<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/NCT04461054</url>
  </required_header>
  <id_info>
    <org_study_id>Colon USP</org_study_id>
    <nct_id>NCT04461054</nct_id>
  </id_info>
  <brief_title>Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?</brief_title>
  <official_title>Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leonardo Bustamante-Lopez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rodrigo Ambar Pinto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</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>
      Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common&#xD;
      surgeries for colorectal cancer are right and left colectomy.&#xD;
&#xD;
      Objective: To compare perioperative morbidity of the right versus left colectomy for cancer,&#xD;
      as well as the quality of laparoscopic oncologic resection of both procedures. Methods:&#xD;
      Retrospective analysis of prospectively collected data from patients operated at the&#xD;
      University of São Paulo School of Medicine, between 2006 and 2016. Postoperative&#xD;
      complications were classified with scale within 30 days after surgery. Grade III or greater&#xD;
      was considered serious complication. Quality of oncologic resection was assessed by the&#xD;
      average number of lymph nodes harvested and surgical margins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common&#xD;
      surgeries for colorectal cancer are right and left colectomy.&#xD;
&#xD;
      This retrospective analysis of prospectively collected data from patients operated at the&#xD;
      University of São Paulo School of Medicine, between 2006 and 2016. Postoperative&#xD;
      complications were classified by scale within 30 days after surgery. There were 332 patients&#xD;
      operated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Postoperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>Complications</description>
  </primary_outcome>
  <enrollment type="Anticipated">332</enrollment>
  <condition>Colorectal Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        colon adenocarcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: patients who underwent laparoscopic right or left elective colectomy&#xD;
        for colon adenocarcinoma.&#xD;
&#xD;
        Exclusion Criteria: Patients who underwent total colectomy&#xD;
&#xD;
          -  Resections that included the rectum&#xD;
&#xD;
          -  Exclusive transverse resections&#xD;
&#xD;
          -  Multivisceral resections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo A Pinto, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leonardo A Bustamante-Lopez, MD, PhD</last_name>
    <phone>55 11 985000091</phone>
    <email>leonardoabustamante@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medicine School, Sao Paulo University</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonardo A Bustamante, Surgeon</last_name>
      <phone>55 11 985000091</phone>
      <email>leo708@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Leonardo A Bustamante L, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Leonardo Bustamante-Lopez</investigator_full_name>
    <investigator_title>Colorectal Coordinator of Research at the Sao Paulo University</investigator_title>
  </responsible_party>
  <keyword>colectomy</keyword>
  <keyword>colorectal</keyword>
  <keyword>laparoscopy</keyword>
  <!-- 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/NCT04461054
org study id: Colon USP
nct id: NCT04461054
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common
      surgeries for colorectal cancer are right and left colectomy.

      Objective: To compare perioperative morbidity of the right versus left colectomy for cancer,
      as well as the quality of laparoscopic oncologic resection of both procedures. Methods:
      Retrospective analysis of prospectively collected data from patients operated at the
      University of São Paulo School of Medicine, between 2006 and 2016. Postoperative
      complications were classified with scale within 30 days after surgery. Grade III or greater
      was considered serious complication. Quality of oncologic resection was assessed by the
      average number of lymph nodes harvested and surgical margins.
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common
      surgeries for colorectal cancer are right and left colectomy.

      This retrospective analysis of prospectively collected data from patients operated at the
      University of São Paulo School of Medicine, between 2006 and 2016. Postoperative
      complications were classified by scale within 30 days after surgery. There were 332 patients
      operated.
observational model: Cohort
time perspective: Retrospective
measure: Postoperative complications
time frame: 30 days
description: Complications
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rodrigo A Pinto, MD, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Leonardo A Bustamante-Lopez, MD, PhD
phone: 55 11 985000091
email: leonardoabustamante@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Leonardo Bustamante-Lopez
investigator title: Colorectal Coordinator of Research at the Sao Paulo University