<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/NCT03007758</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00062464</org_study_id>
    <nct_id>NCT03007758</nct_id>
  </id_info>
  <brief_title>Open Versus Robotic Retromuscular Ventral Hernia Repair</brief_title>
  <acronym>ORREO</acronym>
  <official_title>Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prisma Health-Upstate</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prisma Health-Upstate</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how the robotic retromuscular hernia repair&#xD;
      compares to the open retromuscular hernia repair for large hernia defects in patients at&#xD;
      higher risk of wound complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients presenting to the Greenville Health System Hernia Center who meet the inclusion&#xD;
      criteria will be considered for enrollment. Patients who qualify and agree to participate&#xD;
      will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular&#xD;
      ventral hernia repair. Data to be collected includes the following: demographic information,&#xD;
      medical characteristics, medications, medical and surgical history, operative details,&#xD;
      hospital stay data, and patient-reported outcomes via a quality of life questionnaire.&#xD;
      Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All surgical site occurrences</measure>
    <time_frame>Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site occurrences requiring procedural intervention</measure>
    <time_frame>Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All surgical site infections</measure>
    <time_frame>Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infections requiring procedural intervention</measure>
    <time_frame>Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay at hospital measured in days</measure>
    <time_frame>Time from procedure until discharge, an expected range of 2 to10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time (procedure start to procedure finish measured in minutes)</measure>
    <time_frame>Day of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life via questionnaire</measure>
    <time_frame>Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost for hospital charges from billing office</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>robotic ventral hernia repair (VHR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Robotic VHR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open ventral hernia repair (VHR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open VHR</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open ventral hernia repair</intervention_name>
    <description>An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia.</description>
    <arm_group_label>open ventral hernia repair (VHR)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>robotic ventral hernia repair</intervention_name>
    <description>A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip.</description>
    <arm_group_label>robotic ventral hernia repair (VHR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm.&#xD;
&#xD;
          -  At least one of the following risk factors: Body Mass Index &gt; 30, Chronic Obstructive&#xD;
             Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current abdominal wall infection&#xD;
&#xD;
          -  Presence of ileostomy, colostomy, or ileal conduit&#xD;
&#xD;
          -  Center for Disease Control wound class 3 or 4&#xD;
&#xD;
          -  Hernia defect &lt; 7 cm or &gt;15 cm&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy A Warren, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prisma Health-Upstate</affiliation>
  </overall_official>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hernia repair</keyword>
  <keyword>Robotic hernia repair</keyword>
  <keyword>Open hernia repair</keyword>
  <keyword>Incisional hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.</ipd_description>
  </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/NCT03007758
org study id: Pro00062464
nct id: NCT03007758
lead sponsor: 
has dmc: No
The purpose of this study is to determine how the robotic retromuscular hernia repair
      compares to the open retromuscular hernia repair for large hernia defects in patients at
      higher risk of wound complications.
All patients presenting to the Greenville Health System Hernia Center who meet the inclusion
      criteria will be considered for enrollment. Patients who qualify and agree to participate
      will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular
      ventral hernia repair. Data to be collected includes the following: demographic information,
      medical characteristics, medications, medical and surgical history, operative details,
      hospital stay data, and patient-reported outcomes via a quality of life questionnaire.
      Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence
time frame: Through study completion, an average of 2 years
description: A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.
measure: All surgical site occurrences
time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Surgical site occurrences requiring procedural intervention
time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: All surgical site infections
time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Surgical site infections requiring procedural intervention
time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Length of stay at hospital measured in days
time frame: Time from procedure until discharge, an expected range of 2 to10 days
measure: Operative time (procedure start to procedure finish measured in minutes)
time frame: Day of surgery
measure: Quality of Life via questionnaire
time frame: Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
measure: Cost for hospital charges from billing office
time frame: Through study completion, an average of 2 years
arm group label: robotic ventral hernia repair (VHR)
arm group type: Active Comparator
description: Robotic VHR
arm group label: open ventral hernia repair (VHR)
arm group type: Active Comparator
description: Open VHR
intervention type: Procedure
intervention name: open ventral hernia repair
description: An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia.
arm group label: open ventral hernia repair (VHR)
intervention type: Procedure
intervention name: robotic ventral hernia repair
description: A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip.
arm group label: robotic ventral hernia repair (VHR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremy A Warren, MD
role: Principal Investigator
affiliation: Prisma Health-Upstate
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Ventral
sharing ipd: Yes
ipd description: All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.