Virtual Reality Clinical Trial
Official title:
The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study
NCT number | NCT05169073 |
Other study ID # | CU621 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2021 |
Est. completion date | June 30, 2025 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Centre for Gastrointesintal and Liver Disease | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | University of Basel |
Switzerland,
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. — View Citation
Nassar AHM, Ashkar KA, Mohamed AY, Hafiz AA. Is laparoscopic cholecystectomy possible without video technology? Minimally Invasive Therapy. 1995; 4:2 63-65
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Length of hospital stay | Length of the total hospital stay (days) | At the day of discharge | |
Other | 90-day postoperative Complications | All postoperative deviations from the normal expected course graded according to the Accordion classification and the comprehensive complication index. | Until 90 days after surgery | |
Primary | 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. | On the day of surgery (within 12 hours) | |
Secondary | 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). | On the day of surgery (within 12 hours) | |
Secondary | 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. | Postoperative within 30 days (Video-Analysis) | |
Secondary | Time to critical view of safety | Time required to achieve the CVS or i.e. until the clips are placed during the operation. | Postoperative within 30 days (Video-Analysis) | |
Secondary | Efficiency improvement | Discrepancy between actual and planned operative time | On the day of surgery (within 12 hours) | |
Secondary | 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. | On the day of surgery (within 12 hours) | |
Secondary | Operative time | Time from incision to wound closure | During surgery | |
Secondary | 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. | During surgery |
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