Remote Training in Laparoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Educational Problems
• Intervention / Treatment: Other: Home-based self-regulated simulation training (SRST); Other: Centralized instructor-regulated simulation training (IRST)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Aarhus, Danmark, Denmark, 8200
      • Centre for Health Sciences Education, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-regulated simulation training	Other: Home-based self-regulated simulation training (SRST); 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.
Active Comparator: Instructor-regulated simulation training	Other: Centralized instructor-regulated simulation training (IRST); 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interview	Qualitative data: Semi-structured interviews	0-3 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Central Denmark Region; Northern Denmark Region; KARL STORZ Endoscopy Denmark
• Investigators: Principal Investigator: Sigurd B Sloth, MD, PhD fellow, Centre for Health Sciences Education, Aarhus University, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Transfer; Education; Gynecology; Laparoscopy; Simulation; Urology; Self-regulated learning; Home
• Other Study ID Numbers: sbs_au235143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No