<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/NCT02975401</url>
  </required_header>
  <id_info>
    <org_study_id>Robust_1</org_study_id>
    <nct_id>NCT02975401</nct_id>
  </id_info>
  <brief_title>Robotic Utility for Surgical Treatment of Groin Hernias</brief_title>
  <acronym>Robust _1</acronym>
  <official_title>Prospective Observational Cohort Study on Robot-assisted Laparoscopic Hernia Repair (rTAPP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Algemeen Ziekenhuis Maria Middelares</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Algemeen Ziekenhuis Maria Middelares</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the measurement of the evolution of the operation time during&#xD;
      the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50&#xD;
      patients treated in Maria Middelares in laparoscopic rTAPP technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients&#xD;
      in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of&#xD;
      patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively&#xD;
      treated and the technique has a low recurrence rate and low frequency of long-term side&#xD;
      effects.&#xD;
&#xD;
      Robot-assisted laparoscopic surgery has become standard in urology for resection of the&#xD;
      prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently&#xD;
      working on the introduction of robotic-assisted surgery for resection of colon and rectal&#xD;
      cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the&#xD;
      applicability of this technology within the field of general surgery.&#xD;
&#xD;
      For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and&#xD;
      incisional hernia's), currently only surgeons in the US have experiences in structured&#xD;
      treatment programs.&#xD;
&#xD;
      From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery,&#xD;
      including the laparoscopic TAPP inguinal hernia repair.&#xD;
&#xD;
      Main obstacles to the introduction of robot technology in abdominal wall surgery are&#xD;
      prolonged preparation time in the operating room required for installation of the robot, and&#xD;
      higher material costs related to the robot-assisted surgery. However, there are few precise&#xD;
      data available on the exact size of extra time or increased costs related to the introduction&#xD;
      of robotic assisted surgery in a program for abdominal surgery.&#xD;
&#xD;
      The purpose of this study is the measurement of the evolution of the operation time during&#xD;
      the start-up phase of robotic-assisted surgery for the treatment of inguinal hernias by 50&#xD;
      patients in Maria Middelares hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>duration of the operation</measure>
    <time_frame>from the start of the operation until the end of the operation, approximately 3 hours</time_frame>
    <description>Recording of the operation time needed for robot-assisted TAPP groin hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intra-operative complications</measure>
    <time_frame>until 4 weeks post-operative</time_frame>
    <description>Intra-operative complications registered until 4 weeks post-operative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative complications</measure>
    <time_frame>until 4 weeks post-operative</time_frame>
    <description>Post-operative complications detected until 4 weeks after hernia repair by clinical follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>until 4 weeks post-operative</time_frame>
    <description>Quality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up.</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Hernia, Inguinal</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>rTAPP technique</intervention_name>
    <description>robot-assisted rTAPP technique</description>
    <other_name>laparoscopic robot-assisted TAPP technique</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All eligible patients who are scheduled for laparoscopic repair of a unilateral or&#xD;
        bilateral inguinal hernia. A total of 50 patients will be enrolled in this observational&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 patients selected and operated by the PI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under the age of 18&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
&#xD;
          -  recurrent groin hernia&#xD;
&#xD;
          -  no Informed Consent&#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>Filip Muysoms, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maria Middelares hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Algemeen Ziekenhuis Maria Middelares</investigator_affiliation>
    <investigator_full_name>Filip Muysoms</investigator_full_name>
    <investigator_title>surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <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/NCT02975401
org study id: Robust_1
nct id: NCT02975401
lead sponsor: 
has dmc: No
The purpose of this study is the measurement of the evolution of the operation time during
      the start-up phase of robotic-assisted surgery for the treatment of inguinal hernia's of 50
      patients treated in Maria Middelares in laparoscopic rTAPP technique.
Minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients
      in Maria Middelares, Ghent. A previously conducted study demonstrated that the symptoms of
      patients with inguinal hernias (verified via EuraHS Quality of Life score) can be effectively
      treated and the technique has a low recurrence rate and low frequency of long-term side
      effects.

      Robot-assisted laparoscopic surgery has become standard in urology for resection of the
      prostate carcinoma. In general abdominal surgery, a large group of surgeons are currently
      working on the introduction of robotic-assisted surgery for resection of colon and rectal
      cancer in their daily practice. The third generation robot (DaVinci Xi), has extended the
      applicability of this technology within the field of general surgery.

      For the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and
      incisional hernia's), currently only surgeons in the US have experiences in structured
      treatment programs.

      From September 1, 2016 Maria Middelares hospital will introduce robot-assisted surgery,
      including the laparoscopic TAPP inguinal hernia repair.

      Main obstacles to the introduction of robot technology in abdominal wall surgery are
      prolonged preparation time in the operating room required for installation of the robot, and
      higher material costs related to the robot-assisted surgery. However, there are few precise
      data available on the exact size of extra time or increased costs related to the introduction
      of robotic assisted surgery in a program for abdominal surgery.

      The purpose of this study is the measurement of the evolution of the operation time during
      the start-up phase of robotic-assisted surgery for the treatment of inguinal hernias by 50
      patients in Maria Middelares hospital.
observational model: Cohort
time perspective: Prospective
measure: duration of the operation
time frame: from the start of the operation until the end of the operation, approximately 3 hours
description: Recording of the operation time needed for robot-assisted TAPP groin hernia repair
measure: intra-operative complications
time frame: until 4 weeks post-operative
description: Intra-operative complications registered until 4 weeks post-operative
measure: post-operative complications
time frame: until 4 weeks post-operative
description: Post-operative complications detected until 4 weeks after hernia repair by clinical follow up.
measure: Quality of Life
time frame: until 4 weeks post-operative
description: Quality of Life measured with the EuraHS QoL score preoperative and until 4 weeks after hernia repair by clinical follow up.
intervention type: Procedure
intervention name: rTAPP technique
description: robot-assisted rTAPP technique
other name: laparoscopic robot-assisted TAPP technique
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Filip Muysoms, MD, PhD
role: Principal Investigator
affiliation: Maria Middelares hospital
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Algemeen Ziekenhuis Maria Middelares
investigator full name: Filip Muysoms
investigator title: surgeon
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No