<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/NCT03281070</url>
  </required_header>
  <id_info>
    <org_study_id>CR-AL</org_study_id>
    <nct_id>NCT03281070</nct_id>
  </id_info>
  <brief_title>Anastomotic Leakage After Anterior Resection of Rectal Cancer</brief_title>
  <official_title>The Incidence and Risk Factors of Anastomotic Leakage After Anterior Resection of Rectal Cancer: a Multi-site Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior&#xD;
      resection of rectal cancer. This complication compromises both short term and long term&#xD;
      outcome of patients. The incidence of AL after anterior resection was approximately 6-11%.&#xD;
      Although several risk factors for AL such as male sex, smoking, tumor location, longer&#xD;
      operative time, intraoperative blood loss had been reported in previous studies, the&#xD;
      incidence of AL did not meet a significant decrease. So far there is no multi-site&#xD;
      observational study on incidence and risk factors of AL after anterior resection in China,&#xD;
      therefore this study aims to work on this issue and provide evidence for clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2018</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>Anastomotic leakage</measure>
    <time_frame>14 days after surgery</time_frame>
    <description>Anastomotic leakage is defined as a defect of the intestinal wall integrity at the colorectal anastomotic site leading to a communication between the intra- and extraluminal compartments.</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Rectal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Rectal cancer patients who underwent anterior resection with or without postoperative&#xD;
        anastomotic leakage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adenocarcinoma of the rectum by biopsy&#xD;
&#xD;
          -  single lesion&#xD;
&#xD;
          -  anterior resection was performed&#xD;
&#xD;
          -  anastomosis using circular stapler&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of colorectal cancer surgery&#xD;
&#xD;
          -  emergency surgery because of bowel obstruction, bleeding or perforation&#xD;
&#xD;
          -  colo-anal anastomosis&#xD;
&#xD;
          -  subtotal colectomy&#xD;
&#xD;
          -  total colectomy&#xD;
&#xD;
          -  abdominal perineal resection&#xD;
&#xD;
          -  Hartmann procedure&#xD;
&#xD;
          -  pull out anastomosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hongwei Yao, M.D.</last_name>
    <phone>+8613611015609</phone>
    <email>yaohongwei@medmail.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jun Li, M.D.</last_name>
    <phone>+8613811379656</phone>
    <email>lijunsy2002@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongwei Yao, M.D.</last_name>
      <phone>+8613611015609</phone>
      <email>yaohongwei@medmail.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Zhongtao Zhang</investigator_full_name>
    <investigator_title>Department of General Surgery</investigator_title>
  </responsible_party>
  <keyword>Anastomotic leakage</keyword>
  <keyword>Anterior resection</keyword>
  <keyword>Risk factors</keyword>
  <keyword>Incidence</keyword>
  <keyword>Rectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Anastomotic Leak</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/NCT03281070
org study id: CR-AL
nct id: NCT03281070
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior
      resection of rectal cancer. This complication compromises both short term and long term
      outcome of patients. The incidence of AL after anterior resection was approximately 6-11%.
      Although several risk factors for AL such as male sex, smoking, tumor location, longer
      operative time, intraoperative blood loss had been reported in previous studies, the
      incidence of AL did not meet a significant decrease. So far there is no multi-site
      observational study on incidence and risk factors of AL after anterior resection in China,
      therefore this study aims to work on this issue and provide evidence for clinical practice.
observational model: Cohort
time perspective: Retrospective
measure: Anastomotic leakage
time frame: 14 days after surgery
description: Anastomotic leakage is defined as a defect of the intestinal wall integrity at the colorectal anastomotic site leading to a communication between the intra- and extraluminal compartments.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hongwei Yao, M.D.
phone: +8613611015609
email: yaohongwei@medmail.com.cn
last name: Jun Li, M.D.
phone: +8613811379656
email: lijunsy2002@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Zhongtao Zhang
investigator title: Department of General Surgery
mesh term: Rectal Neoplasms
mesh term: Anastomotic Leak