SurgeryNCT04989881
Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator
A study testing da Vinci Simulator and Laparascopic training box in people with Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- da Vinci Simulator and Laparascopic training box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2021to Jun 2025
- 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
- Medical student at the University of Geneva
Who cannot join
- Previous laparoscopic experience
- Stereoblindness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1211
Pouya Iranmanesh, MD, +41795533205, pouya.iranmanesh@hcuge.ch
Pouya Iranmanesh, MD
About this study
Official title: Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator Training to Develop Basic Laparoscopic Skills: A Randomized Clinical Trial
The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.
Read the detailed description
This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .
- Conditions
- Surgery
- Being tested
- da Vinci Simulator, Laparascopic training box
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci SimulatorDevice
Single training session
Laparascopic training boxDevice
Single training session
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci Simulator | Experimental | Participants will undergo a single session of training using the da Vinci Simulator Receives: Device: da Vinci Simulator |
| Laparascopic training box | Active comparator | Participants will undergo a single session of training using a laparoscopic training box Receives: Device: Laparascopic training box |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLS score post-training session
This score is a composite outcome combining the time needed to finish the exercises and the proficiency in performing them (number of dropped objects, lack of movements precision, exercises rules violations, etc.). The score will go from 0 (worst score) to 800 (best score), with a passing score of 356.
Measured: Up to 1 hour after the beginning of the exam session.
Secondary outcomes (1)
Times needed to perform training exercises
Time required to perform the training exercises will be measured in both groups (dry-lab laparoscopic box and da Vinci skills simulator)
Measured: Up to 1 hour after the beginning of the training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start15 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completionJun 2025 (estimated)
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 SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouya Iranmanesh, University Hospital, Geneva
- Investigators
- Pouya Iranmanesh, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989881
- Sponsor's protocol ID
- University of Geneva
- Status last verified
- May 2024
- First submitted
- 7 Apr 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocha M, Bouhalassa N, Shahinfar K, Toso C, Moeckli B, Iranmanesh P. Robotic versus laparoscopic simulation training for laparoscopic skill acquisition in novices: a randomized controlled trial. Surg Endosc. 2026 Sep 29. doi: 10.1007/s00464-026-13418-9. Online ahead of print.
PubMed 42811179
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator Training to Develop Basic Laparoscopic Skills: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04989881
- Acronym / sponsor ID
- University of Geneva
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Aug 2021 (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 objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.
Detailed description
This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Da Vinci Simulator | Experimental | Device: da Vinci SimulatorParticipants will undergo a single session of training using the da Vinci Simulator |
| Laparascopic training box | Active comparator | Device: Laparascopic training boxParticipants will undergo a single session of training using a laparoscopic training box |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student at the University of Geneva
Key exclusion criteria (2 listed)
- Previous laparoscopic experience
- Stereoblindness
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 |
|---|---|---|
| da Vinci SimulatorSingle training session | Device | Da Vinci Simulator |
| Laparascopic training boxSingle training session | Device | Laparascopic training box |
Primary outcome
FLS score post-training session
Time frame: Up to 1 hour after the beginning of the exam session.
This score is a composite outcome combining the time needed to finish the exercises and the proficiency in performing them (number of dropped objects, lack of movements precision, exercises rules violations, etc.). The score will go from 0 (worst score) to 800 (best score), with a passing score of 356.
1 secondary outcome
Times needed to perform training exercises
Time frame: Up to 1 hour after the beginning of the training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 42811179Rocha M, Bouhalassa N, Shahinfar K, Toso C, Moeckli B, Iranmanesh P. Robotic versus laparoscopic simulation training for laparoscopic skill acquisition in novices: a randomized controlled trial. Surg Endosc. 2026 Sep 29. doi: 10.1007/s00464-026-13418-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Pouya Iranmanesh, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci Simulator and Laparascopic training box in people with Surgery, run by University Hospital, Geneva 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 1 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: status not confirmed, as of the sponsor's last update on 16 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pouya Iranmanesh, MD (+41795533205, pouya.iranmanesh@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLS score post-training session (time frame: Up to 1 hour after the beginning of the exam session.). 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 NCT04989881, 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 16 May 2024.