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

Not Applicable

Completed

• Conditions: Surgical Training
• Interventions: Other: Pelvic Trainer; Other: Robotic assistance

• Registration Number: NCT02888158
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-08-30
• Last Update Submitted: 2016-08-30
• Study First Posted: 2016-09-02
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Trainer without robotic assistance	Pelvic Trainer	Interns randomized to this arm will have two Pelvic Trainer training sessions three months apart. Intervention: Pelvic Trainer
Pelvic Trainer with robotic assistance	Pelvic Trainer	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
Pelvic Trainer with robotic assistance	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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

CHU de Montpellier - Hôpital Gui de Chauliac; 🇫🇷 Montpellier Cedex 5, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France