Pelvic Organ ProlapseNCT01618994
Validation Study for Robotic Surgery Simulator
An observational study of Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Performing robotic supracervical hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Gynecologic surgeons with no robotic experience
Who may be able to join
- Must not have performed a da Vinci assisted surgery
Who cannot join
- prior experience on the da Vinci system or the robotic simulator
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Medical Center
Morristown, New Jersey, 07960
About this study
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.
Read the detailed description
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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Performing robotic supracervical hysterectomy
- Keywords
- Robotic Simulator, EBL, Robotic Surgeons, Intuitive Surgical, simulation modules, benchmarks, Morristown Protocol, Study Surgeons, Control Surgeons, Expert Surgeons, dual-console daVinci system, blinded skill assessment
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing robotic supracervical hysterectomyProcedure or surgery
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Expert Surgeons | Gynecologic robotic surgeons, each averaging >75 robotic cases per year Receives: Procedure: Performing robotic supracervical hysterectomy | |
| Study Surgeons | Gynecologic surgeons who are completely naive to robotics Receives: Procedure: Performing 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 Receives: Procedure: Performing robotic supracervical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Time
As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
Measured: At end of cervical amputation
Secondary outcomes (4)
Blood Loss
As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume
Measured: End of cervical amputation
Surgical Skill Rating
All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet
Measured: Within a month of the performed surgery
Surgeon Console Biometrics
As measured by controller movements and grip
Measured: during surgery
Novice Robotic Surgeon Data
Descriptive Operative data of surgeons who did not participate in robotic simulator training
Measured: Within a month of the performed surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Patrick Culligan, MD, Principal investigator, Atlantic Health SystemCharbel Salamon, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618994
- Sponsor's protocol ID
- R11-01-018
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2012
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study for Robotic Surgery Simulator
- ClinicalTrials.gov ID
- NCT01618994
- Acronym / sponsor ID
- R11-01-018
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Robotic Simulator, EBL, Robotic Surgeons, Intuitive Surgical, simulation modules, benchmarks, Morristown Protocol, Study Surgeons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expert Surgeons | – | Procedure: Performing robotic supracervical hysterectomyGynecologic robotic surgeons, each averaging >75 robotic cases per year |
| Study Surgeons | – | Procedure: Performing robotic supracervical hysterectomyGynecologic surgeons who are completely naive to robotics |
| Control Surgeons | – | Procedure: Performing robotic supracervical hysterectomyGynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Gynecologic surgeons with no robotic experience
Key inclusion criteria (1 listed)
- Must not have performed a da Vinci assisted surgery
Key exclusion criteria (1 listed)
- prior experience on the da Vinci system or the robotic simulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performing robotic supracervical hysterectomyAll groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy | Procedure or surgery | Control Surgeons, Expert Surgeons, Study Surgeons |
Primary outcome
Surgical Time
Time frame: At end of cervical amputation
As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
4 secondary outcomes
Blood Loss
Time frame: End of cervical amputation
Surgical Skill Rating
Time frame: Within a month of the performed surgery
Surgeon Console Biometrics
Time frame: during surgery
Novice Robotic Surgeon Data
Time frame: Within a month of the performed surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Related trials for Pelvic Organ Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Culligan, MD principal investigator
Atlantic Health System
Charbel Salamon, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Time (time frame: At end of cervical amputation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.