The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon
研究概览
简要总结
Cholecystectomy is one the most frequent laparoscopic procedures worldwide. It is a safe and effective operation but intraoperative bile duct injury remains a relevant complication with serious consequences for the patient. Most of the complications occur due to a lack of knowledge of the anatomy or misidentification of the cystic duct. Thus, the study of the anatomy is a cornerstone of a successful procedure and the preoperative magnetic resonance cholangiopancreatography (MRCP) is a way to preoperatively determine relevant structures to avoid intraoperative incidents.
This trial has been designed to assess the effect of preoperative virtual reality training based on MRCP on intraoperative performance and outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor and analyst
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for elective cholecystectomy for symptomatic cholecystolithiasis/chronic cholecystitis
- •Early cholecystectomy after acute biliary pancreatitis
- •Concomitant minor procedures (adhesiolysis, umbilical hernia repair, liver biopsy)
- •Sufficient quality of MRCP
排除标准
- •American Society of Anaesthesiologists (ASA) classification ≥ 4
- •Previous major open upper abdominal surgery
- •Suspicion for concomitant biliary disease (e.g. Mirizzi-Syndrome)
- •Robotic cholecystectomy
- •Planned open procedures
研究组 & 干预措施
Virtual Reality MRCP
The MRCP images will be transferred into a 3D VR rendering software (Specto VR TM) for each patient. Residents will have the opportunity to use the virtual reality environment the day before surgery until a sufficient understanding of the anatomy is achieved.
干预措施: Virtual Reality training (Procedure)
Conventional MRCP
Controls will have regular access to the conventional MRCP images.
干预措施: Conventional training (Procedure)
结局指标
主要结局
Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon
时间窗: On the day of surgery (within 12 hours)
For the global assessment of laparoscopic skills, the Global Operative Assessment of Laparoscopic Skills (GOALS) will be used. Evaluation will be performed by the attending surgeon. The GOALS is a 5 item rating scale and the items are scored using a 5-point Likert scale where "1" represents the lowest level of performance, and "5" is considered ideal performance. The total score for the global rating scale is the sum of the scores for each of the 5 items for a maximum total score of 25.
次要结局
- Operative time(During surgery)
- Self-confidence(On the day of surgery (within 12 hours))
- Intraoperative interventions by assisting surgeon(During surgery)
- Critical View of Safety(Postoperative within 30 days (Video-Analysis))
- Efficiency improvement(On the day of surgery (within 12 hours))
- Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident(On the day of surgery (within 12 hours))
- Time to critical view of safety(Postoperative within 30 days (Video-Analysis))