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

NCT ID: NCT02888158

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pelvic Trainer without robotic assistance

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

Intervention: Pelvic Trainer

Group Type ACTIVE_COMPARATOR

Pelvic Trainer

Intervention Type OTHER

The standard Pelvic Trainer simulator for surgical training.

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

Group Type EXPERIMENTAL

Robotic assistance

Intervention Type OTHER

Robotic assistance will be implemented during Pelvic Trainer training sessions.

Pelvic Trainer

Intervention Type OTHER

The standard Pelvic Trainer simulator for surgical training.

Interventions

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Robotic assistance

Robotic assistance will be implemented during Pelvic Trainer training sessions.

Intervention Type OTHER

Pelvic Trainer

The standard Pelvic Trainer simulator for surgical training.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Letouzey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25216348 (View on PubMed)

Other Identifiers

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AOI/2011/VL-01

Identifier Type: -

Identifier Source: org_study_id

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