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Home- vs. Hospital-based Surgical Training

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06301230
Enrollment
24
Registered
2024-03-08
Start date
2020-09-01
Completion date
2021-12-31
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Training

Keywords

Surgical training, Surgical skill performance, PLET, Portable Laparoscopic Trainer

Brief 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.

Interventions

DEVICEPortable 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.

Sponsors

University of Basel
CollaboratorOTHER
Clarunis - Universitäres Bauchzentrum Basel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* ≥ 18 years * surgical resident

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Exercise timeBaseline, 6 weeks, 12 weeksAmount of time surgical residents need for laparoscopic exercises
Assessment ratingBaseline, 6 weeks, 12 weeksSubjective and objective assessment ratings of surgical skills during exercise

Secondary

MeasureTime frameDescription
Qualitative feedback12 weeksOpen questions about motivation of participating in the study and improving surgical skills

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026