<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/NCT02252250</url>
  </required_header>
  <id_info>
    <org_study_id>20141056</org_study_id>
    <nct_id>NCT02252250</nct_id>
  </id_info>
  <brief_title>Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer</brief_title>
  <official_title>A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigates the feasibility, practicability, safety and subjective as well as functional&#xD;
      outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce&#xD;
      surgical access trauma leading to a more painless surgery and enhancing a fast postoperative&#xD;
      recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show&#xD;
      that such NOTES procedures are feasible and safe. And also, lots of experimental studies and&#xD;
      small case series reporting the feasibility of transanal anterior resection with single&#xD;
      incision laparoscopic surgery(SILS) port or other devices. However any prospective&#xD;
      feasibility study demonstrating the safety of the procedure and functional outcomes&#xD;
      (sphincter function, sexual function, QOF) are missing. This study investigates the&#xD;
      feasibility, practicability, safety and subjective as well as functional outcome of transanal&#xD;
      minimal invasive total mesentery excision for rectal cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.</measure>
    <time_frame>1-6 years</time_frame>
    <description>Lymph nodes number; rate of positive circumferential resection margin(CRM);</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of 30-day perioperative complications including intraoperative, and postoperative complications</measure>
    <time_frame>0-30 days</time_frame>
    <description>bleeding, injury of adjacent organs, ileus, leakage, infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of long-term complications</measure>
    <time_frame>1-6 years</time_frame>
    <description>incision hernia,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.</measure>
    <time_frame>1-6 years</time_frame>
    <description>overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>defecating functional outcomes</measure>
    <time_frame>1-6 years</time_frame>
    <description>constipation score and incontinence score</description>
  </other_outcome>
  <other_outcome>
    <measure>sexual functional outcomes</measure>
    <time_frame>1-6 years</time_frame>
    <description>We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life outcomes evaluation</measure>
    <time_frame>1-6 years</time_frame>
    <description>We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) .</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Rectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>conventional laparoscopic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional laparoscopic total mesentery excision surgery for rectal cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transanal hybrid-laparoscopic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional laparoscopic total mesentery excision</intervention_name>
    <description>conventional laparoscopic total mesentery excision</description>
    <arm_group_label>conventional laparoscopic</arm_group_label>
    <other_name>LTME</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transanal hybrid-laparoscopic total mesentery excision</intervention_name>
    <description>transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.</description>
    <arm_group_label>Transanal hybrid-laparoscopic</arm_group_label>
    <other_name>TLTME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy-proven adenocarcinoma of the rectum&#xD;
&#xD;
          -  Eligible to undergo conventional laparoscopic low anterior resection or transanal&#xD;
             hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma&#xD;
&#xD;
          -  Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI&#xD;
&#xD;
          -  Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic&#xD;
             MRI&#xD;
&#xD;
          -  Rectal cancer located 3-10 cm from the anal verge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastasis&#xD;
&#xD;
          -  Obstructing rectal cancer&#xD;
&#xD;
          -  Synchronous colon cancer&#xD;
&#xD;
          -  T4 rectal cancer not treated preoperatively with full-course chemoradiation&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Receiving any other study agents&#xD;
&#xD;
          -  Fecal incontinence&#xD;
&#xD;
          -  History of prior colorectal cancer&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  History of pelvic radiation&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Large uterine fibroids&#xD;
&#xD;
          -  Uncontrolled intercurrent illness&#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>Weidong Tong, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daping Hospital, Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weidong Tong, Prof</last_name>
    <phone>86-023-68757956</phone>
    <email>tongweidong@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Weidong Tong, Prof</last_name>
    <phone>86-13500321218</phone>
    <email>vdtong@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Daping hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weidong Tong, Prof</last_name>
      <phone>86-023-68757956</phone>
      <email>tongweidong@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Weidong Tong, Prof</last_name>
      <phone>86-13500321218</phone>
      <email>vdtong@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>April 24, 2022</last_update_submitted>
  <last_update_submitted_qc>April 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 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>Dr</investigator_title>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>laparoscopic</keyword>
  <keyword>taTME</keyword>
  <keyword>TME</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/NCT02252250
org study id: 20141056
nct id: NCT02252250
lead sponsor: 
has dmc: Yes
To investigates the feasibility, practicability, safety and subjective as well as functional
      outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce
      surgical access trauma leading to a more painless surgery and enhancing a fast postoperative
      recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show
      that such NOTES procedures are feasible and safe. And also, lots of experimental studies and
      small case series reporting the feasibility of transanal anterior resection with single
      incision laparoscopic surgery(SILS) port or other devices. However any prospective
      feasibility study demonstrating the safety of the procedure and functional outcomes
      (sphincter function, sexual function, QOF) are missing. This study investigates the
      feasibility, practicability, safety and subjective as well as functional outcome of transanal
      minimal invasive total mesentery excision for rectal cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
time frame: 1-6 years
description: Lymph nodes number; rate of positive circumferential resection margin(CRM);
measure: Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
time frame: 0-30 days
description: bleeding, injury of adjacent organs, ileus, leakage, infection
measure: Incidence of long-term complications
time frame: 1-6 years
description: incision hernia,
measure: Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
time frame: 1-6 years
description: overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate
measure: defecating functional outcomes
time frame: 1-6 years
description: constipation score and incontinence score
measure: sexual functional outcomes
time frame: 1-6 years
description: We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF)
measure: Quality of life outcomes evaluation
time frame: 1-6 years
description: We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) .
arm group label: conventional laparoscopic
arm group type: Active Comparator
description: conventional laparoscopic total mesentery excision surgery for rectal cancer.
arm group label: Transanal hybrid-laparoscopic
arm group type: Experimental
description: Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.
intervention type: Procedure
intervention name: conventional laparoscopic total mesentery excision
description: conventional laparoscopic total mesentery excision
arm group label: conventional laparoscopic
other name: LTME
intervention type: Procedure
intervention name: transanal hybrid-laparoscopic total mesentery excision
description: transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.
arm group label: Transanal hybrid-laparoscopic
other name: TLTME
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Weidong Tong, Prof
role: Principal Investigator
affiliation: Daping Hospital, Third Military Medical University
last name: Weidong Tong, Prof
phone: 86-023-68757956
email: tongweidong@gmail.com
last name: Weidong Tong, Prof
phone: 86-13500321218
email: vdtong@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Weidong Tong
investigator title: Dr
mesh term: Rectal Neoplasms