<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/NCT03253302</url>
  </required_header>
  <id_info>
    <org_study_id>CR-TaTME</org_study_id>
    <nct_id>NCT03253302</nct_id>
  </id_info>
  <brief_title>Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site</brief_title>
  <acronym>LATERAL-01</acronym>
  <official_title>Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoning Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Friendship Hospital</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>
      At present, surgical resection is still the main treatment for the potential cure of rectal&#xD;
      cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or&#xD;
      open surgery for some special patients is really difficult, especially for male, prostate&#xD;
      hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the&#xD;
      mesorectum and separate to the pelvic floor. While transanal total mesorectal excision&#xD;
      (TaTME) approach could be more directly separate the low mesorectum and relatively simple to&#xD;
      complete distal rectal transection, which would bring some considerable advantages. Although&#xD;
      active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in&#xD;
      China. It is urgent for clinical studies to obtain the results in China. This multicenter,&#xD;
      observational study will help to encourage research in this field and to obtain data on the&#xD;
      safety and efficacy of this procedure in Chinese patients with rectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Positive rate of circumferential resection margin (CRM) of the specimens</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while &gt;1mm is negative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The grade score of the specimens integrity</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see &gt;5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The distance between lower tumor margin and the lower reaction margin</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local recurrence rate</measure>
    <time_frame>3 years after surgery</time_frame>
    <description>show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the operative time</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>preoperative safety containing operation information, complication information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative hospital stay</measure>
    <time_frame>3 year after surgery</time_frame>
    <description>recovery information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score of postoperative life</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease free survival rate</measure>
    <time_frame>3-year after surgery</time_frame>
    <description>show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival rate</measure>
    <time_frame>3-year after surgery</time_frame>
    <description>show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of postoperative complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>preoperative safety containing operation information, complication information.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Rectal Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        lower rectal cancer patients who are suitable and willing to accept laparoscopy- assisted&#xD;
        TME procedure and also agree with the trial&#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;
          -  the lower edge of the tumor from the anal margin less than 10cm according to MRI or&#xD;
             rigid endoscopy&#xD;
&#xD;
          -  tumor diameter less than 4cm&#xD;
&#xD;
          -  baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)&#xD;
&#xD;
          -  tolerable to surgery&#xD;
&#xD;
          -  be able to understand and willing to participate in this trial with signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of malignant colorectal neoplasia&#xD;
&#xD;
          -  recent diagnosis with other malignancies&#xD;
&#xD;
          -  patients requiring emergency surgery such as obstruction，perforation and bleeding&#xD;
&#xD;
          -  tumor involving adjacent organs, anal sphincter, or levator ani muscle&#xD;
&#xD;
          -  muti-focal colorectal cancer&#xD;
&#xD;
          -  preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence&#xD;
&#xD;
          -  history of inflammatory bowel disease or familial adenomatous polyposis&#xD;
&#xD;
          -  participating in other clinical trails&#xD;
&#xD;
          -  can not tolerate the surgery&#xD;
&#xD;
          -  history of serious mental illness&#xD;
&#xD;
          -  pregnancy or lactating women&#xD;
&#xD;
          -  preoperative uncontrolled infection&#xD;
&#xD;
          -  the researchers believe the patients should not enrolled in&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</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>assistant dean, professor</investigator_title>
  </responsible_party>
  <keyword>transanal surgery</keyword>
  <keyword>total mesorectal excision</keyword>
  <keyword>rectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</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/NCT03253302
org study id: CR-TaTME
nct id: NCT03253302
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
At present, surgical resection is still the main treatment for the potential cure of rectal
      cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or
      open surgery for some special patients is really difficult, especially for male, prostate
      hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the
      mesorectum and separate to the pelvic floor. While transanal total mesorectal excision
      (TaTME) approach could be more directly separate the low mesorectum and relatively simple to
      complete distal rectal transection, which would bring some considerable advantages. Although
      active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in
      China. It is urgent for clinical studies to obtain the results in China. This multicenter,
      observational study will help to encourage research in this field and to obtain data on the
      safety and efficacy of this procedure in Chinese patients with rectal cancer.
observational model: Case-Only
time perspective: Prospective
measure: Positive rate of circumferential resection margin (CRM) of the specimens
time frame: 10 days after surgery
description: Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
measure: The grade score of the specimens integrity
time frame: 10 days after surgery
description: shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
measure: The distance between lower tumor margin and the lower reaction margin
time frame: 10 days after surgery
description: shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
measure: local recurrence rate
time frame: 3 years after surgery
description: show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
measure: the operative time
time frame: 30 days after surgery
description: preoperative safety containing operation information, complication information.
measure: postoperative hospital stay
time frame: 3 year after surgery
description: recovery information.
measure: the score of postoperative life
time frame: 6 months after surgery
description: quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.
measure: disease free survival rate
time frame: 3-year after surgery
description: show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
measure: overall survival rate
time frame: 3-year after surgery
description: show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
measure: the rate of postoperative complications
time frame: 30 days after surgery
description: preoperative safety containing operation information, complication information.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Zhongtao Zhang
investigator title: assistant dean, professor
mesh term: Rectal Neoplasms