Laparoscopic Roux-en-y Gastric Bypass Clinical Trial
Official title:
A Prospective, Post Market, Feasibility Study to Assess the Practical Utility of the OR BlackBox Platform When Used to Compare Surgical Technique During 2D Versus 3D Laparoscopic Bariatric Surgery
This is a hypothesis generating pilot study to compare the impact of 2D versus 3D visualization on surgical performance, as measured by the OR BlackBox platform, during laparoscopic bariatric surgery.
Data published in 2008 estimated the global number of surgical procedures performed annually
as 234 million with a rate of major perioperative complications reported between 3% and 17%
in industrialized countries. As a derivative of these figures, it is estimated that
approximately 7 to 40 million major complications occur worldwide each year. Studies have
shown that between 39.6% and 54.2% of surgical complications occur in the operating room
(OR); furthermore, it has been suggested that one third to half of all surgical errors are
potentially avoidable. These findings have brought considerable attention to quality
improvement in the technically demanding field of laparoscopic surgery wherein the risk of
intraoperative error is increased by the sociotechnical complexity of the operative
environment. In particular, there has been growing interest in evaluating surgical processes
from a human factors point of view, as human factors, such as fatigue and mental workload,
have become increasingly recognized as root causes of adverse surgical events and outcomes.
Among the most commonly reported errors in conventional laparoscopic surgery are technical
errors associated with impaired depth perception; laparoscopic surgeons rely on
two-dimensional (2D) video displays to guide their work in a three-dimensional (3D) space,
resulting in the loss of depth perception and spatial orientation, as well as the experience
of increased visual and cognitive load. Technical errors can be defined as manual errors of
the surgeon (e.g. damage to adjacent structures) and procedural errors due to a lack of
surgeon proficiency or experience. These errors are frequently described, especially when
evaluating closed malpractice cases. These factors have been extensively examined but still
remain controversial. A major limitation of error analyses of closed malpractice cases and
root cause analyses of complications is the hindsight bias introduced through the knowledge
of patient outcome.
Laparoscopic cameras with 3D display functionality were first developed in the early 1990s.
The poor image quality produced by early cameras resulted in pronounced physical side
effects, including dizziness, headache, and nausea; however, a significant technological
advancement in the field of 3D laparoscopy has dramatically improved the usability of these
systems. Despite these improvements and the potential for improved surgical safety, the use
of 3D laparoscopic equipment remains limited in modern surgical centers. Outdated and
conflicting research findings regarding the effectiveness of these systems and the physical
side effects associated with their use may be contributing to slow adoption into clinical
practice. Furthermore, investigations assessing the impact of 3D laparoscopy on surgical
performance in the clinical setting are notably lacking. Thus, robust comparative evaluations
of modern 2D and 3D laparoscopic surgical display systems in clinical settings are required
to clearly elucidate the impact of 3D laparoscopy on surgical performance and safety with an
aim to establish best practices in laparoscopic surgery.
The restoration of stereoscopic vision in laparoscopic surgery has the potential to mitigate
these challenges and, to this end, the introduction of 3D stereoscopic displays in
laparoscopic surgery may be beneficial to improving surgical safety. The purpose of this
study is to compare the impact of 2D versus 3D visualization on surgical performance, as
measured by the OR BlackBox Platform, during laparoscopic Roux-en-Y gastric bypass surgery.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02008409 -
Evaluation of Safety and Efficacy of the EndoLift Liver Retractor
|
N/A |