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临床试验/NCT02770937
NCT02770937已完成不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Objective score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •Cannot understand English, Cantonese or Putonghua

研究组 & 干预措施

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.

干预措施: Virtual reality simulator (Other)

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.

干预措施: Simbionix (Device)

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.

干预措施: Box trainer (Other)

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.

干预措施: Simbionix (Device)

Control

No Intervention

The control group will not receive further training.

结局指标

主要结局

Objective score

时间窗: Within 3 months after completion of training and assessment

Scored by 2 experienced gynecological laparoscopists

Surgeon's preference (modified GOALS questionnaire score)

时间窗: Within 10 days after completion of training

The time to complete task

时间窗: within 10 days after completion of training

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Simulator Versus Box Trainer on Laparoscopic Suturing | 临床试验