<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/NCT04487522</url>
  </required_header>
  <id_info>
    <org_study_id>RECOVER</org_study_id>
    <nct_id>NCT04487522</nct_id>
  </id_info>
  <brief_title>Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)</brief_title>
  <acronym>RECOVER</acronym>
  <official_title>RECOVER: a pRospECtive evaluatiOn of Pain After Retromuscular VEntRal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuitive Surgical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to explore the difference in outcomes relating to pain and quality of life&#xD;
      after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, observational study assessing outcomes relating to pain&#xD;
      and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted&#xD;
      retromuscular ventral hernia repair. The study will focus on short-term post-operative&#xD;
      outcomes through 3 months. The study will also collect recurrence data through 1 year. During&#xD;
      the post-operative period through 3 months, pain medication intake, subject reported pain (on&#xD;
      post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and&#xD;
      1 year) and incidence of intra-operative and post-operative adverse events related to the&#xD;
      ventral hernia repair will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores</measure>
    <time_frame>7 days</time_frame>
    <description>Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Narcotic usage</measure>
    <time_frame>4 weeks</time_frame>
    <description>Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-opioid prescription pain medication usage</measure>
    <time_frame>4 weeks</time_frame>
    <description>Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Narcotic usage</measure>
    <time_frame>3 months</time_frame>
    <description>Narcotic usage related to the retromuscular ventral hernia repair.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-opioid prescription pain medication usage</measure>
    <time_frame>3 months</time_frame>
    <description>Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Over the counter pain medication usage</measure>
    <time_frame>4 weeks</time_frame>
    <description>Over the counter (OTC) pain medication usage after the retromuscular ventral hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-ups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for refill prescription pain medication</measure>
    <time_frame>4 weeks</time_frame>
    <description>Need for refill of prescription pain medication after the retromuscular ventral hernia repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS 3a pain scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Start of procedure to discharge from the hospital (check out time), up to an approximate of one week</time_frame>
    <description>Duration of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair</measure>
    <time_frame>intraoperatve</time_frame>
    <description>Intra-operative adverse events related to the retromuscular ventral hernia repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative adverse events related to the retromuscular ventral hernia repair</measure>
    <time_frame>3 months</time_frame>
    <description>Post-operative adverse events related to the retromuscular ventral hernia repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hernia recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Hernia recurrence after the retromuscular ventral hernia repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-3L QOL scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>Retromuscular ventral hernia repair</arm_group_label>
    <description>These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retromuscular TAR ventral hernia repair</arm_group_label>
    <description>These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open retromuscular ventral hernia repair</intervention_name>
    <description>With the subject under general anesthesia, a single incision is made in the abdomen. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.</description>
    <arm_group_label>Retromuscular TAR ventral hernia repair</arm_group_label>
    <arm_group_label>Retromuscular ventral hernia repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic retromuscular ventral hernia repair</intervention_name>
    <description>With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.</description>
    <arm_group_label>Retromuscular ventral hernia repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic-assisted retromuscular ventral hernia repair</intervention_name>
    <description>With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.</description>
    <arm_group_label>Retromuscular TAR ventral hernia repair</arm_group_label>
    <arm_group_label>Retromuscular ventral hernia repair</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who&#xD;
        meet all eligibility criteria will be considered for enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is between 18 and 89 years of age&#xD;
&#xD;
          -  Subject is a candidate for an elective retromuscular ventral hernia repair under&#xD;
             general anesthesia&#xD;
&#xD;
          -  Subject has access to complete study assessments electronically and agrees to comply&#xD;
             with all follow-up requirements&#xD;
&#xD;
          -  Ventral hernia is &gt;= 4cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who will have an emergent hernia repair&#xD;
&#xD;
          -  Subject has a parastomal hernia (i.e. hernia related to ostomy formation)&#xD;
&#xD;
          -  Subject with a history of chronic pain and/or taking daily pain medication for &gt;6&#xD;
             weeks&#xD;
&#xD;
          -  Subject wtih a history of substance abuse (excluding marijuana) and/or current (within&#xD;
             30 days) narcotic use&#xD;
&#xD;
          -  Subject with a history of MRSA infection&#xD;
&#xD;
          -  Subject with HbA1c level &gt; 8.5%&#xD;
&#xD;
          -  Subject undergoing a minimally invasive (MIS) repair who will require the use of&#xD;
             Exparel during the surgical procedure&#xD;
&#xD;
          -  Subject who will undergo a concomitant hernia repair or any other concomitant&#xD;
             procedure&#xD;
&#xD;
          -  Subject has cirrhosis&#xD;
&#xD;
          -  Current nicotine use (including vaping) within the past 30 days&#xD;
&#xD;
          -  Subject is contraindicated for general anesthesia or surgery&#xD;
&#xD;
          -  Subject has a known bleeding or clotting disorder&#xD;
&#xD;
          -  Pregnant or suspected pregnancy&#xD;
&#xD;
          -  Subject is mentally handicapped or has a psychological disorder or severe systemic&#xD;
             illness that would preclude compliance with the study requirements or ability to&#xD;
             provide informed consent&#xD;
&#xD;
          -  Subject belonging to other vulnerable population, e.g., prisoner or ward of state&#xD;
&#xD;
          -  Subject is currently participating in another interventional research study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Jennifer Mueller</last_name>
    <phone>15105529880</phone>
    <email>jennifer.mueller@intusurg.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaiser Foundation Research Institute, Oakland/Richmond</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Yip</last_name>
      <email>Jennifer.Yip@kp.org</email>
    </contact>
    <investigator>
      <last_name>Rouzbeh Mostaedi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francisca Maertens, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Nguyen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Research Institute, South Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tashia Orr, MBA</last_name>
      <phone>916-628-1668</phone>
      <email>Tashia.Orr@kp.org</email>
    </contact>
    <investigator>
      <last_name>Sharon Shiraga, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Research Institute, Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nancy Mendelssohn</last_name>
      <phone>650-450-3459</phone>
      <email>Nancy.D.Mendelssohn@kp.org</email>
    </contact>
    <investigator>
      <last_name>Elliott Brill, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maureen Tedesco, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jong-Ping Lu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amid Keshavarzi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Research Institute, Walnut Creek</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard M Joven</last_name>
      <email>Richard.M.Joven@kp.org</email>
    </contact>
    <investigator>
      <last_name>Jacob Spivak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Bell, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</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>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_browse>
  <!-- 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/NCT04487522
org study id: RECOVER
nct id: NCT04487522
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to explore the difference in outcomes relating to pain and quality of life
      after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.
This is a prospective, multicenter, observational study assessing outcomes relating to pain
      and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted
      retromuscular ventral hernia repair. The study will focus on short-term post-operative
      outcomes through 3 months. The study will also collect recurrence data through 1 year. During
      the post-operative period through 3 months, pain medication intake, subject reported pain (on
      post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and
      1 year) and incidence of intra-operative and post-operative adverse events related to the
      ventral hernia repair will be collected.
observational model: Case-Only
time perspective: Prospective
measure: Pain scores
time frame: 7 days
description: Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
measure: Narcotic usage
time frame: 4 weeks
description: Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.
measure: Non-opioid prescription pain medication usage
time frame: 4 weeks
description: Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
measure: Narcotic usage
time frame: 3 months
description: Narcotic usage related to the retromuscular ventral hernia repair.
measure: Non-opioid prescription pain medication usage
time frame: 3 months
description: Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.
measure: Over the counter pain medication usage
time frame: 4 weeks
description: Over the counter (OTC) pain medication usage after the retromuscular ventral hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-ups
measure: Need for refill prescription pain medication
time frame: 4 weeks
description: Need for refill of prescription pain medication after the retromuscular ventral hernia repair
measure: PROMIS 3a pain scores
time frame: 4 weeks
description: Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
measure: Hospital length of stay
time frame: Start of procedure to discharge from the hospital (check out time), up to an approximate of one week
description: Duration of hospital stay
measure: Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair
time frame: intraoperatve
description: Intra-operative adverse events related to the retromuscular ventral hernia repair
measure: Incidence of postoperative adverse events related to the retromuscular ventral hernia repair
time frame: 3 months
description: Post-operative adverse events related to the retromuscular ventral hernia repair
measure: Hernia recurrence
time frame: 1 year
description: Hernia recurrence after the retromuscular ventral hernia repair
measure: EQ-5D-3L QOL scores
time frame: 4 weeks
description: Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
arm group label: Retromuscular ventral hernia repair
description: These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.
arm group label: Retromuscular TAR ventral hernia repair
description: These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.
intervention type: Procedure
intervention name: Open retromuscular ventral hernia repair
description: With the subject under general anesthesia, a single incision is made in the abdomen. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
arm group label: Retromuscular TAR ventral hernia repair
arm group label: Retromuscular ventral hernia repair
intervention type: Procedure
intervention name: Laparoscopic retromuscular ventral hernia repair
description: With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
arm group label: Retromuscular ventral hernia repair
intervention type: Device
intervention name: Robotic-assisted retromuscular ventral hernia repair
description: With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
arm group label: Retromuscular TAR ventral hernia repair
arm group label: Retromuscular ventral hernia repair
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
last name: Jennifer Mueller
phone: 15105529880
email: jennifer.mueller@intusurg.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Ventral