- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02565875
Standardizing Language in Laparoscopic Surgery (SLL)
Does Standardizing Language in Laparoscopic Surgery Improve Efficiency? A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
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
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4E9
- University of Ottawa Skills and Simulation Centre
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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
Investigatori
- Investigatore principale: Glenn D Posner, MDCM, FRCSC, Medical Director of the University of Ottawa Skills and Simulation Centre
Pubblicazioni e link utili
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
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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)?
Descrizione del piano IPD
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 .
Prove cliniche su SLL Presentation
-
University of MiamiBlood Cancer UnitedReclutamentoLinfoma | Sindromi mielodisplastiche | Leucemia | Mieloma | Neoplasia mieloproliferativaStati Uniti
-
University of JordanCompletatoPreferenza del paziente | Corrispondenza dell'ombra | Percezione Estetica | Colore dei dentiGiordania
-
The Affiliated Hospital of Xuzhou Medical UniversityReclutamentoCLL | SL | Terapia cellulare CAR-TCina
-
Hoffmann-La RocheCompletato
-
Merck Sharp & Dohme LLCReclutamentoCancro colorettale | Adenocarcinoma duttale pancreatico | Cancro delle vie biliariStati Uniti, Taiwan, Giappone, Australia, Spagna, Regno Unito, Italia, Cina, Canada, Chile, Corea del Sud, Svizzera, Turchia (Türkiye)
-
Janssen Research & Development, LLCReclutamentoNeoplasie colorettaliStati Uniti, Hong Kong, Taiwan, Malaysia, Belgio, Cina, Israele, Olanda, Francia, Regno Unito, Messico, Tailandia, Italia, Spagna, Svezia, India, Germania, Brasile, Ungheria, Romania, Australia, Giappone, Polonia, Porto Rico, Corea... e altro ancora
-
Ohio State University Comprehensive Cancer CenterReclutamentoSindrome da resezione anteriore bassa | Carcinoma del rettoStati Uniti