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Clinical Trials/NCT06301230
NCT06301230
Completed
Not Applicable

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

Clarunis - Universitäres Bauchzentrum Basel1 site in 1 country24 target enrollmentStarted: September 1, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Clarunis - Universitäres Bauchzentrum Basel
Enrollment
24
Locations
1
Primary Endpoint
Assessment rating

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • ≥ 18 years
  • surgical resident

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Assessment rating

Time Frame: Baseline, 6 weeks, 12 weeks

Subjective and objective assessment ratings of surgical skills during exercise

Exercise time

Time Frame: Baseline, 6 weeks, 12 weeks

Amount of time surgical residents need for laparoscopic exercises

Secondary Outcomes

  • Qualitative feedback(12 weeks)

Investigators

Sponsor
Clarunis - Universitäres Bauchzentrum Basel
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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