Remote Training in Laparoscopy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401306
• Other study ID #: sbs_au235143
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Educational Problems
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Centre for Health Sciences Education, Aarhus University	Aarhus	Danmark

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region, KARL STORZ Endoscopy Denmark, Northern Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interview	Qualitative data: Semi-structured interviews	0-3 months
Primary	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	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
Secondary	Training time	Accumulated raw training time (mins)	6-8 weeks
Secondary	Training distribution	Number of training sessions	6-8 weeks
Secondary	Pass-rates	Pass/failure of proficiency-based training program (binary)	6-8 weeks