<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/NCT03019016</url>
  </required_header>
  <id_info>
    <org_study_id>ISI-dVRC-001</org_study_id>
    <nct_id>NCT03019016</nct_id>
  </id_info>
  <brief_title>Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy</brief_title>
  <official_title>A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuitive Surgical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to retrospectively compare the perioperative and&#xD;
      short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal&#xD;
      anastomosis in minimally invasive right colectomies for benign and malignant disease.&#xD;
&#xD;
      The secondary objective of this study is to retrospectively compare the rates of incisional&#xD;
      hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, retrospective chart review study of all consecutive cases of right&#xD;
      colectomy performed by participating surgeons at their respective institutions that meet all&#xD;
      inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal&#xD;
      or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study&#xD;
      inclusion and exclusion criteria, will be considered for inclusion. The chart review will be&#xD;
      performed in a reverse chronological order starting at a minimum of 30 days prior to IRB&#xD;
      approval of the study at the site until the number of robotic-assisted and laparoscopic cases&#xD;
      to be included per surgeon has been met. Study initiation at the participating site will&#xD;
      occur once a research agreement has been executed between Intuitive Surgical and the&#xD;
      participating Institution/Investigator and IRB approval has been obtained.&#xD;
&#xD;
      It is anticipated that the retrospective chart review will span the period between January 1,&#xD;
      2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient&#xD;
      characteristics, perioperative and post-operative short term clinical and pathological&#xD;
      outcomes, and incisional hernia data will be obtained from hospital records for a total of up&#xD;
      to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted&#xD;
      right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy&#xD;
      with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal&#xD;
      anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA).&#xD;
      Since the data will have been de-identified, and is archival in nature, there will be no&#xD;
      active subject recruitment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Chart review on PeriOperative Information</measure>
    <time_frame>Intraoperative through 30-days follow-up</time_frame>
    <description>Number of complications observed intraoperatively through 30-days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chart review on Postoperative Information</measure>
    <time_frame>Postoperative through 6 month follow-up</time_frame>
    <description>Number of complications observed postoperatively through 6 month</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Colonic Neoplasms</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Robotic RC (IA)</arm_group_label>
    <description>Benign or malignant disease under going a right colectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic RC (EA)</arm_group_label>
    <description>Patients with benign or malignant disease under going a right colectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic RC (IA)</arm_group_label>
    <description>Patients with benign or malignant disease under going a right colectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic RC (EA)</arm_group_label>
    <description>Patients with benign or malignant disease under going a right colectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Right Colectomy</intervention_name>
    <description>Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.</description>
    <arm_group_label>Laparoscopic RC (EA)</arm_group_label>
    <arm_group_label>Laparoscopic RC (IA)</arm_group_label>
    <arm_group_label>Robotic RC (EA)</arm_group_label>
    <arm_group_label>Robotic RC (IA)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Age ≥ 18 years Patients with benign or malignant right colon disease Patients who have&#xD;
        undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or&#xD;
        extracorporeal anastomosis either on or proximal to mid-transverse colon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patients with benign or malignant right colon disease&#xD;
&#xD;
          -  Patients who have undergone robotic-assisted or laparoscopic right colectomy with&#xD;
             intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse&#xD;
             colon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with perforated, obstructing or locally invasive neoplasm (T4b)&#xD;
&#xD;
          -  Emergency procedures&#xD;
&#xD;
          -  Patients undergoing right colectomy as a secondary procedure&#xD;
&#xD;
          -  Patients undergoing radiation therapy for malignant neoplasia before and after&#xD;
             procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shilpa Mehendale</last_name>
    <role>Study Director</role>
    <affiliation>Sr Director, Clinical Affairs, Intuitive Surgical, Inc.</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03019016
org study id: ISI-dVRC-001
nct id: NCT03019016
lead sponsor: 
has dmc: No
The primary objective of this study is to retrospectively compare the perioperative and
      short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal
      anastomosis in minimally invasive right colectomies for benign and malignant disease.

      The secondary objective of this study is to retrospectively compare the rates of incisional
      hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.
This is a multi-center, retrospective chart review study of all consecutive cases of right
      colectomy performed by participating surgeons at their respective institutions that meet all
      inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal
      or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study
      inclusion and exclusion criteria, will be considered for inclusion. The chart review will be
      performed in a reverse chronological order starting at a minimum of 30 days prior to IRB
      approval of the study at the site until the number of robotic-assisted and laparoscopic cases
      to be included per surgeon has been met. Study initiation at the participating site will
      occur once a research agreement has been executed between Intuitive Surgical and the
      participating Institution/Investigator and IRB approval has been obtained.

      It is anticipated that the retrospective chart review will span the period between January 1,
      2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient
      characteristics, perioperative and post-operative short term clinical and pathological
      outcomes, and incisional hernia data will be obtained from hospital records for a total of up
      to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted
      right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy
      with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal
      anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA).
      Since the data will have been de-identified, and is archival in nature, there will be no
      active subject recruitment.
observational model: Cohort
time perspective: Retrospective
measure: Chart review on PeriOperative Information
time frame: Intraoperative through 30-days follow-up
description: Number of complications observed intraoperatively through 30-days
measure: Chart review on Postoperative Information
time frame: Postoperative through 6 month follow-up
description: Number of complications observed postoperatively through 6 month
arm group label: Robotic RC (IA)
description: Benign or malignant disease under going a right colectomy.
arm group label: Robotic RC (EA)
description: Patients with benign or malignant disease under going a right colectomy.
arm group label: Laparoscopic RC (IA)
description: Patients with benign or malignant disease under going a right colectomy.
arm group label: Laparoscopic RC (EA)
description: Patients with benign or malignant disease under going a right colectomy.
intervention type: Procedure
intervention name: Right Colectomy
description: Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
arm group label: Laparoscopic RC (EA)
arm group label: Laparoscopic RC (IA)
arm group label: Robotic RC (EA)
arm group label: Robotic RC (IA)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shilpa Mehendale
role: Study Director
affiliation: Sr Director, Clinical Affairs, Intuitive Surgical, Inc.
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Crohn Disease
sharing ipd: Yes