<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/NCT04429074</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0348</org_study_id>
    <nct_id>NCT04429074</nct_id>
  </id_info>
  <brief_title>Registrar Performances in MIDP</brief_title>
  <official_title>Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aimed to determine whether registrar involvement in minimally invasive distal&#xD;
      pancreatectomy (MIDP) was associated with adverse outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From January 2009 to March 2020, data of all consecutive patients requiring distal&#xD;
      pancreatectomy in our public tertiary hospital were prospectively collected and&#xD;
      retrospectively analyzed.&#xD;
&#xD;
      Registrars were progressively involved for MIDP since 2009 and their experience was: &lt; 5 open&#xD;
      pancreatic resections, &lt; 5 MIDP and at least 30 advanced minimally invasive gastrointestinal&#xD;
      resections.&#xD;
&#xD;
      Outcome of patients who underwent either distal pancreatectomy by the consultant or&#xD;
      registrars were compared.&#xD;
&#xD;
      Our primary outcome was the conversion rate. The secondary outcomes were 90-days&#xD;
      postoperative outcomes including CR-POPF defined and classified according to the 2016 ISGPF&#xD;
      definition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>open conversion rate</measure>
    <time_frame>1 day</time_frame>
    <description>Necessity to swith from minimally invasive approach to open approach during laparoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>1 day</time_frame>
    <description>Duration of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative bloodloss</measure>
    <time_frame>1 day</time_frame>
    <description>Intraoperative bloodloss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative transfusion</measure>
    <time_frame>1 day</time_frame>
    <description>Intraoperative transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severe complications Clavien Dindo&gt;3</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>severe complications Clavien Dindo&gt;3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinically relevant postoperative fistula</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>clinically relevant postoperative fistula (2016 ISGPF definition)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lenght of hospital stay</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>lenght of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>readmission rate</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>readmission rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reoperation rate</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>reoperation rate</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Minimally Invasive Distal Pancreatectomy</condition>
  <arm_group>
    <arm_group_label>Group 1 (Registrar)</arm_group_label>
    <description>Group 1 (Registrar): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a registrar (young specialist surgeon)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Consultant)</arm_group_label>
    <description>Group 2 (Consultant): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a consultant (expert)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimally invasive distal pancreatectomy</intervention_name>
    <description>Minimally invasive distal pancreatectomy</description>
    <arm_group_label>Group 1 (Registrar)</arm_group_label>
    <arm_group_label>Group 2 (Consultant)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent minimally invasive distale pancreatectomy for benign or borderline&#xD;
        pathology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Patients who underwent minimally invasive distale pancreatectomy for benign or borderline&#xD;
        pathology between 2009-2020&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  open distal pancreatectomy&#xD;
&#xD;
          -  minimally invasive distal pancreatectomy for pancreatic cancer&#xD;
&#xD;
          -  20 first consecutive patients operated on by the consultant (learning curve)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>REGIS SOUCHE</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benign or borderline pathology (non-pancreatic cancer)</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>registrar</keyword>
  <keyword>postoperative outcomes</keyword>
  <keyword>pancreatectomy</keyword>
  <keyword>surgery</keyword>
  <keyword>pancreas</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</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/NCT04429074
org study id: RECHMPL20_0348
nct id: NCT04429074
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to determine whether registrar involvement in minimally invasive distal
      pancreatectomy (MIDP) was associated with adverse outcomes.
From January 2009 to March 2020, data of all consecutive patients requiring distal
      pancreatectomy in our public tertiary hospital were prospectively collected and
      retrospectively analyzed.

      Registrars were progressively involved for MIDP since 2009 and their experience was: < 5 open
      pancreatic resections, < 5 MIDP and at least 30 advanced minimally invasive gastrointestinal
      resections.

      Outcome of patients who underwent either distal pancreatectomy by the consultant or
      registrars were compared.

      Our primary outcome was the conversion rate. The secondary outcomes were 90-days
      postoperative outcomes including CR-POPF defined and classified according to the 2016 ISGPF
      definition.
observational model: Case-Control
time perspective: Retrospective
measure: open conversion rate
time frame: 1 day
description: Necessity to swith from minimally invasive approach to open approach during laparoscopy
measure: Duration of surgery
time frame: 1 day
description: Duration of surgery
measure: Intraoperative bloodloss
time frame: 1 day
description: Intraoperative bloodloss
measure: Intraoperative transfusion
time frame: 1 day
description: Intraoperative transfusion
measure: severe complications Clavien Dindo>3
time frame: 90 days postoperative
description: severe complications Clavien Dindo>3
measure: postoperative complications
time frame: 90 days postoperative
description: postoperative complications
measure: clinically relevant postoperative fistula
time frame: 90 days postoperative
description: clinically relevant postoperative fistula (2016 ISGPF definition)
measure: lenght of hospital stay
time frame: 90 days postoperative
description: lenght of hospital stay
measure: readmission rate
time frame: 90 days postoperative
description: readmission rate
measure: reoperation rate
time frame: 90 days postoperative
description: reoperation rate
arm group label: Group 1 (Registrar)
description: Group 1 (Registrar): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a registrar (young specialist surgeon)
arm group label: Group 2 (Consultant)
description: Group 2 (Consultant): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a consultant (expert)
intervention type: Procedure
intervention name: Minimally invasive distal pancreatectomy
description: Minimally invasive distal pancreatectomy
arm group label: Group 1 (Registrar)
arm group label: Group 2 (Consultant)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: REGIS SOUCHE
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC