Surgical TrainingNCT06301230
Home- vs. Hospital-based Surgical Training
A study testing Portable Laparoscopic Trainer (PLET) in people with Surgical Training, run by Clarunis - Universitäres Bauchzentrum Basel at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Training
- What is being tested?
- Portable Laparoscopic Trainer (PLET)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- surgical resident
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PLET Study: A Randomized Controlled Trial of Home- Versus 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.
- Conditions
- Surgical Training
- Being tested
- Portable Laparoscopic Trainer (PLET)
- Keywords
- Surgical training, Surgical skill performance, PLET, Portable Laparoscopic Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based surgical training group | Active comparator | This group represents the surgical residents who trained with PLET at the hospital. Receives: Device: Portable Laparoscopic Trainer (PLET) |
| Home-based surgical training group | Experimental | This group represents the surgical residents who trained with PLET at home. Receives: Device: Portable Laparoscopic Trainer (PLET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise time
Amount of time surgical residents need for laparoscopic exercises
Measured: Baseline, 6 weeks, 12 weeks
Assessment rating
Subjective and objective assessment ratings of surgical skills during exercise
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (1)
Qualitative feedback
Open questions about motivation of participating in the study and improving surgical skills
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarunis - Universitäres Bauchzentrum Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301230
- Sponsor's protocol ID
- PLET-2022
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38869683
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PLET Study: A Randomized Controlled Trial of Home- Versus Hospital-based Surgical Training
- ClinicalTrials.gov ID
- NCT06301230
- Acronym / sponsor ID
- PLET-2022
- Conditions
- Surgical Training
- Keywords
- Surgical training, Surgical skill performance, PLET, Portable Laparoscopic Trainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Clarunis - Universitäres Bauchzentrum BaselUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-based surgical training group | Active comparator | Device: Portable Laparoscopic Trainer (PLET)This group represents the surgical residents who trained with PLET at the hospital. |
| Home-based surgical training group | Experimental | Device: Portable Laparoscopic Trainer (PLET)This group represents the surgical residents who trained with PLET at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years
- surgical resident
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Home-based surgical training group, Hospital-based surgical training group |
Primary outcome
Exercise time
Time frame: Baseline, 6 weeks, 12 weeks
Amount of time surgical residents need for laparoscopic exercises
Assessment rating
Time frame: Baseline, 6 weeks, 12 weeks
Subjective and objective assessment ratings of surgical skills during exercise
1 secondary outcome
Qualitative feedback
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 38869683Kuemmerli 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.
Related trials for Surgical Training
Not yet recruiting
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
Medical Education
Recruiting
Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Gynecologic Cancer Surgery
Prehabilitation, Preoperative Aerobic Training
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Recruiting
Blood Flow Restriction Training in Knee Arthropathy
Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Laparoscopic Trainer (PLET) in people with Surgical Training, run by Clarunis - Universitäres Bauchzentrum Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise time (time frame: Baseline, 6 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.