Educational ProblemsNCT04401306
Remote Training in Laparoscopy
A study testing Home-based self-regulated simulation training (SRST) and Centralized instructor-regulated simulation training (IRST) in people with Educational Problems and Surgery, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Educational Problems, Surgery
- What is being tested?
- Home-based self-regulated simulation training (SRST) and Centralized instructor-regulated simulation training (IRST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to 31 Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant is a medical doctor
- Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and obstetrics.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Performed > 50 lap procedures prior to enrollment
- participated in training programs provided by the former course provider in the postgraduate training region of northern Denmark
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre for Health Sciences Education, Aarhus University
Aarhus, Danmark, 8200
About this study
Official title: Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.
The study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study population is first-year trainees in the specialties General Surgery, Urology and Obstetrics and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year trainees will be randomized into two groups, one receiving SRST and one receiving IRST in basic laparoscopic skills.
- Conditions
- Educational Problems, Surgery
- Being tested
- Home-based self-regulated simulation training (SRST), Centralized instructor-regulated simulation training (IRST)
- Keywords
- Education, Simulation, Surgery, Transfer, Self-regulated learning, Gynecology, Urology, Laparoscopy, Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based self-regulated simulation training (SRST)Other
Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
Centralized instructor-regulated simulation training (IRST)Other
Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
| Study group | Role | What they receive |
|---|---|---|
| Self-regulated simulation training | Experimental | Not described Receives: Other: Home-based self-regulated simulation training (SRST) |
| Instructor-regulated simulation training | Active comparator | Not described Receives: Other: Centralized instructor-regulated simulation training (IRST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time for laparoscopic skills test (LASTT).
Laparoscopic skills testing models (pre-test, post-test and retention-test). Scoring based on mean timing of 3 consecutively performed exercises (0-180 secs). Low time-scores are better than high time scores.
Measured: 0-7 months
Secondary outcomes (4)
Test-score SUTT
Laparoscopic knot tying testing model (post-test and retention test). Blinded outcome assessor. Score based on timing and quality of sutures and stitches (score range -2 to 18). High score is better than low score.
Measured: 1-7 months
Training time
Accumulated raw training time (mins)
Measured: 6-8 weeks
Training distribution
Number of training sessions
Measured: 6-8 weeks
Pass-rates
Pass/failure of proficiency-based training program (binary)
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Mar 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, North Denmark Region, KARL STORZ Endoscopy Denmark
- Responsible party
- Sponsor
- Investigators
- Sigurd B Sloth, MD, PhD fellow, Principal investigator, Centre for Health Sciences Education, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401306
- Sponsor's protocol ID
- sbs_au235143
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.
- ClinicalTrials.gov ID
- NCT04401306
- Acronym / sponsor ID
- sbs_au235143
- Conditions
- Educational Problems, Surgery
- Keywords
- Education, Simulation, Surgery, Transfer, Self-regulated learning, Gynecology, Urology, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region, North Denmark Region, KARL STORZ Endoscopy Denmark
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 26 May 2020 (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 study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study population is first-year trainees in the specialties General Surgery, Urology and Obstetrics and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year trainees will be randomized into two groups, one receiving SRST and one receiving IRST in basic laparoscopic skills.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-regulated simulation training | Experimental | Other: Home-based self-regulated simulation training (SRST) |
| Instructor-regulated simulation training | Active comparator | Other: Centralized instructor-regulated simulation training (IRST) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is a medical doctor
- Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and obstetrics.
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (2 listed)
- Performed > 50 lap procedures prior to enrollment
- participated in training programs provided by the former course provider in the postgraduate training region of northern Denmark
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 |
|---|---|---|
| Home-based self-regulated simulation training (SRST)Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform. | Other | Self-regulated simulation training |
| Centralized instructor-regulated simulation training (IRST)Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform. | Other | Instructor-regulated simulation training |
Primary outcome
Mean time for laparoscopic skills test (LASTT).
Time frame: 0-7 months
Laparoscopic skills testing models (pre-test, post-test and retention-test). Scoring based on mean timing of 3 consecutively performed exercises (0-180 secs). Low time-scores are better than high time scores.
4 secondary outcomes
Test-score SUTT
Time frame: 1-7 months
Training time
Time frame: 6-8 weeks
Training distribution
Time frame: 6-8 weeks
Pass-rates
Time frame: 6-8 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 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Educational Problems
Not yet recruiting
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Educational Problems, Surgery
Active, not recruiting
Impact of Surgical Coaching on Resident ObGyn Laparoscopic Skills
Educational Problems
Not yet recruiting
Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes
Sleep Problems, Psychological
Active, not recruiting
Fostering Healthy Futures for Teens: An RCT
Child Abuse, Child Neglect
Recruiting
Health Equity and Rural Education (HERE!) Clinical Trial
Behavioral Symptoms, Community Health Workers
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.
Sigurd B Sloth, MD, PhD fellow principal investigator
Centre for Health Sciences Education, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based self-regulated simulation training (SRST) and Centralized instructor-regulated simulation training (IRST) in people with Educational Problems and Surgery, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 2 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 12 Feb 2021. 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 Denmark. 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?
Mean time for laparoscopic skills test (LASTT). (time frame: 0-7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2021.