NCT05037383: MOVIE

Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions

Completed NA Last updated 3 November 2022

What this trial tests

NA trial testing Video recordings in Sacrocolpopexy in 20 participants. Completed in 19 June 2022.

Timeline

27 September 2021

Primary endpoint
19 June 2022

19 June 2022

Quick facts

Lead sponsor	prof. dr. Jan Deprest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	27 September 2021
Primary completion	19 June 2022
Estimated completion	19 June 2022
Sites	1 location across Belgium

Drugs / interventions tested

• Video recordings

Conditions studied

• Sacrocolpopexy — all drugs for Sacrocolpopexy →
• Hysterectomy — all drugs for Hysterectomy →
• Cesarean Section Complications — all drugs for Cesarean Section Complications →

Sponsor

prof. dr. Jan Deprest

Who can join

18 and older, female only, with Sacrocolpopexy or Hysterectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

During minimally invasive surgery (MIS), surgeons manipulate sharp and stiff instruments in the vicinity of fragile tissue, blood vessels, and critical nerves, where poor depth perception can have dramatic consequences. Since typically, 2-dimensional visualization is offered, to correctly infer the 3rd dimension, surgeons rely on their anatomical knowledge and experience. During unforeseen events, correct depth information can make the difference between success and failure. This explains the steep and long learning curve for surgeons. The absence of proper depth information slows down execution and leads to an unnecessary large mental load.

A recent document from the European Association of Endoscopic Surgery showed that 3D shortens operative time and learning curves and reduces complications. 'What the best way is to visualize 3D content' remains an open question. Near-to-eye displays provide small screens in front of each eye, while stereoscopic displays use glasses to project the 3D content to the eyes. The Da Vinci surgical system uses two individual optical panels. These systems are bulky, or restrict head movement, thus users have remarks on the ergonomics. The glasses for stereoscopic displays obscure the view, reduce brightness, and alter the color. Correct color is crucial to recognize tissue types and details or parts in shaded areas. Stereoscopic 3D displays lead to headache and eye-fatigue, called visually induced motion sickness in 11-22% of surgeons after several surgeries.

Autostereoscopic Visualization (ASV) is appealing for medical applications. Besides the improvement of depth perception, it allows 'glasses-free' operation. One of the key components of such displays is eye-tracking, that locates the eyes of the user to be able to render the 3D image to that viewpoint. ASV is a single-viewer application, which can be challenging in an operating room, with multiple people present. Therefore, a rigorous investigation is needed to maximize the performance of the algorithm and ensure the quality of service needed for medical use. It is crucial to collect data from real scenarios by recording the operation, the pose, motion of surgeons and the entire staff. These recordings will deliver solid understanding of the circumstances and rate of occurrences where eye-tracking and 3D visualization fails (or could fail). Furthermore, patterns can be recognized that could help to develop a robust eye-tracking algorithm and safety features for ASV.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.