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Completed

NCT Number: NCT06301230

Home- vs. Hospital-based Surgical Training

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.

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Key information

Conditions

Surgical Training

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clarunis Universitäres Bauchzentrum Basel

Basel, 4002, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • surgical resident

Exclusion criteria

  • none

Treatment and study plan

Portable Laparoscopic Trainer (PLET)

Device

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.

Primary outcomes

  1. Exercise time

    Time frame: Baseline, 6 weeks, 12 weeks

    Amount of time surgical residents need for laparoscopic exercises

  2. Assessment rating

    Time frame: Baseline, 6 weeks, 12 weeks

    Subjective and objective assessment ratings of surgical skills during exercise

Secondary outcomes

  1. Qualitative feedback

    Time frame: 12 weeks

    Open questions about motivation of participating in the study and improving surgical skills

Sponsors and collaborators

Lead sponsor

Clarunis - Universitäres Bauchzentrum Basel

Other

Collaborators

  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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