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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
In the Virtual Reality (VR) study arm, a VR software (Specto VRTM, version 4.0, Diffuse Ltd, Heimberg, Switzerland) will be used to display volumetric MRCP data using a tethered head-mounted display (HMD) prior to the operation. Specto uses volume rendering at 180 frames/sec to visualize the medical data in an immersive fashion in the VR environment and allows for viewing of the 3D reconstructed 3D imaging with 360° free movement. Each participant will perform a procedure with VR training and one with conventional preparation (MRCP).
In the conventional study arm, the participants will view the preoperative MRCP.
University Centre for Gastrointesintal and Liver Disease
Basel, Switzerland
RECRUITINGGlobal Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon
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.
Time frame: On the day of surgery (within 12 hours)
Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident
For the global assessment of laparoscopic skills, the Global Operative Assessment of Laparoscopic Skills (GOALS) will be used. Evaluation will be performed by the resident (self-assessment).
Time frame: On the day of surgery (within 12 hours)
Critical View of Safety
The "Sanford-Strasberg' Critical-view-of-safety (CVS)" is a method for judging the CVS objectively through intraoperative photographs. It evaluates the CVS captured by anterior and posterior ("doublet") views. The minimum score is 0, and the maximum is 6. The higher the score, the more satisfactory is the CVS. The "Sanford-Strasberg' CVS Score" is useful in evaluating the CVS in video records and the CVS has been recognized as an essential and effective security method to reduce the risk of bile duct injury.
Time frame: Postoperative within 30 days (Video-Analysis)
Time to critical view of safety
Time required to achieve the CVS or i.e. until the clips are placed during the operation.
Time frame: Postoperative within 30 days (Video-Analysis)
Efficiency improvement
Discrepancy between actual and planned operative time
Time frame: On the day of surgery (within 12 hours)
Self-confidence
The self-confidence scale is a psychometrically valid tool to measure residents' self-confidence during surgical learning. Self-rating will be performed by selection of 6 items, each on a Likert scale ranging from 1 to 5. The maximum score attainable is 30 and the higher the score, the higher the self-confidence.
Time frame: On the day of surgery (within 12 hours)
Operative time
Time from incision to wound closure
Time frame: During surgery
Intraoperative interventions by assisting surgeon
Any intervention necessary to guide to resident. I.e. whenever the assisting surgeon takes over the position of the operating surgeon.
Time frame: During surgery
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