Bile Duct Injury, Gallbladder, Laparoscopy, Medical Education, Virtual Reality
Conditions
Brief summary
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.
Interventions
PROCEDUREVirtual Reality training
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).
PROCEDUREConventional training
In the conventional study arm, the participants will view the preoperative MRCP.
Sponsors
University of Basel
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor and analyst
Intervention model description
The order in which the operations will be performed by each resident is random.
Eligibility
Sex/Gender
ALL
Age
22 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident | 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 resident (self-assessment). |
| Critical View of Safety | Postoperative within 30 days (Video-Analysis) | 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 to critical view of safety | Postoperative within 30 days (Video-Analysis) | Time required to achieve the CVS or i.e. until the clips are placed during the operation. |
| Efficiency improvement | On the day of surgery (within 12 hours) | Discrepancy between actual and planned operative time |
| Operative time | During surgery | Time from incision to wound closure |
| Intraoperative interventions by assisting surgeon | During surgery | Any intervention necessary to guide to resident. I.e. whenever the assisting surgeon takes over the position of the operating surgeon. |
| Self-confidence | On the day of surgery (within 12 hours) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | At the day of discharge | Length of the total hospital stay (days) |
| 90-day postoperative Complications | Until 90 days after surgery | All postoperative deviations from the normal expected course graded according to the Accordion classification and the comprehensive complication index. |
Countries
Switzerland
Contacts
Primary ContactChristoph Kuemmerli, MD
Outcome results
None listed