<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/NCT04495023</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0356</org_study_id>
    <nct_id>NCT04495023</nct_id>
  </id_info>
  <brief_title>Left Elective Colectomy in Renal Transplanted Patients</brief_title>
  <acronym>LECoRT</acronym>
  <official_title>Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Visceral and Digestive Surgery, Centre hospitalier de Dunkerque</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Aim of the study :&#xD;
&#xD;
      To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted&#xD;
      population.&#xD;
&#xD;
      Methods :&#xD;
&#xD;
      From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a&#xD;
      referral center were prospectively collected.&#xD;
&#xD;
      Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was&#xD;
      separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted&#xD;
      patients (C-group) Short and longterm outcomes were compared between the two groups.&#xD;
&#xD;
      Primary outcome :&#xD;
&#xD;
      90 days postoperative anastomotic leak rate&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From January 2010 to December 2015, data from patients requiring an elective left colectomy&#xD;
      for benign or malignant indication were collected prospectively in our colorectal surgery&#xD;
      database.&#xD;
&#xD;
      According to our exclusion criterial patients were retrospectively divided into two groups:&#xD;
      kidney transplant recipients (KTR-group) and control group (C-group).&#xD;
&#xD;
      The surgical indication for an oncologic left colectomy was retained by the expert surgeon,&#xD;
      after a multidisciplinary conversation meeting comprising at least one surgeon, one&#xD;
      gastroenterologist, one nephrologist, one radiologist and one oncologist. The surgical&#xD;
      indication for diverticular disease was based on French guidelines.&#xD;
&#xD;
      Demographic, clinical, intraoperative and postoperative, histological, length of hospital&#xD;
      stay and mortality data were collected over a 90-day period following the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</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>Rate of Anastomotic leak after left elective colectomy</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Anastomotic leak according to the International Study Group of Rectal Cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long term outcomes</measure>
    <time_frame>1 day</time_frame>
    <description>Status at the date of latest news</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Left Elective Colectomy</condition>
  <condition>Renal Transplanted Patients</condition>
  <arm_group>
    <arm_group_label>Group 1 (Kidney transplanted patients)</arm_group_label>
    <description>Group 1: Kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy All kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Non-transplanted patients)</arm_group_label>
    <description>Group 2 : Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left elective colectomy</intervention_name>
    <description>Open or laparoscopic left elective colectomy with colo-rectal anastomosis</description>
    <arm_group_label>Group 1 (Kidney transplanted patients)</arm_group_label>
    <arm_group_label>Group 2 (Non-transplanted patients)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who Open or laparoscopic left elective colectomy with colo-rectal anastomosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Open or laparoscopic left elective colectomy with colo-rectal anastomosis&#xD;
&#xD;
          -  age &gt; 18 y.o.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  past history of rectal surgery&#xD;
&#xD;
          -  ASA I&#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>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benign or malign pathology</keyword>
  <keyword>Renal transplanted patients</keyword>
  <keyword>Anastomotic leakage</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/NCT04495023
org study id: RECHMPL20_0356
nct id: NCT04495023
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study :

      To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted
      population.

      Methods :

      From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a
      referral center were prospectively collected.

      Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was
      separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted
      patients (C-group) Short and longterm outcomes were compared between the two groups.

      Primary outcome :

      90 days postoperative anastomotic leak rate
From January 2010 to December 2015, data from patients requiring an elective left colectomy
      for benign or malignant indication were collected prospectively in our colorectal surgery
      database.

      According to our exclusion criterial patients were retrospectively divided into two groups:
      kidney transplant recipients (KTR-group) and control group (C-group).

      The surgical indication for an oncologic left colectomy was retained by the expert surgeon,
      after a multidisciplinary conversation meeting comprising at least one surgeon, one
      gastroenterologist, one nephrologist, one radiologist and one oncologist. The surgical
      indication for diverticular disease was based on French guidelines.

      Demographic, clinical, intraoperative and postoperative, histological, length of hospital
      stay and mortality data were collected over a 90-day period following the intervention.
observational model: Case-Control
time perspective: Retrospective
measure: Rate of Anastomotic leak after left elective colectomy
time frame: 90 days postoperative
description: Anastomotic leak according to the International Study Group of Rectal Cancer
measure: Long term outcomes
time frame: 1 day
description: Status at the date of latest news
arm group label: Group 1 (Kidney transplanted patients)
description: Group 1: Kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy All kidney transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015.
arm group label: Group 2 (Non-transplanted patients)
description: Group 2 : Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy Non-transplanted patients requiring oncologic or non-oncologic left elective colectomy between 01 January 2004 and 31 December 2015.
intervention type: Procedure
intervention name: Left elective colectomy
description: Open or laparoscopic left elective colectomy with colo-rectal anastomosis
arm group label: Group 1 (Kidney transplanted patients)
arm group label: Group 2 (Non-transplanted patients)
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