Remote Training in Laparoscopy

Study Overview
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Brief Summary
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The study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study population is first-year trainees in the specialties General Surgery, Urology and Obstetrics and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year trainees will be randomized into two groups, one receiving SRST and one receiving IRST in basic laparoscopic skills.

Official Title
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Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.

Conditions
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Educational Problems, Surgery

Intervention / Treatment
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* Other: Home-based self-regulated simulation training (SRST)
* Other: Centralized instructor-regulated simulation training (IRST)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is a medical doctor Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and obstetrics. Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: Performed > 50 lap procedures prior to enrollment participated in training programs provided by the former course provider in the postgraduate training region of northern Denmark
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-regulated simulation training<br> | Other: Home-based self-regulated simulation training (SRST)<br>* Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.<br>|
| Active Comparator: Instructor-regulated simulation training<br> | Other: Centralized instructor-regulated simulation training (IRST)<br>* Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time for laparoscopic skills test (LASTT). | Laparoscopic skills testing models (pre-test, post-test and retention-test). Scoring based on mean timing of 3 consecutively performed exercises (0-180 secs). Low time-scores are better than high time scores. | 0-7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-score SUTT | Laparoscopic knot tying testing model (post-test and retention test). Blinded outcome assessor. Score based on timing and quality of sutures and stitches (score range -2 to 18). High score is better than low score. | 1-7 months | 
| Training time | Accumulated raw training time (mins) | 6-8 weeks | 
| Training distribution | Number of training sessions | 6-8 weeks | 
| Pass-rates | Pass/failure of proficiency-based training program (binary) | 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Simulation, Surgery, Transfer, Self-regulated learning, Gynecology, Urology, Laparoscopy, Home