<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/NCT04431271</url>
  </required_header>
  <id_info>
    <org_study_id>EASTER study</org_study_id>
    <nct_id>NCT04431271</nct_id>
  </id_info>
  <brief_title>Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair</brief_title>
  <acronym>EASTER</acronym>
  <official_title>Retrospective Comparative Study on Costs of Conventional Versus Robotic Assisted Laparoscopic Groin Hernia Repair</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>Yes</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>
      The material cost for robotic groin hernia repair is higher than for conventional&#xD;
      laparoscopic surgery. In this study, this amount will be quantified and possible differences&#xD;
      in early postoperative course, hospital stay and readmission rate that could influence the&#xD;
      cost/benefit ratio for robotic groin hernia surgery will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Robot-assisted groin hernia repair has been introduced in AZ Maria Middelares hospital since&#xD;
      September 2016. In these procedures, the daVinci robot is being used to perform minimal&#xD;
      invasive repair of these hernias. At the moment, this technique is frequently being used for&#xD;
      groin hernia repair. Literature shows a clear benefit of robot-assisted versus open repair.&#xD;
      Hospital stay decreases and complications are less frequently observed in patients who&#xD;
      underwent minimal invasive repair (Henriksen NA et al., 2018).&#xD;
&#xD;
      On the other hand, the benefits of robot-assisted repair are less obvious compared to&#xD;
      conventional laparoscopy. Many robot-trained surgeons are in favor of robot-assisted repair,&#xD;
      but current literature is still inconclusive about the economic feasibility of robot-assisted&#xD;
      groin hernia repair as standard of care.&#xD;
&#xD;
      This retrospective observational study is primarily designed to analyze the additional cost&#xD;
      of robot-assisted groin hernia repair compared to conventional laparoscopic repair. A&#xD;
      cost-benefit analysis will be carried out for groin hernia repairs performed by the same&#xD;
      surgeon (Dr. Filip Muysoms) in the period 2016-2019.&#xD;
&#xD;
      As primary endpoint, direct costs related to the introduction of robot-assisted groin hernia&#xD;
      repair will be analyzed. These are: material costs, costs related to hospital stay, honoraria&#xD;
      and costs related to intrahospital complications. A comparison will be made between&#xD;
      conventional laparoscopic and robot-assisted groin hernia repair.&#xD;
&#xD;
      As secondary endpoint, indirect costs will be compared between both groups. These include&#xD;
      costs related to late complications and readmissions related to the index operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</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>Direct costs</measure>
    <time_frame>Immediately post hospital discharge</time_frame>
    <description>Material costs, hospitalization costs, specialist fees and costs related to early complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Indirect costs</measure>
    <time_frame>0- 42 days postoperatively</time_frame>
    <description>Late complication costs, readmission costs</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">677</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Robot-assisted laparoscopy</arm_group_label>
    <description>Patients who underwent robot-assisted groin hernia repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional laparoscopy</arm_group_label>
    <description>Patients who underwent conventional laparoscopic groin hernia repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robot-assisted hernia repair</intervention_name>
    <description>Inguinal hernia repair was performed using the DaVinci Xi robotic system</description>
    <arm_group_label>Robot-assisted laparoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who underwent uni-or bilateral groin hernia repair in the period 2015- 2019.&#xD;
        Only patients who underwent minimal-invasive surgery (conventional or robot-assisted&#xD;
        laparoscopy) will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
          -  underwent uni-or bilateral groin hernia repair in the period 2015- 2019&#xD;
&#xD;
          -  surgery through minimal invasive repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  open surgery or conversion from minimal-invasive to open surgery&#xD;
&#xD;
          -  combined procedures&#xD;
&#xD;
          -  age below 18 years&#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>Filip Muysoms, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algemeen Ziekenhuis Maria Middelares</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</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>Principal Investigator</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>
  <!-- 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/NCT04431271
org study id: EASTER study
nct id: NCT04431271
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The material cost for robotic groin hernia repair is higher than for conventional
      laparoscopic surgery. In this study, this amount will be quantified and possible differences
      in early postoperative course, hospital stay and readmission rate that could influence the
      cost/benefit ratio for robotic groin hernia surgery will be analyzed.
Robot-assisted groin hernia repair has been introduced in AZ Maria Middelares hospital since
      September 2016. In these procedures, the daVinci robot is being used to perform minimal
      invasive repair of these hernias. At the moment, this technique is frequently being used for
      groin hernia repair. Literature shows a clear benefit of robot-assisted versus open repair.
      Hospital stay decreases and complications are less frequently observed in patients who
      underwent minimal invasive repair (Henriksen NA et al., 2018).

      On the other hand, the benefits of robot-assisted repair are less obvious compared to
      conventional laparoscopy. Many robot-trained surgeons are in favor of robot-assisted repair,
      but current literature is still inconclusive about the economic feasibility of robot-assisted
      groin hernia repair as standard of care.

      This retrospective observational study is primarily designed to analyze the additional cost
      of robot-assisted groin hernia repair compared to conventional laparoscopic repair. A
      cost-benefit analysis will be carried out for groin hernia repairs performed by the same
      surgeon (Dr. Filip Muysoms) in the period 2016-2019.

      As primary endpoint, direct costs related to the introduction of robot-assisted groin hernia
      repair will be analyzed. These are: material costs, costs related to hospital stay, honoraria
      and costs related to intrahospital complications. A comparison will be made between
      conventional laparoscopic and robot-assisted groin hernia repair.

      As secondary endpoint, indirect costs will be compared between both groups. These include
      costs related to late complications and readmissions related to the index operation.
observational model: Cohort
time perspective: Retrospective
measure: Direct costs
time frame: Immediately post hospital discharge
description: Material costs, hospitalization costs, specialist fees and costs related to early complications
measure: Indirect costs
time frame: 0- 42 days postoperatively
description: Late complication costs, readmission costs
arm group label: Robot-assisted laparoscopy
description: Patients who underwent robot-assisted groin hernia repair
arm group label: Conventional laparoscopy
description: Patients who underwent conventional laparoscopic groin hernia repair
intervention type: Procedure
intervention name: Robot-assisted hernia repair
description: Inguinal hernia repair was performed using the DaVinci Xi robotic system
arm group label: Robot-assisted laparoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Filip Muysoms, MD, PhD
role: Principal Investigator
affiliation: Algemeen Ziekenhuis Maria Middelares
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Algemeen Ziekenhuis Maria Middelares
investigator full name: Filip Muysoms
investigator title: Principal Investigator
mesh term: Hernia
mesh term: Hernia, Inguinal