Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study
LAPRA
1 other identifier
interventional
34
1 country
2
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedFirst Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedNovember 21, 2025
August 1, 2016
3.9 years
August 30, 2016
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig).
6 months (3 months after a second training session on the Pelvic Trainer)
Study Arms (2)
Pelvic Trainer without robotic assistance
ACTIVE COMPARATORInterns randomized to this arm will have two Pelvic Trainer training sessions three months apart. Intervention: Pelvic Trainer
Pelvic Trainer with robotic assistance
EXPERIMENTALInterns randomized to this arm will have two Pelvic Trainer training sessions three months apart but with robotic assistance. Intervention: Robotic assistance Intervention: Pelvic Trainer
Interventions
Robotic assistance will be implemented during Pelvic Trainer training sessions.
The standard Pelvic Trainer simulator for surgical training.
Eligibility Criteria
You may qualify if:
- Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)
You may not qualify if:
- The intern refuses to participate in the study
- The internal is not available for training and/or evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Related Publications (1)
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.
PMID: 25216348RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Letouzey, MD, PhD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 2, 2016
Study Start
February 1, 2012
Primary Completion
December 31, 2015
Study Completion
December 31, 2015
Last Updated
November 21, 2025
Record last verified: 2016-08