- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02565875
Standardizing Language in Laparoscopic Surgery (SLL)
Does Standardizing Language in Laparoscopic Surgery Improve Efficiency? A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- University of Ottawa Skills and Simulation Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Obstetrics and Gynecology Residents OR fellows OR attending physicians
Exclusion Criteria:
- Physical disability preventing the candidate from performing laparoscopic surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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Comparateur 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Procedure Time
Délai: Recorded once per simulated laparoscopic task upon completion (one visit)
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The simulated laparoscopic task will be timed from initiation to completion
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Recorded once per simulated laparoscopic task upon completion (one visit)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Communication
Délai: Recorded during per simulated laparoscopic task (one visit)
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Tabulated instances of the use of SLL during simulated laparoscopic task from initiation to completion
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Recorded during per simulated laparoscopic task (one visit)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Post-Intervention Survey
Délai: After completion of simulated laparoscopic task (one visit)
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Survey requesting qualitative data on experience and the effect of presentations on anxiety during simulated task
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After completion of simulated laparoscopic task (one visit)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Glenn D Posner, MDCM, FRCSC, Medical Director of the University of Ottawa Skills and Simulation Centre
Publications et liens utiles
Publications générales
- Mehdizadeh, Mehra, et al. Standardizing Language in Laparoscopy: A Modified Delphi Approach. (Poster) AIME Day, The University of Ottawa, Canada
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 20150727-01H
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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