The BlackBox Study

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Roux-en-y Gastric Bypass
• Intervention / Treatment: Procedure: Laparoscopic Roux-en-y Gastric Bypass Surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B
      • St. Michael's Hospital, Division of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment in this study.

Description

Inclusion Criteria:

1. ≥ 18 years of age
2. Scheduled to undergo elective, primary roux-en-y gastric bypass surgery
3. BMI of 35 to 54.9
4. Willing and able to provide informed consent

Exclusion Criteria:

1. Previous open abdominal surgery
2. Previous open or laparoscopic upper GI surgery
3. Contraindicated for laparoscopic bariatric surgery
4. Unable or unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2D laparoscopic surgeries; Two-Dimensional Laparascopic Surgical Video System	Procedure: Laparoscopic Roux-en-y Gastric Bypass Surgery; Laparoscopic Roux-en-y Gastric Bypass Surgery
3D laparoscopic surgeries; Three-Dimensional Laparascopic Surgical Video System	Procedure: Laparoscopic Roux-en-y Gastric Bypass Surgery; Laparoscopic Roux-en-y Gastric Bypass Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify operative performance and intraoperative errors	This pilot study will quantify operative performance and intraoperative errors after the introduction of the 2D and 3D technology using the following tools: Generic Error Rating Tool (GERT); Objective Structured Assessment of Technical Skill (OSATS)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant adverse events	1. Clinically significant adverse events related to the device(s) and/or procedure	one month

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas
• Collaborators: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): March 11, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: 2D laparoscopic surgery; 3D laparascopic surgery; laparoscopic roux-en-y gastric bypass
• Other Study ID Numbers: 2015-SE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No