Skip to main content
OpenTrials
Completed

NCT Number: NCT04401306

Remote Training in Laparoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Educational Problems Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Health Sciences Education, Aarhus University

Aarhus, Danmark, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean time for laparoscopic skills test (LASTT).

    Time frame: 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 outcomes

  1. Test-score SUTT

    Time frame: 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.

  2. Training time

    Time frame: 6-8 weeks

    Accumulated raw training time (mins)

  3. Training distribution

    Time frame: 6-8 weeks

    Number of training sessions

  4. Pass-rates

    Time frame: 6-8 weeks

    Pass/failure of proficiency-based training program (binary)

Other outcomes

  1. Interview

    Time frame: 0-3 months

    Qualitative data: Semi-structured interviews

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region
  • KARL STORZ Endoscopy Denmark
  • North Denmark Region

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 26, 2020
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.