- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01618994
Validation Study for Robotic Surgery Simulator
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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:
- Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
- Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
- Surgeon console biometrics- As measured by controller movements and grips
- 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
-
Morristown, New Jersey, Forente stater, 07960
- Morristown Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Must not have performed a da Vinci assisted surgery
Exclusion Criteria:
- prior experience on the da Vinci system or the robotic simulator
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Surgical Time
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Loss
Tidsramme: 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
Tidsramme: 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
Tidsramme: during surgery
|
As measured by controller movements and grip
|
during surgery
|
|
Novice Robotic Surgeon Data
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Charbel Salamon, MD, Atlantic Health System
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R11-01-018
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