NCT02565875

Brief Summary

Obstetrics and Gynecology residents, fellows and attending physicians will be randomized to view one of two educational presentations of equal duration. The "intervention" presentation will demonstrate the use of a standardized language for effective communication of laparoscopy commands. Both groups will be asked to perform a simulated laparoscopic task. Participants will be timed and use of the standardized language will be tracked and tabulated. The primary outcome of interest is whether the use of standard commands during a simulated laparoscopic task is associated with sooner completion of the task. This may translate into improved efficiency in the operating room.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

September 30, 2015

Last Update Submit

February 9, 2016

Conditions

Procedure TimeCommunication

Keywords

Efficiency, OrganizationalSimulationCommunicationLaparoscopyMedical Education

Outcome Measures

Primary Outcomes (1)

  • Procedure Time

    The simulated laparoscopic task will be timed from initiation to completion

    Recorded once per simulated laparoscopic task upon completion (one visit)

Secondary Outcomes (1)

  • Communication

    Recorded during per simulated laparoscopic task (one visit)

Other Outcomes (1)

  • Post-Intervention Survey

    After completion of simulated laparoscopic task (one visit)

Study Arms (2)

SLL Presentation

EXPERIMENTAL

Intervention: Standardized Language of Laparoscopy (SLL) Presentation and simulated laparoscopic task performed on a low-fidelity pelvis simulator Will witness a presentation on the use of a SLL for communication between the primary and assistant surgeons during laparoscopy as previously determined by a national survey of Canadian experts and a modified delphi technique.

Behavioral: SLL PresentationOther: Simulated laparoscopic task

Control Presentation

PLACEBO COMPARATOR

Intervention: Surgical Anatomy (SA) Presentation and simulated laparoscopic task performed on a low-fidelity pelvis simulator Will witness a presentation of similar duration as the intervention group on laparoscopy but not related to communication (laparoscopic anatomy). The simulated laparoscopic task will be identical to the SLL group.

Behavioral: Control PresentationOther: Simulated laparoscopic task

Interventions

SLL PresentationBEHAVIORAL

Educational presentation on the use of a standardized lexicon for communication between surgeon and assistant during laparoscopy

SLL Presentation
Control PresentationBEHAVIORAL

Educational presentation on relevant anatomy related to laparoscopy performed by a gynecologic surgeon.

Control Presentation
Simulated laparoscopic taskOTHER

Using a low-fidelity pelvis simulator and laparoscopic instruments, pairs of each arm will be asked to perform a laparoscopic task (maneuver a ball into a nylon surgical bag). Use of SLL will be tabulated and task will be timed.

Control PresentationSLL Presentation

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstetrics and Gynecology Residents OR fellows OR attending physicians

You may not qualify if:

  • Physical disability preventing the candidate from performing laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Skills and Simulation Centre

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

  • Mehdizadeh, Mehra, et al. Standardizing Language in Laparoscopy: A Modified Delphi Approach. (Poster) AIME Day, The University of Ottawa, Canada

    RESULT

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Glenn D Posner, MDCM, FRCSC

    Medical Director of the University of Ottawa Skills and Simulation Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandrew Rajakumar, MD, FRCSC

CONTACT

1(613)290-2291crajakumar@toh.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Glenn D. Posner

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared, but will be available upon request as it will not contain any identifying data on the participant as determined through our institution's IRB.

Locations

CA(1)