NCT03252470

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

August 11, 2017

Last Update Submit

August 12, 2019

Conditions

Laparoscopic Roux-en-y Gastric Bypass

Keywords

2D laparoscopic surgery3D laparascopic surgerylaparoscopic roux-en-y gastric bypass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Significant adverse events

    one month

Study Arms (2)

2D laparoscopic surgeries

Two-Dimensional Laparascopic Surgical Video System

Procedure: Laparoscopic Roux-en-y Gastric Bypass Surgery

3D laparoscopic surgeries

Three-Dimensional Laparascopic Surgical Video System

Procedure: Laparoscopic Roux-en-y Gastric Bypass Surgery

Interventions

Laparoscopic Roux-en-y Gastric Bypass SurgeryPROCEDURE

Laparoscopic Roux-en-y Gastric Bypass Surgery

2D laparoscopic surgeries3D laparoscopic surgeries

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Previous open abdominal surgery
  • Previous open or laparoscopic upper GI surgery
  • Contraindicated for laparoscopic bariatric surgery
  • Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital, Division of Surgery

Toronto, Ontario, M5B, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 17, 2017

Study Start

February 6, 2018

Primary Completion

March 11, 2019

Study Completion

March 20, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

CA(1)