Remote Training in Laparoscopy

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT04401306
Collaborator
Central Denmark Region (Other), Northern Denmark Region (Other), KARL STORZ Endoscopy Denmark (Other)
46
1
2
18
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Home-based self-regulated simulation training (SRST)
  • Other: Centralized instructor-regulated simulation training (IRST)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Training time [6-8 weeks]

    Accumulated raw training time (mins)

  3. Training distribution [6-8 weeks]

    Number of training sessions

  4. Pass-rates [6-8 weeks]

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

Other Outcome Measures

  1. Interview [0-3 months]

    Qualitative data: Semi-structured interviews

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Health Sciences Education, Aarhus University Aarhus Danmark Denmark 8200

Sponsors and Collaborators

  • University of Aarhus
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04401306
Other Study ID Numbers:
  • sbs_au235143
First Posted:
May 26, 2020
Last Update Posted:
Feb 12, 2021
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus

Study Results

No Results Posted as of Feb 12, 2021