Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study (LAPRA)

November 18, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier - Hôpital Gui de Chauliac
      • Nîmes, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)

Exclusion Criteria:

  • The intern refuses to participate in the study
  • The internal is not available for training and/or evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pelvic Trainer without robotic assistance

Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart.

Intervention: Pelvic Trainer
Other: Pelvic Trainer
The standard Pelvic Trainer simulator for surgical training.
Experimental: Pelvic Trainer with robotic assistance

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
Other: Pelvic Trainer
The standard Pelvic Trainer simulator for surgical training.
Other: Robotic assistance
Robotic assistance will be implemented during Pelvic Trainer training sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
6 months (3 months after a second training session on the Pelvic Trainer)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Vincent Letouzey, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimated)

September 2, 2016

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • AOI/2011/VL-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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