NCT04401306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

February 12, 2021

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

May 13, 2020

Last Update Submit

February 11, 2021

Conditions

Educational ProblemsSurgery

Keywords

EducationSimulationSurgeryTransferSelf-regulated learningGynecologyUrologyLaparoscopyHome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Test-score SUTT

    1-7 months

  • Training time

    6-8 weeks

  • Training distribution

    6-8 weeks

  • Pass-rates

    6-8 weeks

Other Outcomes (1)

  • Interview

    0-3 months

Study Arms (2)

Self-regulated simulation training

EXPERIMENTAL
Other: Home-based self-regulated simulation training (SRST)

Instructor-regulated simulation training

ACTIVE COMPARATOR
Other: Centralized instructor-regulated simulation training (IRST)

Interventions

Home-based self-regulated simulation training (SRST)OTHER

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.

Self-regulated simulation training
Centralized instructor-regulated simulation training (IRST)OTHER

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.

Instructor-regulated simulation training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Sciences Education, Aarhus University

Aarhus, Danmark, 8200, Denmark

Location

Study Officials

  • Sigurd B Sloth, MD, PhD fellow

    Centre for Health Sciences Education, Aarhus University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 26, 2020

Study Start

March 1, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

February 12, 2021

Record last verified: 2020-05

Locations

DK(1)