Surgical TrainingLAPRANCT02888158
Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study
A study testing Robotic assistance and Pelvic Trainer in people with Surgical Training, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Training
- What is being tested?
- Robotic assistance and Pelvic Trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2012to 31 Dec 2015
- 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
- Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)
Who cannot join
- The intern refuses to participate in the study
- The internal is not available for training and/or evaluation
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig).
The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.
- Conditions
- Surgical Training
- Being tested
- Robotic assistance, Pelvic Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assistanceOther
Robotic assistance will be implemented during Pelvic Trainer training sessions.
Pelvic TrainerOther
The standard Pelvic Trainer simulator for surgical training.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Trainer without robotic assistance | Active comparator | Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart.
Intervention: Pelvic Trainer Receives: Other: Pelvic Trainer |
| Pelvic Trainer with robotic assistance | Experimental | Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart but with robotic assistance.
Intervention: Robotic assistance
Intervention: Pelvic Trainer Receives: Other: Robotic assistance; Other: Pelvic Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig).
Measured: 6 months (3 months after a second training session on the Pelvic Trainer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startFeb 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888158
- Sponsor's protocol ID
- AOI/2011/VL-01
- Acronym
- LAPRA
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Letouzey V, Huberlant S, Faillie JL, Prudhomme M, Mares P, de Tayrac R. Evaluation of a laparoscopic training program with or without robotic assistance. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:321-7. doi: 10.1016/j.ejogrb.2014.08.003. Epub 2014 Aug 20.
PubMed 25216348
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study
- ClinicalTrials.gov ID
- NCT02888158
- Acronym / sponsor ID
- LAPRA / AOI/2011/VL-01
- Conditions
- Surgical Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 2 Sep 2016 (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.
The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig).
The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Trainer without robotic assistance | Active comparator | Other: Pelvic TrainerInterns randomized to this arm will have two Pelvic Trainer training sessions three months apart. Intervention: Pelvic Trainer |
| Pelvic Trainer with robotic assistance | Experimental | Other: Robotic assistance, Other: Pelvic TrainerInterns randomized to this arm will have two Pelvic Trainer training sessions three months apart but with robotic assistance. Intervention: Robotic assistance Intervention: Pelvic Trainer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)
Key exclusion criteria (2 listed)
- The intern refuses to participate in the study
- The internal is not available for training and/or evaluation
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 |
|---|---|---|
| Robotic assistanceRobotic assistance will be implemented during Pelvic Trainer training sessions. | Other | Pelvic Trainer with robotic assistance |
| Pelvic TrainerThe standard Pelvic Trainer simulator for surgical training. | Other | Pelvic Trainer with robotic assistance, Pelvic Trainer without robotic assistance |
Primary outcome
The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig).
Time frame: 6 months (3 months after a second training session on the Pelvic Trainer)
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 21 Nov 2025.
- Results publication: PubMed 25216348Letouzey V, Huberlant S, Faillie JL, Prudhomme M, Mares P, de Tayrac R. Evaluation of a laparoscopic training program with or without robotic assistance. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:321-7. doi: 10.1016/j.ejogrb.2014.08.003. Epub 2014 Aug 20.
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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.
Vincent Letouzey, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assistance and Pelvic Trainer in people with Surgical Training, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig). (time frame: 6 months (3 months after a second training session on the Pelvic Trainer)). 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 NCT02888158, 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 21 Nov 2025.