Remote Training in Laparoscopy

Not Applicable

Completed

• Conditions: Educational Problems; Surgery
• Interventions: Other: Home-based self-regulated simulation training (SRST); Other: Centralized instructor-regulated simulation training (IRST)

• Registration Number: NCT04401306
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-26
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-regulated simulation training	Home-based self-regulated simulation training (SRST)	-
Instructor-regulated simulation training	Centralized instructor-regulated simulation training (IRST)	-

Primary Outcome Measures

Name	Time	Method
Mean time for laparoscopic skills test (LASTT).	0-7 months	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.

Secondary Outcome Measures

Name	Time	Method
Training time	6-8 weeks	Accumulated raw training time (mins)
Pass-rates	6-8 weeks	Pass/failure of proficiency-based training program (binary)
Test-score SUTT	1-7 months	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.
Training distribution	6-8 weeks	Number of training sessions

Trial Locations

Locations (1)

Centre for Health Sciences Education, Aarhus University; 🇩🇰 Aarhus, Danmark, Denmark