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Simulator Versus Box Trainer on Laparoscopic Suturing

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ClinicalTrials.gov Identifier: NCT02770937
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Hong Kong Jockey Club Innovative Learning Centre for Medicine
Information provided by (Responsible Party):
The University of Hong Kong

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
Simulation Training, Laparoscopy Other: Virtual reality simulator Other: Box trainer Device: Simbionix Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

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.



Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770937


Locations
Hong Kong
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

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02770937     History of Changes
Other Study ID Numbers: HKUCTR-1920
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Hong Kong:
laparoscopy, simulator