Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06255080
Other study ID # Software changes on LAPSIM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date January 20, 2023

Study information

Verified date February 2024
Source Copenhagen Academy for Medical Education and Simulation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Simulation based training is a standard part of surgical training. Over the years virtual reality simulator have been more and more integrated into the surgical curriculum for surgical novices. Evidence shows that practicing using proficiency-based training programs significantly reduces the operation time and complication rates for during intial operations for young doctors. The aim of this trial is to examine if skills obtained on a newer software version is transferable to the original software.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 20, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Medical students without any prior laparoscopy experience in both a clinical or simulated setting Exclusion Criteria: - Prior experience with simulation based laparoscopy or clinical experience with laparoscopy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Training intervention
The intervention consists of making the intervention group practice till proficiency using the 2019-version. The control group practices till they have reached proficiency using the standard 2016-version. We wanted to compare time to completetion for the intervention. For the follow-up test we invited all participants to return after 4-6 weeks (where no training was allowed) and made them practice till proficiency again using the standard 2016-version. Time to reach proficiency for the follow-up test was compared.

Locations

Country Name City State
Denmark Copenhagen Academy for Medical Education and Simulation Copenhagen Capital Region

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen Academy for Medical Education and Simulation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to reach proficiency (in minutes) To examine if there was any difference in the time to reach proficiency for the two software versions 1-2 months
Secondary Transferability of skills We made all 20 participants return for a follow-up test, where they had to practice till they reached proficiency again using the standard 2016-version. Time to complete was compared 2-3 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04515485 - A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
Completed NCT01725477 - Laparoscopic Tubal Patency Assessment N/A
Recruiting NCT01093079 - Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes N/A
Recruiting NCT01093430 - Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy? N/A
Completed NCT01092013 - Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices N/A
Completed NCT00535990 - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Recruiting NCT06044909 - Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Not yet recruiting NCT05389241 - Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Recruiting NCT02827292 - Effect of Music on Inflammatory Response During Laparoscopic Surgery N/A
Not yet recruiting NCT06092684 - The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery Phase 3
Terminated NCT01008709 - Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery N/A
Active, not recruiting NCT05363813 - Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery N/A
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT05031182 - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique. N/A
Active, not recruiting NCT05302622 - Detecting the Most Efficient Residency Time for Laparoscopic Simulators N/A
Recruiting NCT03684291 - Hemodynamic Effects of Ventilation Modes
Recruiting NCT06117748 - Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery N/A
Recruiting NCT03739944 - Different Surgical Approaches in Patients of Early-stage Cervical Cancer Phase 3
Completed NCT02079337 - Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery Phase 4