<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/NCT03776370</url>
  </required_header>
  <id_info>
    <org_study_id>20181155</org_study_id>
    <nct_id>NCT03776370</nct_id>
  </id_info>
  <brief_title>Preserving Left Colonic Artery During Radical Resection of Rectal Cancer</brief_title>
  <official_title>A Clinical Cohort Study on the Effect of Preserving Left Colonic Artery During Radical Resection of Rectal Cancer on Anastomotic Leakage and Oncology Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military Medical University</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>
      To evaluate the feasibility and clinical significance of preserving left colonic artery in&#xD;
      rectal cancer surgery.The investigators will focus on the effect of preserving left colonic&#xD;
      artery during radical resection of rectal cancer on anastomotic leakage and oncology&#xD;
      efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators performed three-dimensional (3D) reconstruction to investigate the vascular&#xD;
      anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help&#xD;
      make pre-operative strategies of rectal cancer surgery.The investigators will preserving the&#xD;
      left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical&#xD;
      significance.The investigators will focus on the effect of preserving left colonic artery&#xD;
      during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>The incidence of postoperative anastomotic leakage was compared between the two groups.</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The distant metastasis rates of rectal cancer between the two groups were compared.</measure>
    <time_frame>Two years after surgery</time_frame>
    <description>The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The local recurrence rates of rectal cancer between the two groups were compared.</measure>
    <time_frame>Two years after surgery</time_frame>
    <description>The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The five-year survival rates of rectal cancer between the two groups were compared.</measure>
    <time_frame>Five years after surgery</time_frame>
    <description>The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Postoperative Complications</condition>
  <condition>Proteinosis</condition>
  <arm_group>
    <arm_group_label>Preserve the left colonic artery</arm_group_label>
    <description>Preservation of left colonic artery in rectal cancer surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The left colonic artery is not preserved</arm_group_label>
    <description>The left colonic artery was dissected in rectal cancer surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preserve the left colonic artery</intervention_name>
    <description>Preservation of left colonic artery in rectal cancer surgery.</description>
    <arm_group_label>Preserve the left colonic artery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The left colonic artery is not preserved</intervention_name>
    <description>The left colonic artery was dissected in rectal cancer surgery.</description>
    <arm_group_label>The left colonic artery is not preserved</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent laparoscopic or robotic anterior rectal resections carried out by&#xD;
        two surgeons at Daping Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathological biopsy confirmed adenocarcinoma of the rectum；&#xD;
&#xD;
          2. Preoperative assessment of tolerance to surgery without major organ dysfunction；&#xD;
&#xD;
          3. Patients must be able to understand and voluntarily sign written informed consent；&#xD;
&#xD;
          4. The surgical method is laparoscopic or robotic anterior rectal cancer resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient cannot tolerate the operation；&#xD;
&#xD;
          2. Refusal to sign informed consent；&#xD;
&#xD;
          3. Patients with distant metastasis of rectal cancer；&#xD;
&#xD;
          4. The surgical method was changed to miles or Hartman;&#xD;
&#xD;
          5. Unable to complete the follow - up&#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>Wei d tong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Army Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>zongming,Kang</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>zongming,Kang</name>
      <address>
        <city>Yuzhong</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.</citation>
    <PMID>29501795</PMID>
  </results_reference>
  <results_reference>
    <citation>Sekimoto M, Takemasa I, Mizushima T, Ikeda M, Yamamoto H, Doki Y, Mori M. Laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery. Surg Endosc. 2011 Mar;25(3):861-6. doi: 10.1007/s00464-010-1284-7. Epub 2010 Aug 20.</citation>
    <PMID>20725744</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Weidong Tong</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>Postoperative Complications</keyword>
  <keyword>Preserve the left colonic artery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Postoperative Complications</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/NCT03776370
org study id: 20181155
nct id: NCT03776370
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the feasibility and clinical significance of preserving left colonic artery in
      rectal cancer surgery.The investigators will focus on the effect of preserving left colonic
      artery during radical resection of rectal cancer on anastomotic leakage and oncology
      efficacy.
The investigators performed three-dimensional (3D) reconstruction to investigate the vascular
      anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help
      make pre-operative strategies of rectal cancer surgery.The investigators will preserving the
      left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical
      significance.The investigators will focus on the effect of preserving left colonic artery
      during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
observational model: Cohort
time perspective: Prospective
measure: The incidence of postoperative anastomotic leakage was compared between the two groups.
time frame: Within 30 days after surgery
description: The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.
measure: The distant metastasis rates of rectal cancer between the two groups were compared.
time frame: Two years after surgery
description: The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.
measure: The local recurrence rates of rectal cancer between the two groups were compared.
time frame: Two years after surgery
description: The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.
measure: The five-year survival rates of rectal cancer between the two groups were compared.
time frame: Five years after surgery
description: The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.
arm group label: Preserve the left colonic artery
description: Preservation of left colonic artery in rectal cancer surgery.
arm group label: The left colonic artery is not preserved
description: The left colonic artery was dissected in rectal cancer surgery
intervention type: Procedure
intervention name: Preserve the left colonic artery
description: Preservation of left colonic artery in rectal cancer surgery.
arm group label: Preserve the left colonic artery
intervention type: Procedure
intervention name: The left colonic artery is not preserved
description: The left colonic artery was dissected in rectal cancer surgery.
arm group label: The left colonic artery is not preserved
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wei d tong, PhD
role: Principal Investigator
affiliation: Army Military Medical University
facility: 
facility: 
country: China
citation: Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.
PMID: 29501795
citation: Sekimoto M, Takemasa I, Mizushima T, Ikeda M, Yamamoto H, Doki Y, Mori M. Laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery. Surg Endosc. 2011 Mar;25(3):861-6. doi: 10.1007/s00464-010-1284-7. Epub 2010 Aug 20.
PMID: 20725744
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Weidong Tong
investigator title: Clinical Professor
mesh term: Rectal Neoplasms
mesh term: Postoperative Complications
sharing ipd: No