Simulator Versus Box Trainer on Laparoscopic Suturing

Study Overview
=================
Brief Summary
-----------------
This is prospective randomized controlled study to compare the proficiency of novices in acquiring laparoscopic suturing skills following either training in a virtual reality simulator or box trainer.

Detailed Description
-----------------
Participants will be randomized into three groups by computer-generated sequence to the virtual reality simulator, box trainer and control groups. They will be shown a video demonstration and given simple instructions on laparoscopic suturing and intracorporeal knot tying at the beginning of the training. Both the virtual reality simulator and box trainer groups will be allowed a maximum of 4 hours of training (2 sessions of 2 hours each). The participants could terminate training at any time point during the 4-hour if they felt competent to perform the task.The control group will not receive any further training. They will then be asked to perform laparoscopic suturing (which would involve needle loading and insertion via 2 pre-marked circles, and knot tying which includes at least 2 single throws) on a box trainer. Participants will be asked to complete a modified GOALS questionnaire at the end (which will take around 5 minutes) to evaluate their experiences and assess their own proficiency. The procedure will also be recorded (with a number identifying the participant only) and assessment will be performed when the study is completed by 2 experienced laparoscopic gynecologists blinded to the participants who will review the recorded procedure. The time to complete each task, total procedural time and proficiency will be assessed, which will be compared against the participants' own evaluation.

Official Title
-----------------
A Prospective Randomized Controlled Trial Comparing Virtual Reality Simulation Training and Box Trainer on the Acquisition of Laparoscopic Suturing Skills

Conditions
-----------------
Simulation Training, Laparoscopy

Intervention / Treatment
-----------------
* Other: Virtual reality simulator
* Other: Box trainer
* Device: Simbionix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All trainees and interns working in the Department of Obstetrics and Gynecology who have (i) no laparoscopic experience or (ii) laparoscopic experience but no laparoscopic suturing experience, will be invited to participate in the study. Older than the age of legal consent (i.e. 18 years old) Willing and able to participate after the study has been explained Exclusion Criteria: - Cannot understand English, Cantonese or Putonghua
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual reality simulator<br>The virtual reality simulator group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) using the Simbionix simulator on laparoscopic suturing. | Other: Virtual reality simulator<br>* The virtual reality simulator group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) using the Simbionix simulator on laparoscopic suturing.<br>Device: Simbionix<br> <br> |
| Active Comparator: Box trainer<br>The box trainer group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) using the Simbionix simulator on box trainer. | Other: Box trainer<br>* The box trainer group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) on a box trainer.<br>Device: Simbionix<br> <br> |
| No Intervention: Control<br>The control group will not receive further training. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to complete task |  | within 10 days after completion of training | 
| Surgeon's preference (modified GOALS questionnaire score) |  | Within 10 days after completion of training | 
| Objective score | Scored by 2 experienced gynecological laparoscopists | Within 3 months after completion of training and assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, simulator