NCT02770937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 3, 2016

Last Update Submit

May 11, 2016

Conditions

Simulation Training, Laparoscopy

Keywords

laparoscopy, simulator

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Virtual reality simulator

ACTIVE COMPARATOR

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 simulatorDevice: Simbionix

Box trainer

ACTIVE COMPARATOR

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 trainerDevice: Simbionix

Control

NO INTERVENTION

The control group will not receive further training.

Interventions

Virtual reality simulatorOTHER

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.

Virtual reality simulator
Box trainerOTHER

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

Box trainer
SimbionixDEVICE
Box trainerVirtual reality simulator

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Cannot understand English, Cantonese or Putonghua

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 12, 2016

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)