Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions

NCT05037383 | Completed

• 1 other identifier: S65658
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sacrocolpopexy; Hysterectomy; Cesarean Section Complications

Keywords

Minimally invasive surgery; 3D visualization; Motion analysis

Outcome Measures

Primary Outcomes (4)

• Average number of people present in the operating room

  Number of people in the field of view of each camera at the same time. Visual assessment based on the recorded videos will be made.

  Duration of surgery

• Size and shape of the workspace (the space that is traveled) of the tracked people.

  Size of the workspace described in \[mm\] in x,y,z coordinates with respect to the cameras. This include average position and standard deviation in all three directions. The people being tracked are the surgeon, first assistant and the nurse handling the instrument. Tracking is done by placing visual markers on the head cap of the people that is being recorded by the cameras.

  Duration of surgery

• Distance of people from displays

  Distance of tracked people from the display they use in \[mm\]. Similarly as to workspace calculation, the distance will be calculated by means of video-based tracking of the people, using visual markers.

  Duration of surgery

• Direction of gaze of the tracked people

  Direction of gaze, i.e. direction where the person is looking, estimated based on head orientation. Head orientation is determined by using visual markers. Each visual marker has its own coordinate frame, from which the z axis determines where the marker is pointing. Since these will be placed on the head cap of the staff, the z axis of the marker will determine the direction of head orientation. Direction of gaze will be determined using a 3D vector \[x y z\] with origin of head position at each timestep.

  Duration of surgery

Secondary Outcomes (2)

• Movement of the display: Size and shape of the workspace of the displays.

  Duration of the surgery

• Illumination levels throughout the intervention.

  Duration of the surgery

Study Arms (1)

Study group

OTHER

Each participant will be part of the same group, since the study is focusing on the motion and viewing of the operating staff. There are no patient records collected.

Other: Video recordings

Interventions

Video recordings OTHER

The surgery of the patient will be recorded by cameras placed on the top of the displays used by the operating staff. The recordings will be only carried out while the patient is draped for the surgery, thus completely covered.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing either sacrocolpopexy or hysterectomy or cesarean scar defect repair
• For each operation to be eligible for the study, voluntary informed consent is required from all staff members involved

You may not qualify if:

• Not given informed consent by patient or any of the staff member involved in the operation

Sponsors & Collaborators

• prof. dr. Jan Deprest: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Jan Deprest, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 8, 2021
• Study Start: September 27, 2021
• Primary Completion: June 19, 2022
• Study Completion: June 19, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)