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

Surgical Training Clinical Trial

— LAPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888158
• Other study ID #: AOI/2011/VL-01
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: August 30, 2016
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Surgical Training

Intervention

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

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Gui de Chauliac	Montpellier Cedex 5
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No