<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274050</url>
  </required_header>
  <id_info>
    <org_study_id>NI16026J</org_study_id>
    <secondary_id>2017-A01507-46</secondary_id>
    <nct_id>NCT03274050</nct_id>
  </id_info>
  <brief_title>To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults</brief_title>
  <acronym>PECRoP</acronym>
  <official_title>To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical&#xD;
      procedures in adult patients across a broad spectrum of surgical specialties. This has&#xD;
      occurred despite the high costs and uncertain benefits of surgical robots.&#xD;
&#xD;
      In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to&#xD;
      embrace the surgical robot. Many children's hospitals do not even possess a surgical robot,&#xD;
      and many of those that do borrow them from the adult operating room within the same medical&#xD;
      facility.&#xD;
&#xD;
      Since the first case of robotic minimally invasive surgery in children in 2000, robotic&#xD;
      procedures have been slowly adopted by select pediatric surgical specialists.&#xD;
&#xD;
      Advocates of robotic minimally invasive surgical systems add many useful features that&#xD;
      include improved dexterity, motion scaling, tremor filtration, greater optical magnification&#xD;
      (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of&#xD;
      the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic&#xD;
      instruments used in robotic surgery provide seven degrees of freedom.&#xD;
&#xD;
      For the surgeon, these features may allow for more precise dissection with increased&#xD;
      magnification and visibility. The intuitive controls of the robot are purported as providing&#xD;
      the ability to perform laparoscopic procedures in an &quot;open&quot; fashion. In pediatric surgical&#xD;
      procedures, these technical abilities may have the potential to surpass the physical&#xD;
      capabilities of human performance in the tight operative fields encountered in children.&#xD;
&#xD;
      This study aims to evaluate the clinical safety and efficiency in a dedicated&#xD;
      multidisciplinary pediatric program and to evaluate the relative cost of robotic surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopy has been adopted for advantages that include decreased adhesion formation,&#xD;
      improved cosmesis, decreased post-operative pain, and shorter recovery times.&#xD;
&#xD;
      The patient benefits of robotic surgery are thought to be essentially the same as&#xD;
      conventional laparoscopy: decreased length of stay, decreased blood loss, decreased pain,&#xD;
      quicker return to work, and improved cosmetic result through smaller incisions. In pediatric&#xD;
      urology, there is evidence that robot-assisted pyeloplasty may be superior to open and&#xD;
      laparoscopic approach with decreased length of stay, decreased narcotic use, and decreased&#xD;
      operative times.&#xD;
&#xD;
      The overall reported conversion-to-open-procedure rate is low, comparable to the conversion&#xD;
      rate in conventional pediatric minimally invasive surgery.&#xD;
&#xD;
      Robotic surgical technology may have a role in pediatric minimal access surgery. Design&#xD;
      features of robotic surgical platforms include motion scaling, greater optical magnification,&#xD;
      stereoscopic vision, increased instrument tip dexterity, tremor filtration, instrument&#xD;
      indexing, operator controlled camera movement, and elimination of the fulcrum effect. These&#xD;
      robotic enhancements offer improvements to conventional minimal access surgery, permitting&#xD;
      technical capabilities beyond existing threshold limits of human performance for surgery&#xD;
      within the spatially constrained operative workspaces in children. There is evidence that a&#xD;
      learning curve is encountered when adopting robotic surgery as demonstrated by decreasing&#xD;
      operative times as case volumes increased&#xD;
&#xD;
      At a stand-alone pediatric hospital, a robotic platform is often not available. Only a&#xD;
      minority of pediatric hospitals have robotic systems given the limited number of procedures&#xD;
      performed nationally. This is probably due to the costs of acquiring and maintaining a&#xD;
      surgical robot coupled with the tendency for pediatric hospitals to have less income and&#xD;
      fewer eligible patients to defray the fixed costs of the platform. A unique situation exists&#xD;
      for pediatric surgeons in hospitals affiliated with adult care as robots may be available&#xD;
      that are primarily used for adult subspecialties, most often urology. In this setup, the&#xD;
      logistics may be difficult and the pediatric team must be flexible and mobile to accommodate&#xD;
      the robot.&#xD;
&#xD;
      Robotic surgery has higher costs than open and laparoscopic procedures. This is due to the&#xD;
      high costs of purchasing and maintaining a robot, increased operative time, and costs of&#xD;
      disposable surgical supplies.&#xD;
&#xD;
      The specificity of this study is to evaluate the clinical safety and efficiency in a&#xD;
      dedicated multidisciplinary pediatric program (gastrointestinal surgery, genitourinary&#xD;
      surgery, thoracic surgery, ENT, cardiac surgery and microsurgery) and to evaluate the&#xD;
      relative cost of robotic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 28, 2018</start_date>
  <completion_date type="Anticipated">August 2029</completion_date>
  <primary_completion_date type="Anticipated">August 2029</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Per and post-surgery complication</measure>
    <time_frame>6 months</time_frame>
    <description>per and post-surgery complication (Clavien-Dindo score)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-surgery pain with analgesic prescription</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection quality (R0) of oncologic surgery</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional results according to the surgery indication</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>6 months</time_frame>
    <description>36-items Short Form health survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health survey (EQ-5D-5L)</measure>
    <time_frame>6 months</time_frame>
    <description>Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Saint-George's hospital Respiratory Questionnaire (SGRQ)</measure>
    <time_frame>6 months</time_frame>
    <description>0 indicates best health and 100 indicates worst health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Improvement (PGI-I)</measure>
    <time_frame>6 months</time_frame>
    <description>1-question assessment designed to evaluate the patient's impression of improvement since surgery- PGI-I score: 1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 6 = much worse; 7 = very much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and percentage of intervention with robot in each speciality</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of activity of the operating block</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average duration of anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average duration of robotic surgery and docking</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of intervention by speciality (learning curve)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and percentage of conversion to open-procedure</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post surgery pain (Evendol pain scale)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescription of analgesic</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of robotic surgery by indication, tools and supplies</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of post surgery work stoppage (activ patient)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration before returning to normal activity (other patient)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in average costs per patients (in €) divided by the difference in post operative complications using the Clavien Dindo scale</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">16000</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>patient group</arm_group_label>
    <description>Surgery with robot - all patients operated in surgery department with indication of robot in the routine care (all specialities).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>Retroperitoneal coelioscopy - patient operated for pyeloplasty - only for pediatry</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        all patients operated in surgery department participating of the study with indication of&#xD;
        robot in the routine care (all specialities)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria :&#xD;
&#xD;
          -  child or adult&#xD;
&#xD;
          -  with an indication for a robotic surgery&#xD;
&#xD;
          -  non-opposition of patient or non-opposition of parents for minor patient&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  anatomic or anesthetic contraindication for the mini-invasive surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas BLANC, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Morgane ROUPRET, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas BLANC, MD, PhD</last_name>
    <phone>01 44 49 41 53</phone>
    <email>thomas.blanc@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Solimda SOTOU BERE</last_name>
    <phone>01 42 19 28 79</phone>
    <email>solimda.sotoubere@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Necker -Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Blanc, MD, PhD</last_name>
      <phone>01 44 49 41 53</phone>
      <email>thomas.blanc@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>robot</keyword>
  <keyword>surgery</keyword>
  <keyword>pediatry (0-20 years included)</keyword>
  <keyword>adults</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274050
org study id: NI16026J
secondary id: 2017-A01507-46
nct id: NCT03274050
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical
      procedures in adult patients across a broad spectrum of surgical specialties. This has
      occurred despite the high costs and uncertain benefits of surgical robots.

      In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to
      embrace the surgical robot. Many children's hospitals do not even possess a surgical robot,
      and many of those that do borrow them from the adult operating room within the same medical
      facility.

      Since the first case of robotic minimally invasive surgery in children in 2000, robotic
      procedures have been slowly adopted by select pediatric surgical specialists.

      Advocates of robotic minimally invasive surgical systems add many useful features that
      include improved dexterity, motion scaling, tremor filtration, greater optical magnification
      (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of
      the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic
      instruments used in robotic surgery provide seven degrees of freedom.

      For the surgeon, these features may allow for more precise dissection with increased
      magnification and visibility. The intuitive controls of the robot are purported as providing
      the ability to perform laparoscopic procedures in an "open" fashion. In pediatric surgical
      procedures, these technical abilities may have the potential to surpass the physical
      capabilities of human performance in the tight operative fields encountered in children.

      This study aims to evaluate the clinical safety and efficiency in a dedicated
      multidisciplinary pediatric program and to evaluate the relative cost of robotic surgery
Laparoscopy has been adopted for advantages that include decreased adhesion formation,
      improved cosmesis, decreased post-operative pain, and shorter recovery times.

      The patient benefits of robotic surgery are thought to be essentially the same as
      conventional laparoscopy: decreased length of stay, decreased blood loss, decreased pain,
      quicker return to work, and improved cosmetic result through smaller incisions. In pediatric
      urology, there is evidence that robot-assisted pyeloplasty may be superior to open and
      laparoscopic approach with decreased length of stay, decreased narcotic use, and decreased
      operative times.

      The overall reported conversion-to-open-procedure rate is low, comparable to the conversion
      rate in conventional pediatric minimally invasive surgery.

      Robotic surgical technology may have a role in pediatric minimal access surgery. Design
      features of robotic surgical platforms include motion scaling, greater optical magnification,
      stereoscopic vision, increased instrument tip dexterity, tremor filtration, instrument
      indexing, operator controlled camera movement, and elimination of the fulcrum effect. These
      robotic enhancements offer improvements to conventional minimal access surgery, permitting
      technical capabilities beyond existing threshold limits of human performance for surgery
      within the spatially constrained operative workspaces in children. There is evidence that a
      learning curve is encountered when adopting robotic surgery as demonstrated by decreasing
      operative times as case volumes increased

      At a stand-alone pediatric hospital, a robotic platform is often not available. Only a
      minority of pediatric hospitals have robotic systems given the limited number of procedures
      performed nationally. This is probably due to the costs of acquiring and maintaining a
      surgical robot coupled with the tendency for pediatric hospitals to have less income and
      fewer eligible patients to defray the fixed costs of the platform. A unique situation exists
      for pediatric surgeons in hospitals affiliated with adult care as robots may be available
      that are primarily used for adult subspecialties, most often urology. In this setup, the
      logistics may be difficult and the pediatric team must be flexible and mobile to accommodate
      the robot.

      Robotic surgery has higher costs than open and laparoscopic procedures. This is due to the
      high costs of purchasing and maintaining a robot, increased operative time, and costs of
      disposable surgical supplies.

      The specificity of this study is to evaluate the clinical safety and efficiency in a
      dedicated multidisciplinary pediatric program (gastrointestinal surgery, genitourinary
      surgery, thoracic surgery, ENT, cardiac surgery and microsurgery) and to evaluate the
      relative cost of robotic surgery.
observational model: Case-Control
time perspective: Other
measure: Per and post-surgery complication
time frame: 6 months
description: per and post-surgery complication (Clavien-Dindo score)
measure: Post-surgery pain with analgesic prescription
time frame: 6 months
measure: Resection quality (R0) of oncologic surgery
time frame: 6 months
measure: Functional results according to the surgery indication
time frame: 6 months
measure: Quality of life (SF-36)
time frame: 6 months
description: 36-items Short Form health survey
measure: Health survey (EQ-5D-5L)
time frame: 6 months
description: Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5)
measure: The Saint-George's hospital Respiratory Questionnaire (SGRQ)
time frame: 6 months
description: 0 indicates best health and 100 indicates worst health
measure: Patient Global Impression of Improvement (PGI-I)
time frame: 6 months
description: 1-question assessment designed to evaluate the patient's impression of improvement since surgery- PGI-I score: 1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 6 = much worse; 7 = very much worse
measure: Frequency and percentage of intervention with robot in each speciality
time frame: 6 months
measure: Duration of activity of the operating block
time frame: 6 months
measure: Average duration of anaesthesia
time frame: 6 months
measure: Average duration of robotic surgery and docking
time frame: 6 months
measure: Duration of intervention by speciality (learning curve)
time frame: 6 months
measure: Frequency and percentage of conversion to open-procedure
time frame: 6 months
measure: Post surgery pain (Evendol pain scale)
time frame: 6 months
measure: Prescription of analgesic
time frame: 6 months
measure: Duration of hospitalization
time frame: 6 months
measure: Cost of robotic surgery by indication, tools and supplies
time frame: 6 months
measure: Duration of post surgery work stoppage (activ patient)
time frame: 6 months
measure: Duration before returning to normal activity (other patient)
time frame: 6 months
measure: Difference in average costs per patients (in €) divided by the difference in post operative complications using the Clavien Dindo scale
time frame: 6 months
arm group label: patient group
description: Surgery with robot - all patients operated in surgery department with indication of robot in the routine care (all specialities).
arm group label: control group
description: Retroperitoneal coelioscopy - patient operated for pyeloplasty - only for pediatry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas BLANC, MD; PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Morgane ROUPRET, MD, PhD
role: Study Chair
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Thomas BLANC, MD, PhD
phone: 01 44 49 41 53
email: thomas.blanc@aphp.fr
last name: Solimda SOTOU BERE
phone: 01 42 19 28 79
email: solimda.sotoubere@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No