Standardizing Language in Laparoscopic Surgery (SLL)

Does Standardizing Language in Laparoscopic Surgery Improve Efficiency? A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Communication; Procedure Time
• Intervention / Treatment: Behavioral: SLL Presentation; Other: Simulated laparoscopic task; Behavioral: Control Presentation

Detailed Description

Background

Continuous communication between the primary surgeon and assistant(s) during laparoscopic surgery is essential. The primary surgeon is rarely in direct control of the laparoscope and visual field. The use of a standard vernacular during surgery to provide clear instructions across all surgical centers is currently not employed. As the theoretical benefits of this are clear, a national survey produced a lexicon of commands1. Despite making intuitive sense, there is presently no evidence to demonstrate a benefit from using this standardized language during laparoscopic surgery. We aim to show that in doing so, there will be a significant improvement in speed and efficiency when performing a complex laparoscopic task.

Objective

To explore whether standardization of communication between the primary surgeon and the assistant in a simulated laparoscopic environment decreases the time needed to perform a complex task.

Materials and Methods

All subjects will provide demographic data, which will be collected through a brief questionnaire. This questionnaire will collect information regarding level of training or years of practice, as well as handedness. Personal identifying information (PII) will not be collected.

Subjects will be block randomized into control and intervention groups by random number generation. Block randomization will preserve equivalent distribution of level of training or years in practice into each group. Secondarily, handedness will be evenly distributed among groups, but not superseding level of training or years in practice.

The intervention group will receive a presentation on the standardized laparoscopic lexicon (SLL) (Mehdizadeh et al). The presentation will focus on sections 1-3 (surgical roles, camera commands and instrument commands).

The control group will receive no pre-task presentation.

Members within each group will be assigned a laparoscopic trainer by random allocation (blinded selection of card denoting station assignment). Through this, each trainer will have 2 subjects of the same group randomly assigned to it. These subjects will be referred to as the "primary surgeon" and "assistant". Assignment of initial roles will be done randomly. A member in each pair will be assigned the role denoted on a card he/she chooses blindly.

Pairs will be provided the task of placing a ball into a bag and closing the opening through tensioning the drawstring. This task must be performed using only laparoscopic graspers and will be timed by invigilators.

The ball will be approximately the same diameter as the bag opening and large enough to require camera adjustments. This task is not a commonly practiced laparoscopic skill such as suturing or knot tying (therefore should be less influenced by level of training) and should require communication between "primary surgeon" and "assistant" to accomplish in a timely fashion. The task is complex and should require sufficient time to detect a difference between groups.

Data collection within each group will include each pair's time to completion of the task and level of training/years in practice of "primary surgeon" and "assistant". Invigilators will track the usage of SLL during the task in both groups.

After a break, the roles will be reversed and the task repeated. The same data will be collected.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chandrew Rajakumar, MD, FRCSC; Phone Number: 1(613)290-2291; Email: crajakumar@toh.on.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • University of Ottawa Skills and Simulation Centre
      • Contact: Kim Tardioli, RPN; Phone Number: 19053 1(613) 798-5555; Email: ktardioli@toh.on.ca
      • Sub-Investigator: Chandrew Rajakumar, MD, FRCSC
      • Sub-Investigator: Adam Garber, MD, FRCSC
      • Sub-Investigator: Hassan Shenassa, MD, FRCSC
      • Sub-Investigator: Karine Lortie, MD, FRCSC
      • Sub-Investigator: Sukhbir Singh, MD, FRCSC
      • Principal Investigator: Glenn Posner, MDCM, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obstetrics and Gynecology Residents OR fellows OR attending physicians

Exclusion Criteria:

• Physical disability preventing the candidate from performing laparoscopic surgery

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLL Presentation; 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 Presentation; Educational presentation on the use of a standardized lexicon for communication between surgeon and assistant during laparoscopy; Other: Simulated laparoscopic task; 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.
Placebo Comparator: Control Presentation; 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.	Other: Simulated laparoscopic task; 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.; Behavioral: Control Presentation; Educational presentation on relevant anatomy related to laparoscopy performed by a gynecologic surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	The simulated laparoscopic task will be timed from initiation to completion	Recorded once per simulated laparoscopic task upon completion (one visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication	Tabulated instances of the use of SLL during simulated laparoscopic task from initiation to completion	Recorded during per simulated laparoscopic task (one visit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Intervention Survey	Survey requesting qualitative data on experience and the effect of presentations on anxiety during simulated task	After completion of simulated laparoscopic task (one visit)

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Glenn D Posner, MDCM, FRCSC, Medical Director of the University of Ottawa Skills and Simulation Centre

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 9, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Medical Education; Communication; Laparoscopy; Simulation; Efficiency, Organizational
• Other Study ID Numbers: 20150727-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.