Haptic Devices Impact on Laparoscopic Simulators
Sponsor
Copenhagen Academy for Medical Education and Simulation (Other)
Overall Status
Completed
CT.gov ID
NCT05191589
Collaborator
(none)
40
2
2
4
20
4.9
Study Details
Study Description
Brief Summary
The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Haptic Devices vs Non Haptic Devices - Results of a Randomized Trial
Actual Study Start Date
:
Oct 1, 2020
Actual Primary Completion Date
:
Jan 15, 2021
Actual Study Completion Date
:
Feb 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group In the intervention group trainees will train in an already validated laparoscopic training program with haptic devices. |
Other: Haptic
Trainees are randomized in this group to use the haptic device.
|
| No Intervention: Control In the control group trainees will complete the same validated training program in the conventional non-haptic setting. |
Outcome Measures
Primary Outcome Measures
- Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure [From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)]
Measured in minutes
Secondary Outcome Measures
- Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure after 3-6 weeks without laparoscopic training on the non-haptic devices (retention test). [From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)]
Measured in minutes
Other Outcome Measures
- Exploratory outcome: To observe and register mechanical/technical malfunctions during the intervention and retention. [During trial, up to 1 year]
All mechanical malfunction will be registered and classified afterwards
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Must be a junior doctor working in a surgical department
Exclusion Criteria:
-
Having performed any laparoscopic surgeries as primary surgeon
-
Lack of Basic Danish on a conversational basis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CAMES | Copenhagen | Region Hovedstaden | Denmark | 2100 |
| 2 | CAMES | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Copenhagen Academy for Medical Education and Simulation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anishan Vamadevan,
Medical Student and Research Fellow,
Copenhagen Academy for Medical Education and Simulation
ClinicalTrials.gov Identifier:
NCT05191589
Other Study ID Numbers:
- CAMES
First Posted:
Jan 13, 2022
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No