Virtual Reality Training for Laparoscopic Cholecystectomy

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05169073
Collaborator
University of Basel (Other)
20
Enrollment
1
Location
2
Arms
5.9
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Virtual Reality training
  • Procedure: Conventional training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The order in which the operations will be performed by each resident is random.The order in which the operations will be performed by each resident is random.
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes Assessor and analyst
Primary Purpose:
Prevention
Official Title:
The Impact of 3D Virtual Reality MRCP Rendering on Surgical Performance During Laparoscopic Cholecystectomy: A Pilot Study
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Virtual Reality MRCP

The MRCP images will be transferred into a 3D VR rendering software (Specto VR TM) for each patient. Residents will have the opportunity to use the virtual reality environment the day before surgery until a sufficient understanding of the anatomy is achieved.

Procedure: Virtual 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).

Active Comparator: Conventional MRCP

Controls will have regular access to the conventional MRCP images.

Procedure: Conventional training
In the conventional study arm, the participants will view the preoperative MRCP.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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).

  2. 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.

  3. 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.

  4. Efficiency improvement [On the day of surgery (within 12 hours)]

    Discrepancy between actual and planned operative time

  5. 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.

  6. Operative time [During surgery]

    Time from incision to wound closure

  7. 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.

Other Outcome Measures

  1. Length of hospital stay [At the day of discharge]

    Length of the total hospital stay (days)

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University Centre for Gastrointesintal and Liver DiseaseBaselSwitzerland4058

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland
  • University of Basel

Investigators

  • Principal Investigator: Sebastian Staubli, MD, Clarunis - University Center for Gastrointestinal and Liver Diseases

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05169073
Other Study ID Numbers:
  • CU621
First Posted:
Dec 23, 2021
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 23, 2021