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OpenTrials
Completed

NCT Number: NCT02770937

Simulator Versus Box Trainer on Laparoscopic Suturing

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong, 000000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality simulator

Other

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

Other

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

Simbionix

Device

Primary outcomes

  1. The time to complete task

    Time frame: within 10 days after completion of training

  2. Surgeon's preference (modified GOALS questionnaire score)

    Time frame: Within 10 days after completion of training

  3. Objective score

    Time frame: Within 3 months after completion of training and assessment

    Scored by 2 experienced gynecological laparoscopists

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • The Hong Kong Jockey Club Charities Trust

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 12, 2016
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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