NCT06301230

Home- vs. Hospital-based Surgical Training

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Clarunis - Universitäres Bauchzentrum Basel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Training

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: Switzerland