Home- vs. Hospital-based Surgical Training

NCT06301230 | Completed

• 1 other identifier: PLET-2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Training

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Exercise time

  Amount of time surgical residents need for laparoscopic exercises

  Baseline, 6 weeks, 12 weeks

• Assessment rating

  Subjective and objective assessment ratings of surgical skills during exercise

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (1)

• Qualitative feedback

  12 weeks

Study Arms (2)

Hospital-based surgical training group

ACTIVE COMPARATOR

This group represents the surgical residents who trained with PLET at the hospital.

Device: Portable Laparoscopic Trainer (PLET)

Home-based surgical training group

EXPERIMENTAL

This group represents the surgical residents who trained with PLET at home.

Device: Portable Laparoscopic Trainer (PLET)

Interventions

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.

Home-based surgical training group; Hospital-based surgical training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• surgical resident

You may not qualify if:

• none

Sponsors & Collaborators

• Clarunis - Universitäres Bauchzentrum Basel: lead
• University of Basel: collaborator

Study Sites (1)

Clarunis Universitäres Bauchzentrum Basel

Basel, 4002, Switzerland

Location

Related Publications (1)

• Kuemmerli C, Linke K, Daume D, Germann N, Peterli R, Muller-Stich B, Klasen JM. The PLET (Portable Laparoscopic Endo-Trainer) study: a randomized controlled trial of home- versus hospital-based surgical training. Langenbecks Arch Surg. 2024 Jun 13;409(1):186. doi: 10.1007/s00423-024-03375-z.

  PMID: 38869683 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 8, 2024
• Study Start: September 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

CH (1)