PowerPoint Presentation by pl0rfFN

VIEWS: 4 PAGES: 54

									 CHIRURGIA
 ROBOTICA

               G. Butturini
Department of Surgery, University of Verona, Italy
          ROBOTIC SURGERY

A surgical procedure or technology that adds computer
 technology-enhanced device to the interaction between a
 surgeon and a patient during a surgical operation and
 assumes some degree of control heretofore completely
 reserved to the surgeon.

The surgeon maintains control over the operation, indirectly and from
  an increased distance
           Tecnologia e chirurgia
   L’integrazione con l’imaging (segmentazione e virtual
    reality; ricostruzioni 3-D; navigatori i.o.)
   Le library informatizzate
   La precisione del movimento e l’esecuzione
    standardizzata di anastomosi
   L’automazione di procedure da semplici a complesse
   L’insegnamento e la simulazione di procedure
    complesse
   …tutto ciò in sicurezza per i pazienti e a basso costo!
Da Vinci
         Characteristics of DVSS
   Hand controls and pedals
   3-dimensional image
   The robotic arms follow the movements of the
    surgeon
   FDA only allows the use when the surgeon is in
    the same room
   Costs about 1 million USdollar (2 million news)
   Surgical instruments can be used max 10 times
            CLINICAL APPLICATIONS
PRIMARY CLINICAL ADVANTAGES

   Enhanced visualization (three-dimensional imaging
    of the operative field)
   Tremor reduction
   Improved ergonomics and fatigue reduction
   Multi-articulated instruments (full range of motion)
   Camera controlled by the surgeon
   Resident training
                    LIMITATIONS
   Lack of haptics
   Equipment size and weight
   Difficult team communication
   Costs (currently no robotic specific reimbursement)
   Prolonged operative time
   Single-quadrant application (problems with
    multiquadrant surgery)
   Alternating port position (requires disengagement
    of the robot)
      CONCLUSIONI REVIEW
   Fundoplicatio: continua a farla laparoscopica
   Heller Miotomy: col robot meno perforazioni
   Bypass gastrico: col robot più conversioni
   Gastrectomia: pochi dati per concludere q.sa
   Banding gastrico: col robot più lungo e costoso
   Colecistectomia: col robot interventi più lunghi
   Colectomie: col robot meno conversioni ma più
    lunghi e costosi
          CLINICAL APPLICATIONS
   Robotic surgery is feasible
   No studies exist yet to suggest that complication rates
    are higher than those of open or laparoscopic surgery
   Studies up to now have demonstrated increased costs
    and have failed to show clinical benefits
   There is a substantial cost disadvantage for simple
    procedures, such us cholecystectomy, but such
    procedures represent an excellent opportunity for
    increasing acquisition of more advanced skills for
    surgeons early in their robotic learning curve!
          Robotic Technology

 Additional variable cost using robot-
  assisted procedure is ~13%
 Short term benefit derives from the
  laparoscopic approach
 No improvement of patient outcomes or
  quality of life in the long run
 Contribution to the substitution of surgical
  for non surgical treatments

[from The New England Journal of Medicine, August 2010 ]
    Implementare la chirurgia robotica
   Studi clinici controllati (es. Emilia Romagna con
    un confronto fra colectomia VLS e robotica
    prima di acquisire nuovi device)
   Programmi interdipartimentali (Università di
    Pisa) Incrementare l’utilizzo delle macchine
    esistenti
   Studi pilota su grande chirurgia (DCP
    epatectomie, valutare le complicanze)
   Sviluppi di nuova tecnologia robotica
        ROBOTICS:
   Universal utilisation of
 Minimally Invasive Surgery
75%+ of procedures         Applicable to any
still limited to radical   Laparosopic procedure
prostatectomy
        Materials and Methods
  A new concept of robotic device was designed
  taking origin from laparoscopic technique to
  enhance it. A console was developed to provide
  intuitive manoeuvres for laparoscopic expert
  surgeons. At the slave side robots carry commercial
  or ad hoc laparoscopic instruments.
After laboratory tests, a surgical procedure on animal
  was performed. The pig was chosen because of its
  anatomical characteristics and dimensions, very
  near to the human body; two pigs of 70/90 Kg
  were operated with the intent to perform a spleen
  preserving distal pancreatectomy with a five trocars
  technique.
   SURGENIUS – a complete and
        flexible system

 2 Masters

 Any # of
  Robotic
  Arms
  A new surgical robot prototype
SENSITIVE        Force-feedback and movement scaling
                 9 degrees of freedom

FLEXIBLE         Modular design: easy and fast to set-up,
                 multi-quadrant procedures allowed.
                 Can execute both laparoscopic and open
                 procedures with microsurgery precision

COMPACT          Very compact and light; can be transported
                 to another OR in a few minutes,
                 increasing the number of operations per day

COST-EFFECTIVE   Reduced Cost of Ownership
                  Results


A surgical robot prototype was realized to
verify the hypothesis. The two laboratory
tests have shown that the innovative setup
is intuitive and it has good robotic features:
tremor filtering, ergonomic, safety,
movements scaling, adequate degrees of
freedom
                   Conclusions
A new concept of robotic device is under investigation to
take advantage of the robotic technology in complex
surgical procedure.
    Which factors threaten the patients’
                safety?.....

 Primary disease
 Diagnostic error

 Therapeutic course:

     - Preparing for surgery
     - At the O.R
     - Post-operative course
    And where can new technologies
               help?.....

 Primary disease
 Diagnostic error

 Therapeutic course:

     - Preparing for surgery
     - At the O.R
     - Post-operative course
       CLINICAL ENVIROMENT

   All personnel in the O.R must be
    appropriately trained to handle this
    equipment

   Currently, no standard criteria are set forth for
    registered nurses, O.R technicians, or
    surgeons
        MEDICAL
        ERRORS
   2,000 deaths/year from unnecessary surgery;
   7000 deaths/year from medication errors in hospitals;
   20,000 deaths/year from other errors in hospitals; 80,000 deaths/year
    from infections in hospitals;
   106,000 deaths/year from non-error, adverse effects of medications
   Total of 225,000 deaths/year in the US from iatrogenic causes (# 3
    killer).
    Even using the lower estimate, more people die from medical mistakes
    each year than from highway accidents, breast cancer, or AIDS.




                                     The JOURNAL of the AMERICAN MEDICAL ASSOCIATION
                                     (JAMA) Vol 284, No 4, July 26th 2000
                          Surgical Safety Checklist
At the O.R:

Before induction of anaesthesia: Before skin incision:                     Before the patient leaves
                                                                              the O.R:
   Patient must confirm: identity,    •Confirm all team members have
    site, procedure, consent           introduced themselves by name          Nurse verbally confirms
                                       and role                                with the team: the name
   Anaesthesia safety check                                                   of the procedure
    completed                          •Surgeon, anaesthesia
                                       professional and nurse verbally         recorded; the instrument,
   Pulse oximeter on patient and                                              sponge and needle counts
                                       confirm: patient, site, procedure
    functioning                                                                are correct; how the
                                       •Anticipated critical events:
   Controll if patient has or not a                                           specimen is labelled;
                                       surgeon reviews what are the            whether there are any
    known allergy
                                       critical or unexpected steps,           equipment problems to
   Difficult airway/aspiration risk   operative duration, anticipated
    (if yes: equipment/assistance                                              be addressed
                                       blood loss; anaesthesia team            Surgeon, anaesthesia
    must be available)                                                     
                                       reviews if there are any patient-       professional and nurse
   Risk of > 500 ml blood loss (if    specific concerns; nursing team
    yes: adeguate intravenous                                                  review the key concerns
                                       reviews if sterility has been           for recovery and
    access and fluids planned).
    There is always such risk in       confirmed and if there are any          management of this
    pancreatic surgery.                equipment issues or concerns            patient
                                       •Controll if adeguate antibiotic
                                       prophylaxis has been given within
                                       the last 60 minutes
                                       •Controll if essential imaging is
                                       displayed
                                                                                World Health Organization
         O.R INTEGRATION


Integrated computerized tracking of surgical
 activity, work flow, and use of materials,
 devices and consumables could enhance
 task performance, quality of care and
 patient safety
•Surgical complications are common and often
preventable

• The checklist was designed to improve team
communication and consistency of care

• The implementation of the checklist was able to
reduce global mortality rate from 1,5% to 0.8%
and inpatient complications from 11% to 7%.

A surgical safety checklist alone can reduce
morbidity and mortality in a global population!
             Give the surgeon a hand….

 Integration of radiological imaging
 Development of high integrity medical device systems:
 - develop systems for tactile sensation
 - reduce equipment size and weight
 Encourage hospital administration and nursing management
  to stand behind the robotics program
 Develop an operative scheduling routine
 Gather a dedicated team in the O.R to work with frequently
 Record the data for every case
 Visit colleagues, attend international meetings and follow
  current literature
    And last, but not least...
                    TRAINING

   Ensure that surgeons are adequately trained in
    the use of the surgical robot before applying
    them to the clinical setting

   The surgeon must have both a knowledge base and
    a practical working familiarity with these complex
    devices before clinical use
                 TRAINING

The surgeon must have the judgment and training for
 safe completion of the procedure as intended, as well
 as the capability of immediately proceeding to an
 alternative therapy when the circumstances so
 indicate.
             WHO SHOULD BE
               TRAINED?
1.   Fully trained laparoscopic surgeon add
     specific knowledge of robotic technology to an
     existing set of skills
2.   Surgeon who chooses to begin his minimally
     invasive endeavors using the robot
     guidelines for privileging qualified surgeons in
     the performance of surgical procedures using
     therapeutic robotic surgical devices alone or in
     an hybrid fashion
       GUIDELINES for INSTITUTIONS GRANTING
       PRIVILEGES in THERAPEUTIC ROBOTIC
       PROCEDURES


   SURGICAL PROFICIENCY for every surgeon, using
    universally applicable criteria (responsability of the surgical
    department)
   DOCUMENTED TRAINING AND EXPERIENCE:
    - CASE LIST specifying the applicant’s role; complications,
    outcomes, conversion to traditional technique
    - SUMMARY LETTER from the chief of service that states
    whether the applicant can independently and competently
    perform the procedure
   FORMAL COURSE:
    - Taught by instructors with appropriate clinical experience
    - Curricilum including didactic instruction AND
    - hands-on experience using inanimate and/or animate models
    - Written assesment of the partecipant’s mastery of course
    objectives
    - Verification of attendance
                       MINIMUM REQUIREMENTS
                          for granting privileges
      FORMAL SPECIALTY TRAINING: satisfactory completion of an accredited
       surgical residency program (mandatory)
      FORMAL TRAINING IN RESIDENCY AND/OR FELLOWSHIP
       PROGRAMS: for surgeons that already have a structured curriculum in minimal access
       procedures and therapeutic robotic devices and their use
      NO FORMAL RESIDENCY TRAINING IN THERAPEUTIC ROBOTIC
       SURGERY: the curriculum should be defined by the institution and should include
       didactic education and an educational program
      PRACTICAL EXPERIENCE:
1.    Applicant’s experience: appropriate volume of cases with satisfactory outcome
2.    Initial clinical experience with the specific procedure: adequate number of cases to allow proficient
      completion of the procedure
3.    Criteria of competency for each procedure:
     - established in advance, by the chief of service
     - evaluation of familiarity with instrumentation and equipment, competency in thei use,
      appropriateness of patient selection, clarity of dissection, safety, successful completion of
      the procedure
     FORMAL ASSESSMENT OF COMPETENCY: certificates of completion of
      training
           MAINTENANCE OF PRIVILEGES



   PROVISIONAL PRIVILEGES
   MONITORING OF PERFORMANCE
   CONTINUING MEDICAL EDUCATION
   RENEWAL (continuing clinical activity, review of quality
    assurance data, continuing medical education activity)

   DENIAL OF PRIVILEGES
        GUIDELINES for TRAINING
PURPOSE
     COURSE providing:
   SKILL TRAINING
   FAMILIARIZATION WITH THE
    TECHNOLOGY


AS PREPARATION FOR THE PERFORMANCE
 OF A MENTORED CLINICAL EXPERIENCE
       GUIDELINES for TRAINING
EXPERT INSTRUCTOR
 Substantial practical experience
 Use of this technology in clinical
  applications
 Reported results and reviews

 Specialty-specific experience

 Expertise in advanced technology
                GUIDELINES for TRAINING
DIDACTICS
   Complete understanding of the technology, device function, altered
    functional status, basic troubleshooting, device parameters and
    limitations
   PROCEDURE-SPECIFIC INFORMATION: indications, workup
    patient selection, instrumentation, preoperative preparation, patient
    and system positioning, port placement, procedural steps,
    complications, management
   LEARNING CURVE-RELATED ISSUES: report outcomes
   The length of the educational experience should reflect the complexity
    of the technology, the specialty-specific procedure and the underlying students’
    experience
         GUIDELINES for TRAINING

LIVE CASE OBSERVATION
   PROCEDURE PREPARATION

   SYSTEM SETUP

   PATIENT POSITIONING

   REVIEW OF CASE SELECTION INTRAOPERATIVE
    TECHNICAL ASPECTS
            GUIDELINES for TRAINING

HANDS-ON EXPERIENCE
   NONCLINICAL SIMULATION: system setup, connections,
    operation and troubleshooting

   PROCEDURE SPECIFIC MODELING with successful
    completion of the key components, using an appropriate model

   ADNVANCED SIMULATION TOOLS
     GUIDELINES for TRAINING

RESIDENCY PROGRAMS

EXPOSURE TO THERAPEUTIC ROBOTIC
  INTERVENTIONS and STRUCTURED
CURRICULUM included in programs providing
            clinical experience
        SURGICAL SIMULATORS

   Currently, no simulators exist that provide
    training equivalent to that obtained by clinical
    practice
               IN THE FUTURE…..
   ’’Smart instruments’’: ’’smart sensing’’ capabilities (information
    about tissue oxygenation, blood flow, molecular information,
    tumor margin information!)
   Enhanced operator vision: anatomic overlays, help screens, ’’optical
    biopsy’’ (confocal microscopy, optical coherent tomography),
    computer-assisted visualization, real time microscopy, molecular
    imaging
   Integration of anatomic and physiologic data into the operative field: pre-
    operative and intra-operative imaging registered with the surgical
    device and fused with the visual field
   Virtual barriers: identification of dangerous anatomic areas;
    information used to guide surgical procedures intraoperatively
    and/or simulate a proposed procedure before it is preformed
DOCUMENTATION OF OUTCOMES

   Outcomes registries for robotic surgery will be essential
    in order to :
-   carry out accurate comparisons between robotic
    surgery and traditional approaches
-   document quality of outcomes
-   Identify new directions for development

								
To top