Simulator Versus Box Trainer on Laparoscopic Suturing

Simulation Training, Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770937
• Other study ID #: HKUCTR-1920
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: May 11, 2016
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Simulation Training, Laparoscopy

Intervention

Other:
• Virtual reality simulator
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.
• Box trainer
The box trainer group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) on a box trainer.

Device:
• Simbionix

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Jockey Club Innovative Learning Centre for Medicine

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to complete task		within 10 days after completion of training	No
Primary	Surgeon's preference (modified GOALS questionnaire score)		Within 10 days after completion of training	No
Primary	Objective score	Scored by 2 experienced gynecological laparoscopists	Within 3 months after completion of training and assessment	No