NCT03363152

Brief Summary

Laparoscopic surgical suboptimal outcomes in patient safety measures are correlated with (i) cognitive load / level of attention of the operating surgeon, (ii) the frequency and degree of disruptions to the surgical workflow, and (iii) the misalignment of visual and motor axes in laparoscopic equipment / setting (eye-hand coordination).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 6, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

November 30, 2017

Last Update Submit

October 5, 2023

Conditions

Disturbance of Attention

Outcome Measures

Primary Outcomes (1)

  • surgeon´s attention

    surgeon´s attention during laparoscopic surgery

    july 2017 until December 2019

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

surgeons for General and Visceral surgery

You may qualify if:

  • laparoscopic cholecystectomy

You may not qualify if:

  • open surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler university clinic

Linz, Upper Austria, 4020, Austria

Location

Related Publications (3)

  • Ahmidi N, Hager GD, Ishii L, Fichtinger G, Gallia GL, Ishii M. Surgical task and skill classification from eye tracking and tool motion in minimally invasive surgery. Med Image Comput Comput Assist Interv. 2010;13(Pt 3):295-302. doi: 10.1007/978-3-642-15711-0_37.

    PMID: 20879412BACKGROUND

  • Atkins MS, Tien G, Khan RS, Meneghetti A, Zheng B. What do surgeons see: capturing and synchronizing eye gaze for surgery applications. Surg Innov. 2013 Jun;20(3):241-8. doi: 10.1177/1553350612449075. Epub 2012 Jun 13.

    PMID: 22696024BACKGROUND

  • Beatty J. Task-evoked pupillary responses, processing load, and the structure of processing resources. Psychol Bull. 1982 Mar;91(2):276-92. No abstract available.

    PMID: 7071262BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Dr. Bettina Klugsberger

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

July 6, 2016

Primary Completion

January 30, 2019

Study Completion

December 30, 2020

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)