Group

ACTIVE COMPARATOR

The apprenticeship trained group will not receive face-to-face lectures or e-learning on how to perform the ORSI chicken anastomosis task. They will however receive hands-on practical one-to-one training during a traditional surgical training course, with deliberate practice. During this course, clinicians will train the participants on how to perform the orsi anastomosis task. They will also receive published materials describing how best to perform the task and mentoring on suturing and knot tying by a task expert who will guide their performance.

Procedure: Apprenticeship group

Interventions

Online course with proficiency testPROCEDURE

Participants will receive an online e-course with a proficiency test at the end. Afterwards, participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end.

Also known as: Online didactic to proficiency PBP++
Group 1: Online didactic to proficiency PBP+
Online coursePROCEDURE

Participants will receive an online e-course but are not required to pass the proficiency test. Afterwards, participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end.

Also known as: Online didactic PBP +
Group 2: Online didactic PBP+
Standard training groupPROCEDURE

After receiving a traditional lecture, participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end.

Group 3: Standard training group
Apprenticeship groupPROCEDURE

Participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end. Participants will only receive papers on how the task will be performed and clinicians will help them with completion of the task.

Group 4: Apprenticeship Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Second bachelor - second master students enrolled in a University.

You may not qualify if:

  • Previous experience on robotic surgery tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orsi Academy

Melle, Oost-Vlaanderen, 9090, Belgium

Location

Related Publications (2)

  • Puliatti S, Rodriguez Penaranda N, Amato M, De Groote R, Farinha R, Bunting B, van Cleynenbreugel B, Mottrie A, Gallagher AG. Randomised trial on the economic impact of proficiency-based progression vs conventional robotic surgical training. BJU Int. 2026 Jan 2. doi: 10.1111/bju.70130. Online ahead of print.

    PMID: 41482504DERIVED

  • Puliatti S, Amato M, Farinha R, Paludo A, Rosiello G, De Groote R, Mari A, Bianchi L, Piazza P, Van Cleynenbreugel B, Mazzone E, Migliorini F, Forte S, Rocco B, Kiely P, Mottrie A, Gallagher AG. Does quality assured eLearning provide adequate preparation for robotic surgical skills; a prospective, randomized and multi-center study. Int J Comput Assist Radiol Surg. 2022 Mar;17(3):457-465. doi: 10.1007/s11548-021-02545-4. Epub 2022 Jan 7.

    PMID: 34997525DERIVED

Study Officials

  • Stefano Puliatti, Medical Dir

    ORSI Acadmy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know in which group they will be assigned and they will not know the study design. The investigators know which study group is training in the skills lab.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 48 subjects will be randomized in 4 different groups of 12 subjects each. The first group will receive information on how to optimally perform the anastomosis task and the material will be delivered via an e-learning platform. Group 1 will be required to study the material to a pre-defined proficiency level. The second group will receive the exact same information as Group 1 on how to optimally perform the anastomosis task but they are not required to study the material to a pre-defined proficiency benchmark. The third group will receivelectures on how to perform the chicken anastomosis task. It will not differ from what they would normally receive during a traditional surgery training course when they arrive at the ORSI Academy for their training. The fourth group will not receive lectures or e-learning on how to perform the anastomosis task. They will however receive practical one-to-one training during a traditional surgical training course, with deliberate practice.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 9, 2020

Study Start

August 25, 2020

Primary Completion

September 20, 2020

Study Completion

September 20, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)