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Validation Study for Robotic Surgery Simulator

8 juin 2017 mis à jour par: Atlantic Health System
A study to determine whether completing a rigorous simulation protocol could provide novice robotic surgeons with actual advanced surgical skills in an operating room setting.

Aperçu de l'étude

Statut

Complété

Description détaillée

Objective: To determine whether a group of surgeons otherwise naive to robotic techniques could demonstrate proficiency during their first robotic supracervical hysterectomy having only received simulator and pig lab training.

Primary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.

Secondary Outcome measures:

  1. Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
  2. Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
  3. Surgeon console biometrics- As measured by controller movements and grips
  4. Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.

Methods: To create the simulator protocol, 5 robotic surgeons (each averaging >75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices', and they performed each of these 10 modules to the best of their ability >5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.

We then recruited community board-certified OB-GYN's who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.

Two sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.

Type d'étude

Observationnel

Inscription (Réel)

14

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • New Jersey
      • Morristown, New Jersey, États-Unis, 07960
        • Morristown Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Gynecologic surgeons with no robotic experience

La description

Inclusion Criteria:

  • Must not have performed a da Vinci assisted surgery

Exclusion Criteria:

  • prior experience on the da Vinci system or the robotic simulator

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Expert Surgeons
Gynecologic robotic surgeons, each averaging >75 robotic cases per year
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
Study Surgeons
Gynecologic surgeons who are completely naive to robotics
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
Control Surgeons
Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Surgical Time
Délai: At end of cervical amputation
As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
At end of cervical amputation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Blood Loss
Délai: End of cervical amputation
As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume
End of cervical amputation
Surgical Skill Rating
Délai: Within a month of the performed surgery
All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet
Within a month of the performed surgery
Surgeon Console Biometrics
Délai: during surgery
As measured by controller movements and grip
during surgery
Novice Robotic Surgeon Data
Délai: Within a month of the performed surgery
Descriptive Operative data of surgeons who did not participate in robotic simulator training
Within a month of the performed surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Charbel Salamon, MD, Atlantic Health System

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2011

Achèvement primaire (Réel)

1 janvier 2012

Achèvement de l'étude (Réel)

1 janvier 2012

Dates d'inscription aux études

Première soumission

11 juin 2012

Première soumission répondant aux critères de contrôle qualité

12 juin 2012

Première publication (Estimation)

14 juin 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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