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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Surgical Training

Treatments: Other: Robotic assistance; Other: Pelvic Trainer

Study type: Interventional

Funder types: Other

Identifiers

NCT02888158

AOI/2011/VL-01

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Pelvic Trainer without robotic assistance

Active Comparator group

Description:

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

Treatment:

Other: Pelvic Trainer

Pelvic Trainer with robotic assistance

Experimental group

Description:

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

Treatment:

Other: Pelvic Trainer

Other: Robotic assistance