Home- vs. Hospital-based Surgical Training

Surgical Training Clinical Trial

Official title:

The PLET Study: A Randomized Controlled Trial of Home- Versus Hospital-based Surgical Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301230
• Other study ID #: PLET-2022
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2024
• Source: Clarunis - Universitäres Bauchzentrum Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years

• surgical resident

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Surgical Training

Intervention

Device:
• Portable Laparoscopic Trainer (PLET)
The PLET trainer is light and easy to transport packed in a bag and consists of a foldable plastic box, which can be assembled in less than 30 seconds by means of simple handles. There are three accesses for the surgical instruments (ports) as well as a central recess over which a tablet with an integrated camera can be placed. Each participant received a previously prepared opaque envelope containing a black or white USB stick from the Principal Investigator with the assignments on it as part of the randomization process. The outcome assessors were blinded to the allocation.

Locations

Country	Name	City	State
Switzerland	Clarunis Universitäres Bauchzentrum Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Clarunis - Universitäres Bauchzentrum Basel	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise time	Amount of time surgical residents need for laparoscopic exercises	Baseline, 6 weeks, 12 weeks
Primary	Assessment rating	Subjective and objective assessment ratings of surgical skills during exercise	Baseline, 6 weeks, 12 weeks
Secondary	Qualitative feedback	Open questions about motivation of participating in the study and improving surgical skills	12 weeks