Performance of Wrong Procedure (Operation)NCT02486575
Trial on Laparoscopic Simulation Based on Mentoring
A study testing Self-learning and Mentoring in people with Performance of Wrong Procedure (Operation), run by Università degli Studi di Brescia.
Trial summary
More than 50 residents in surgical specialities (OB\&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator experience. Read more about this study
- Who is it for?
- Ages 24 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance of Wrong Procedure (Operation)
- What is being tested?
- Self-learning and Mentoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2014
- 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 24 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residents in surgical specialities at University of Brescia
Who cannot join
- Residents not available for the training (outside the Country, not interested, etc.)
About this study
Official title: Comparison of Laparoscopic Simulation Training Between Mentoring and Self-learning Technique
More than 50 residents in surgical specialities (OB\&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator experience. The first one will train to FLS (fundamentals of laparoscopic surgery) following pre-recorded instruction from course materials; the second one will be mentored by a proctor in single training section. The aim is to evaluate the best way to train residents applying for the very first time in an extensive way the "fundamentals of laparoscopic surgery" program in an Italian Institution.
Read the detailed description
A complete 5-skills based FLS (fundamentals of laparoscopic surgery) curriculum is proposed to each resident enrolled in the trial. The first group trains with videos and written instructions, without any kind of support from a tutor. The second group is aided by a tutor, receiving tailored teaching and mentoring.
The primary goal was to asses the impact of tutoring in Passing the FLS examination at the end of a 3-months training: the outcome is the dichotomous PASS/DON'T PASS THE EXAM. At the same time the investigators assess the performance to record and evaluate any differences in groups and subgroups (year of residency, gender, specialty, etc.).
The evaluation was based on FLS program standards, recording time and penalties.
The training and evaluation setting was created to exactly reproduce the FLS one, mostly using the FLS material itself, or using FLS admitted/compatible instrumentation.
- Being tested
- Self-learning, Mentoring
- Keywords
- Residents, Training, simulation, mentoring, proctor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-learningOther
Every resident will train following the video instruction included in the FLS course material and related written instruction only
MentoringOther
A tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions.
| Study group | Role | What they receive |
|---|---|---|
| self-learning | Other | Residents training alone with pre-recorded instructions. No tutor intervention, only self-learning training Intervention Type: Behavioral (video-based and instruction based learning) Receives: Other: Self-learning |
| Mentoring | Other | Residents training with a mentor, giving tailored instruction to each of them and correction to wrong behaviours.
Intervention Type: Behavioral (tutored learning) Receives: Other: Mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES
2 months for the training and final evaluation in 2 weeks. Parameters evaluated during the final test are as defined by SAGES at "http://www.flsprogram.org" in the "manual skills" module.
Measured: 2 months to compleete the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
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 Performance of Wrong Procedure (Operation)Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Gheza, Università degli Studi di Brescia
- Investigators
- Nazario Portolani, MD, Study director, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486575
- Sponsor's protocol ID
- TUTOR LAP SYM
- Status last verified
- Jun 2015
- First submitted
- 24 Jan 2014
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gheza F, Raimondi P, Solaini L, Coccolini F, Baiocchi GL, Portolani N, Tiberio GAM. Impact of one-to-one tutoring on fundamentals of laparoscopic surgery (FLS) passing rate in a single center experience outside the United States: a randomized controlled trial. Surg Endosc. 2018 Nov;32(11):4428-4435. doi: 10.1007/s00464-018-6185-1. Epub 2018 Apr 11.
PubMed 29644465
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Simulation Training Between Mentoring and Self-learning Technique
- ClinicalTrials.gov ID
- NCT02486575
- Acronym / sponsor ID
- TUTOR LAP SYM
- Keywords
- Residents, Training, simulation, mentoring, proctor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
More than 50 residents in surgical specialities (OB\&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator experience. The first one will train to FLS (fundamentals of laparoscopic surgery) following pre-recorded instruction from course materials; the second one will be mentored by a proctor in single training section. The aim is to evaluate the best way to train residents applying for the very first time in an extensive way the "fundamentals of laparoscopic surgery" program in an Italian Institution.
Detailed description
A complete 5-skills based FLS (fundamentals of laparoscopic surgery) curriculum is proposed to each resident enrolled in the trial. The first group trains with videos and written instructions, without any kind of support from a tutor. The second group is aided by a tutor, receiving tailored teaching and mentoring.
The primary goal was to asses the impact of tutoring in Passing the FLS examination at the end of a 3-months training: the outcome is the dichotomous PASS/DON'T PASS THE EXAM. At the same time the investigators assess the performance to record and evaluate any differences in groups and subgroups (year of residency, gender, specialty, etc.).
The evaluation was based on FLS program standards, recording time and penalties.
The training and evaluation setting was created to exactly reproduce the FLS one, mostly using the FLS material itself, or using FLS admitted/compatible instrumentation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-learning | Other | Other: Self-learningResidents training alone with pre-recorded instructions. No tutor intervention, only self-learning training Intervention Type: Behavioral (video-based and instruction based learning) |
| Mentoring | Other | Other: MentoringResidents training with a mentor, giving tailored instruction to each of them and correction to wrong behaviours. Intervention Type: Behavioral (tutored learning) |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residents in surgical specialities at University of Brescia
Key exclusion criteria (1 listed)
- Residents not available for the training (outside the Country, not interested, etc.)
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 |
|---|---|---|
| Self-learningEvery resident will train following the video instruction included in the FLS course material and related written instruction only | Other | self-learning |
| MentoringA tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions. | Other | Mentoring |
Primary outcome
Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES
Time frame: 2 months to compleete the training
2 months for the training and final evaluation in 2 weeks. Parameters evaluated during the final test are as defined by SAGES at "http://www.flsprogram.org" in the "manual skills" module.
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 1 Jul 2015.
- Derived from this study: PubMed 29644465Gheza F, Raimondi P, Solaini L, Coccolini F, Baiocchi GL, Portolani N, Tiberio GAM. Impact of one-to-one tutoring on fundamentals of laparoscopic surgery (FLS) passing rate in a single center experience outside the United States: a randomized controlled trial. Surg Endosc. 2018 Nov;32(11):4428-4435. doi: 10.1007/s00464-018-6185-1. Epub 2018 Apr 11.
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.
Nazario Portolani, MD study director
Università degli Studi di Brescia
Questions about this trial
What is this clinical trial studying?
A study testing Self-learning and Mentoring in people with Performance of Wrong Procedure (Operation), run by Università degli Studi di Brescia.
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 1 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 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES (time frame: 2 months to compleete the training). 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 NCT02486575, 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 1 Jul 2015.