Simulator Versus Box Trainer on Laparoscopic Suturing

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT02770937
Collaborator
Hong Kong Jockey Club Innovative Learning Centre for Medicine (Other)
36
1
3
8
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality simulator
  • Other: Box trainer
  • Device: Simbionix
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
A Prospective Randomized Controlled Trial Comparing Virtual Reality Simulation Training and Box Trainer on the Acquisition of Laparoscopic Suturing Skills
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.

Device: Simbionix

Active Comparator: Box trainer

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
The box trainer group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) on a box trainer.

Device: Simbionix

No Intervention: Control

The control group will not receive further training.

Outcome Measures

Primary Outcome Measures

  1. The time to complete task [within 10 days after completion of training]

  2. Surgeon's preference (modified GOALS questionnaire score) [Within 10 days after completion of training]

  3. Objective score [Within 3 months after completion of training and assessment]

    Scored by 2 experienced gynecological laparoscopists

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong 000000

Sponsors and Collaborators

  • The University of Hong Kong
  • Hong Kong Jockey Club Innovative Learning Centre for Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02770937
Other Study ID Numbers:
  • HKUCTR-1920
First Posted:
May 12, 2016
Last Update Posted:
May 12, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by The University of Hong Kong

Study Results

No Results Posted as of May 12, 2016