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Standardizing Language in Laparoscopic Surgery (SLL)

9 febbraio 2016 aggiornato da: Glenn Posner, Ottawa Hospital Research Institute

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • University of Ottawa Skills and Simulation Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 19 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Obstetrics and Gynecology Residents OR fellows OR attending physicians

Exclusion Criteria:

  • Physical disability preventing the candidate from performing laparoscopic surgery

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

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

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Procedure Time
Lasso di tempo: Recorded once per simulated laparoscopic task upon completion (one visit)
The simulated laparoscopic task will be timed from initiation to completion
Recorded once per simulated laparoscopic task upon completion (one visit)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Communication
Lasso di tempo: Recorded during per simulated laparoscopic task (one visit)
Tabulated instances of the use of SLL during simulated laparoscopic task from initiation to completion
Recorded during per simulated laparoscopic task (one visit)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-Intervention Survey
Lasso di tempo: After completion of simulated laparoscopic task (one visit)
Survey requesting qualitative data on experience and the effect of presentations on anxiety during simulated task
After completion of simulated laparoscopic task (one visit)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Glenn D Posner, MDCM, FRCSC, Medical Director of the University of Ottawa Skills and Simulation Centre

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2016

Completamento primario (Anticipato)

1 giugno 2016

Completamento dello studio (Anticipato)

1 giugno 2016

Date di iscrizione allo studio

Primo inviato

30 settembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

30 settembre 2015

Primo Inserito (Stima)

1 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 febbraio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 febbraio 2016

Ultimo verificato

1 febbraio 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 20150727-01H

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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