Virtual Reality Training for Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-45
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
American Society of Anaesthesiologists (ASA) classification ≥ 4
Previous major open upper abdominal surgery
Suspicion for concomitant biliary disease (e.g. Mirizzi-Syndrome)
Robotic cholecystectomy
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual Reality training
Procedure/SurgeryIn 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).
Conventional training
Procedure/SurgeryIn the conventional study arm, the participants will view the preoperative MRCP.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality MRCPExperimental treatment 1 intervention
Group B: Conventional MRCPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Global 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)Secondary outcomes
1
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)2
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)3
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)4
Efficiency improvement
Discrepancy between actual and planned operative time
Time frame
On the day of surgery (within 12 hours)Other outcomes
1
Length of hospital stay
Length of the total hospital stay (days)
Time frame
At the day of discharge2
90-day postoperative Complications
All postoperative deviations from the normal expected course graded according to the Accordion classification and the comprehensive complication index.
Time frame
Until 90 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
University of Basel
Collaborator
Source ClinicalTrials.gov