Procedure TimeSLLNCT02565875
Standardizing Language in Laparoscopic Surgery
A study testing SLL Presentation and Simulated laparoscopic task in people with Procedure Time and Communication, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedure Time, Communication
- What is being tested?
- SLL Presentation and Simulated laparoscopic task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obstetrics and Gynecology Residents OR fellows OR attending physicians
Who cannot join
- Physical disability preventing the candidate from performing laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ottawa Skills and Simulation Centre
Ottawa, Ontario, K1Y 4E9
Kim Tardioli, RPN, 1(613) 798-5555 ext. 19053, ktardioli@toh.on.ca
Chandrew Rajakumar, MD, FRCSC
About this study
Official title: 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.
Read the 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.
- Conditions
- Procedure Time, Communication
- Being tested
- SLL Presentation, Control Presentation, Simulated laparoscopic task
- Keywords
- Efficiency, Organizational, Simulation, Communication, Laparoscopy, Medical Education
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLL PresentationBehavioural
Educational presentation on the use of a standardized lexicon for communication between surgeon and assistant during laparoscopy
Control PresentationBehavioural
Educational presentation on relevant anatomy related to laparoscopy performed by a gynecologic surgeon.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SLL Presentation; Other: 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. Receives: Behavioral: Control Presentation; Other: Simulated laparoscopic task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time
The simulated laparoscopic task will be timed from initiation to completion
Measured: Recorded once per simulated laparoscopic task upon completion (one visit)
Secondary outcomes (1)
Communication
Tabulated instances of the use of SLL during simulated laparoscopic task from initiation to completion
Measured: Recorded during per simulated laparoscopic task (one visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedure TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Posner, Ottawa Hospital Research Institute
- Investigators
- Glenn D Posner, MDCM, FRCSC, Principal investigator, Medical Director of the University of Ottawa Skills and Simulation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565875
- Sponsor's protocol ID
- 20150727-01H
- Acronym
- SLL
- Status last verified
- Feb 2016
- First submitted
- 30 Sep 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
Mehdizadeh, Mehra, et al. Standardizing Language in Laparoscopy: A Modified Delphi Approach. (Poster) AIME Day, The University of Ottawa, Canada
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Standardizing Language in Laparoscopic Surgery Improve Efficiency? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02565875
- Acronym / sponsor ID
- SLL / 20150727-01H
- Conditions
- Procedure Time, Communication
- Keywords
- Efficiency, Organizational, Simulation, Communication, Laparoscopy, Medical Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLL Presentation | Experimental | Behavioral: SLL Presentation, Other: Simulated laparoscopic taskIntervention: 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. |
| Control Presentation | Placebo comparator | Behavioral: Control Presentation, Other: Simulated laparoscopic taskIntervention: 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obstetrics and Gynecology Residents OR fellows OR attending physicians
Key exclusion criteria (1 listed)
- Physical disability preventing the candidate from performing laparoscopic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLL PresentationEducational presentation on the use of a standardized lexicon for communication between surgeon and assistant during laparoscopy | Behavioural | SLL Presentation |
| Control PresentationEducational presentation on relevant anatomy related to laparoscopy performed by a gynecologic surgeon. | Behavioural | Control Presentation |
| Simulated laparoscopic taskUsing 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. | Other | Control Presentation, SLL Presentation |
Primary outcome
Procedure Time
Time frame: Recorded once per simulated laparoscopic task upon completion (one visit)
The simulated laparoscopic task will be timed from initiation to completion
1 secondary outcome
Communication
Time frame: Recorded during per simulated laparoscopic task (one visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Results publicationMehdizadeh, Mehra, et al. Standardizing Language in Laparoscopy: A Modified Delphi Approach. (Poster) AIME Day, The University of Ottawa, Canada
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn D Posner, MDCM, FRCSC principal investigator
Medical Director of the University of Ottawa Skills and Simulation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLL Presentation and Simulated laparoscopic task in people with Procedure Time and Communication, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chandrew Rajakumar, MD, FRCSC (1(613)290-2291, crajakumar@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Time (time frame: Recorded once per simulated laparoscopic task upon completion (one visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.