<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/NCT02236884</url>
  </required_header>
  <id_info>
    <org_study_id>GIHSYSU08</org_study_id>
    <secondary_id>D2014002</secondary_id>
    <nct_id>NCT02236884</nct_id>
  </id_info>
  <brief_title>The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer</brief_title>
  <official_title>A Pilot Study of the Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer Without Conventional Laparoscopic Assistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the past three years, a revolutionized radical surgical approach for rectal cancer&#xD;
      (&quot;down to up TME &quot; approach or &quot;transanal TME (TaTME)&quot;approach, which is opposite to the&#xD;
      conventional approach) has emerged and it is a concept that combines natural orifice&#xD;
      transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative&#xD;
      intent. The feasibility, safety and reproducibility of it were first demonstrated in swine&#xD;
      survival experiments and subsequently in human cadaver series, and then it was successfully&#xD;
      applied to human patients in few centers around the world, most of which were performed with&#xD;
      assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without&#xD;
      conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases&#xD;
      were more limited. In the initial stage, our group has successfully performed this no-scar&#xD;
      transanal TME in a series of human cadavers with satisfactory outcome. Hence the&#xD;
      investigators conduct this study, looking to see if this pure transanal NOTES investigational&#xD;
      procedure is a safe and effective approach to radically remove rectal cancer of the mid and&#xD;
      lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function&#xD;
      and life quality when gaining the best cosmetic effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transanal total mesorectal excision (TaTME) is a novel development in the field of colorectal&#xD;
      surgery which combines the mini-invasive concept of natural orifice transluminal endoscopic&#xD;
      surgery(NOTES), the technique of single-port laparoscopic surgery and the principle of total&#xD;
      mesorectal excision with curative intent for treating rectal cancer. Based on the platform of&#xD;
      either transanal endoscopic microsurgery(TEM) or transanal minimally invasive surgery&#xD;
      (TAMIS), it is an innovative way of retrograde TME dissection from bottom to up with or&#xD;
      without laparoscopic assistance. It is supposed to facilitate distal rectal mobilization,&#xD;
      thus achieving precise and sufficient distal margin and to reduced need for multiple stapler&#xD;
      firings in transecting the rectum, consequently decreasing anastomotic leakage rates which is&#xD;
      especially important for obese male patients with a narrow pelvis where exposure to the&#xD;
      distal rectum from the abdominal approach can prove difficult. It could also protect&#xD;
      neurovascular bundle with better visualization and exposure and has the advantage of better&#xD;
      function and avoiding sacrificing sphincter. After a series of preclinical trail of animal&#xD;
      and cadaver, it has been successfully applied to humans and successional reports have proved&#xD;
      its feasibility and safety. However, the majority of published series is hybrid NOTES, which&#xD;
      need the assistance of conventional laparoscopic surgery from above to bottom and abdominal&#xD;
      incision, scar, pain and incision related complications such as wound infection, abscess,&#xD;
      hernia and implanted incisional tumors cannot be necessary avoided. It is also worried that&#xD;
      the cost will increased since two groups of surgical equipment are needed(the abdominal and&#xD;
      perineal) and more surgical staff are required if the two team operate at the same&#xD;
      time(two-team approach). Up to date, as far as we have known, the pure transanal TME NOTES&#xD;
      without any laparoscopic assistance has also been successfully performed in human patients&#xD;
      though the cases are rare. The investigators of our center have also successfully performed&#xD;
      pure-NOTES rectal resection in human cadavers in the past few months, and are confident to&#xD;
      move this forward to conduct this pilot study to evaluate the feasibility and safety of this&#xD;
      surgery in rectal cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite mesure of prioperative feasibility and safety</measure>
    <time_frame>one-year</time_frame>
    <description>To evaluate the feasibility and safety by operative time, estimated blood loss, intraoperative complications, convert to Hybrid NOTES or open surgery, pathological outcome including Total Mesorectal Excision (TME) quality, the lymph nodes harvested, and specimen length, circumferential margin, etc. and postoperative complications graded according to Clavien-Dindo, reoperation rate, 30-day mortality, 30-day readmission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>composite measure of life quality</measure>
    <time_frame>1-3 year</time_frame>
    <description>To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite mesure of postoperative outcome</measure>
    <time_frame>one-year</time_frame>
    <description>To evaluate the postoperative outcome by length of hospital stay after operation, the time of first flatus, the time of recover to flow diet, postoperative pain by VAS, analgesic use ,etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite mesure of oncological outcome</measure>
    <time_frame>1-3 year</time_frame>
    <description>3-year disease free survival (DFS), 3-year local recurrence rate, 3-year distal metastasis rate, 3-year overall survival (cancer related or non-cancer related)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Rectal Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>no-scar transanal TME</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no-scar transanal total mesorectal excision(TME) of rectal cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>no-scar transanal total mesorectal excision(TME)</intervention_name>
    <arm_group_label>no-scar transanal TME</arm_group_label>
    <other_name>Pure NOTES transanal TME</other_name>
    <other_name>TaTME</other_name>
    <other_name>TAMIS TME</other_name>
    <other_name>single-port transanal TME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy-proven adenocarcinoma of the rectum&#xD;
&#xD;
          -  No previous abdominal surgery, no distant metastasis or synchronous colon cancer&#xD;
&#xD;
          -  BMI≤ 35kg/m2&#xD;
&#xD;
          -  Clinical staging (T1 or T2 or T3) with N1-2M0&#xD;
&#xD;
          -  Patients of rectal adenocarcinoma with T3N0 or N (+) received preoperative concurrent&#xD;
             chemoradiotherapy (CCRT) as neoadjuvant therapy&#xD;
&#xD;
          -  Rectal cancer located 4-12 cm from the anal verge&#xD;
&#xD;
          -  The diameter of primary tumor should &lt;6cm&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of&#xD;
             0 or 1&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) classⅠ to Ⅲ lesions&#xD;
&#xD;
          -  After the evaluation of Multi-disciplinary team (MDT)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T4 tumor that invade the external sphincter or levator ani muscle or neighbor organs&#xD;
&#xD;
          -  Recurrent rectal cancer&#xD;
&#xD;
          -  Distant metastasis&#xD;
&#xD;
          -  Obstructing rectal cancer&#xD;
&#xD;
          -  Synchronous colon cancer&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Fecal incontinence&#xD;
&#xD;
          -  History of prior colorectal cancer&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Other malignancies diagnosed within the previous year&#xD;
&#xD;
          -  Mental illness&#xD;
&#xD;
          -  Any evidence of active infection&#xD;
&#xD;
          -  History of bleeding diathesis or coagulopathy&#xD;
&#xD;
          -  Impaired renal or hepatic function that could not tolerate surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianping Wang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sun Yatsen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastrointestinal Hospital, Sun Yatsen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29.</citation>
    <PMID>26220109</PMID>
  </reference>
  <results_reference>
    <citation>Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.</citation>
    <PMID>26310534</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yanhong Deng</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>no scar</keyword>
  <keyword>NOTES</keyword>
  <keyword>TaTME</keyword>
  <keyword>feasibility</keyword>
  <keyword>safety</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/NCT02236884
org study id: GIHSYSU08
secondary id: D2014002
nct id: NCT02236884
lead sponsor: 
has dmc: Yes
During the past three years, a revolutionized radical surgical approach for rectal cancer
      ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the
      conventional approach) has emerged and it is a concept that combines natural orifice
      transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative
      intent. The feasibility, safety and reproducibility of it were first demonstrated in swine
      survival experiments and subsequently in human cadaver series, and then it was successfully
      applied to human patients in few centers around the world, most of which were performed with
      assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without
      conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases
      were more limited. In the initial stage, our group has successfully performed this no-scar
      transanal TME in a series of human cadavers with satisfactory outcome. Hence the
      investigators conduct this study, looking to see if this pure transanal NOTES investigational
      procedure is a safe and effective approach to radically remove rectal cancer of the mid and
      lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function
      and life quality when gaining the best cosmetic effect.
Transanal total mesorectal excision (TaTME) is a novel development in the field of colorectal
      surgery which combines the mini-invasive concept of natural orifice transluminal endoscopic
      surgery(NOTES), the technique of single-port laparoscopic surgery and the principle of total
      mesorectal excision with curative intent for treating rectal cancer. Based on the platform of
      either transanal endoscopic microsurgery(TEM) or transanal minimally invasive surgery
      (TAMIS), it is an innovative way of retrograde TME dissection from bottom to up with or
      without laparoscopic assistance. It is supposed to facilitate distal rectal mobilization,
      thus achieving precise and sufficient distal margin and to reduced need for multiple stapler
      firings in transecting the rectum, consequently decreasing anastomotic leakage rates which is
      especially important for obese male patients with a narrow pelvis where exposure to the
      distal rectum from the abdominal approach can prove difficult. It could also protect
      neurovascular bundle with better visualization and exposure and has the advantage of better
      function and avoiding sacrificing sphincter. After a series of preclinical trail of animal
      and cadaver, it has been successfully applied to humans and successional reports have proved
      its feasibility and safety. However, the majority of published series is hybrid NOTES, which
      need the assistance of conventional laparoscopic surgery from above to bottom and abdominal
      incision, scar, pain and incision related complications such as wound infection, abscess,
      hernia and implanted incisional tumors cannot be necessary avoided. It is also worried that
      the cost will increased since two groups of surgical equipment are needed(the abdominal and
      perineal) and more surgical staff are required if the two team operate at the same
      time(two-team approach). Up to date, as far as we have known, the pure transanal TME NOTES
      without any laparoscopic assistance has also been successfully performed in human patients
      though the cases are rare. The investigators of our center have also successfully performed
      pure-NOTES rectal resection in human cadavers in the past few months, and are confident to
      move this forward to conduct this pilot study to evaluate the feasibility and safety of this
      surgery in rectal cancer patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite mesure of prioperative feasibility and safety
time frame: one-year
description: To evaluate the feasibility and safety by operative time, estimated blood loss, intraoperative complications, convert to Hybrid NOTES or open surgery, pathological outcome including Total Mesorectal Excision (TME) quality, the lymph nodes harvested, and specimen length, circumferential margin, etc. and postoperative complications graded according to Clavien-Dindo, reoperation rate, 30-day mortality, 30-day readmission
measure: composite measure of life quality
time frame: 1-3 year
description: To evaluate bladder function, anal function, sexual function and life quality by incontinence score, EORTC QLQ C30 and EORTC QLQ CR38, etc
measure: Composite mesure of postoperative outcome
time frame: one-year
description: To evaluate the postoperative outcome by length of hospital stay after operation, the time of first flatus, the time of recover to flow diet, postoperative pain by VAS, analgesic use ,etc
measure: Composite mesure of oncological outcome
time frame: 1-3 year
description: 3-year disease free survival (DFS), 3-year local recurrence rate, 3-year distal metastasis rate, 3-year overall survival (cancer related or non-cancer related)
arm group label: no-scar transanal TME
arm group type: Experimental
description: no-scar transanal total mesorectal excision(TME) of rectal cancer
intervention type: Procedure
intervention name: no-scar transanal total mesorectal excision(TME)
arm group label: no-scar transanal TME
other name: Pure NOTES transanal TME
other name: TaTME
other name: TAMIS TME
other name: single-port transanal TME
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jianping Wang, MD
role: Study Director
affiliation: Sun Yatsen University
facility: 
country: China
citation: Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29.
PMID: 26220109
citation: Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.
PMID: 26310534
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Yanhong Deng
investigator title: doctor
mesh term: Rectal Neoplasms