Clinical trial NCT05169073: Virtual Reality Training for Laparoscopic Cholecystectomy
Official title: The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Gallbladder
Bile Duct Injury
Medical Education
Laparoscopy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2021-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The order in which the operations will be performed by each resident is random.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Global Assessment of Laparoscopic Skills (GOALS) score assessed by assisting surgeon
timeFrame: On the day of surgery (within 12 hours)
Secondary outcomes:
measure: Global Assessment of Laparoscopic Skills (GOALS) score assessed by resident
timeFrame: On the day of surgery (within 12 hours)
measure: Critical View of Safety
timeFrame: Postoperative within 30 days (Video-Analysis)
measure: Time to critical view of safety
timeFrame: Postoperative within 30 days (Video-Analysis)
measure: Efficiency improvement
timeFrame: On the day of surgery (within 12 hours)
measure: Self-confidence
timeFrame: On the day of surgery (within 12 hours)
measure: Operative time
timeFrame: During surgery
measure: Intraoperative interventions by assisting surgeon
timeFrame: During surgery
Other outcomes:
measure: Length of hospital stay
timeFrame: At the day of discharge
measure: 90-day postoperative Complications
timeFrame: Until 90 days after surgery
Locations:
city: Basel
country: Switzerland
facility: University Centre for Gastrointesintal and Liver Disease
Study officials:
affiliation: Clarunis - University Center for Gastrointestinal and Liver Diseases
name: Sebastian Staubli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nassar AHM, Ashkar KA, Mohamed AY, Hafiz AA. Is laparoscopic cholecystectomy possible without video technology? Minimally Invasive Therapy. 1995; 4:2 63-65
citation: Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004.
citation: Sanford DE, Strasberg SM. A simple effective method for generation of a permanent record of the Critical View of Safety during laparoscopic cholecystectomy by intraoperative "doublet" photography. J Am Coll Surg. 2014 Feb;218(2):170-8. doi: 10.1016/j.jamcollsurg.2013.11.003. Epub 2013 Nov 9.
citation: Geoffrion R, Lee T, Singer J. Validating a self-confidence scale for surgical trainees. J Obstet Gynaecol Can. 2013 Apr;35(4):355-361. doi: 10.1016/S1701-2163(15)30964-6.