Standardizing Language in Laparoscopic Surgery

Communication Clinical Trial

— SLL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02565875
• Other study ID #: 20150727-01H
• Status: Not yet recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: February 9, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: Ottawa Hospital Research Institute
• Contact: Chandrew Rajakumar, MD, FRCSC
• Phone: 1(613)290-2291
• Email: crajakumar[@]toh.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Obstetrics and Gynecology Residents OR fellows OR attending physicians

Exclusion Criteria:

• Physical disability preventing the candidate from performing laparoscopic surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Communication
• Procedure Time

Intervention

Behavioral:
• SLL Presentation
Educational presentation on the use of a standardized lexicon for communication between surgeon and assistant during laparoscopy
• Control Presentation
Educational presentation on relevant anatomy related to laparoscopy performed by a gynecologic surgeon.

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.

Locations

Country	Name	City	State
Canada	University of Ottawa Skills and Simulation Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	Procedure Time	The simulated laparoscopic task will be timed from initiation to completion	Recorded once per simulated laparoscopic task upon completion (one visit)	No
Secondary	Communication	Tabulated instances of the use of SLL during simulated laparoscopic task from initiation to completion	Recorded during per simulated laparoscopic task (one visit)	No