<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/NCT02966483</url>
  </required_header>
  <id_info>
    <org_study_id>SYSU-RECTAl-2016</org_study_id>
    <nct_id>NCT02966483</nct_id>
  </id_info>
  <brief_title>Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer</brief_title>
  <official_title>Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College 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>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shengjing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second People's Hospital of Yibin</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>Nanchong Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of University of South China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinqiao Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Guangdong Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior&#xD;
      alternative regarding resection quality, and oncological outcomes of patients as compared to&#xD;
      open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over&#xD;
      open surgery with regard to operative invasiveness, patient's recovery, and wound related&#xD;
      complications. Thus, laparoscopic surgery has gained great popularity over the past decades.&#xD;
      However, specifically for mid and low rectal cancer, laparoscopic surgery is technically&#xD;
      demanding, which sometimes leads to high morbidity and unsatisfactory resection quality,&#xD;
      especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated&#xD;
      pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so&#xD;
      called &quot;down-to-up&quot; alternative, has emerged as a promising solution to these problems in&#xD;
      recent years and more and more small studies have proven the feasibility and advantages of&#xD;
      this technique, making it become a hot topic among both literature and conferences. However,&#xD;
      TaTME is still at early birth, higher-level evidences, either multicentric, or comparative&#xD;
      study with conventional surgery is strikingly lacking. Thus the investigators conduct this&#xD;
      multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for&#xD;
      mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better&#xD;
      resection quality and result in non-inferior oncological outcome, as well as short term&#xD;
      operative morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising&#xD;
      surgical alternative for rectal cancer, especially for mid and low rectal cancer.&#xD;
      Theoretically, TaTME holds the potential advantage of providing better access to mobilize the&#xD;
      distal rectum, and thus could achieve better pathologic outcomes, such as lower involved&#xD;
      circumferential margin (CRM) and incomplete resected mesorectum, which could translate into&#xD;
      better oncological outcome for the patients in the long term. However, until now, the&#xD;
      feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision,&#xD;
      LpTME) of this technique has only been validated in studies with limitations of small sample&#xD;
      size, retrospective nature.&#xD;
&#xD;
      Study Objective:This study aims to evaluate the TaTME technique compared with conventional&#xD;
      laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival&#xD;
      results.&#xD;
&#xD;
      Study design This study is a prospective, multi-center, randomized, open-label, parallel&#xD;
      group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic&#xD;
      data capture (EDC) system will be utilized for randomization, electronic CRF and data&#xD;
      collection. All comparative analyses will be conducted on an &quot;intention to treat&quot; basis.&#xD;
&#xD;
      Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the&#xD;
      sample size according to 5-year OS was larger than that based on 3-year DFS. The expected&#xD;
      5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%.&#xD;
      Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to&#xD;
      sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an&#xD;
      α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a&#xD;
      total of 1114 patients were planned to enroll for this trial.&#xD;
&#xD;
      Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS)&#xD;
      rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection&#xD;
      quality, mainly including circumferential involvement rate, and completeness of mesorectum.&#xD;
      Resected specimen was pathologically processed and assessed at each center by trained and&#xD;
      qualified pathologists independently.2)short term operative results such as morbidity and&#xD;
      mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall&#xD;
      survival. Besides, functional outcome and quality of life are also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Disease-free survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>Overall survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive circumferential resection margin (CRM)</measure>
    <time_frame>3 years</time_frame>
    <description>Involved CRM (tumor cells &lt;1mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>10 years</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesorectal completeness</measure>
    <time_frame>3 years</time_frame>
    <description>The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of retrieved lymph nodes</measure>
    <time_frame>3 years</time_frame>
    <description>Number of retrieved lymph nodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate</measure>
    <time_frame>1 years</time_frame>
    <description>Morbidity rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>1 years</time_frame>
    <description>Mortality rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anorectal function outcomes</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate defecating function with Wexner score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual functional outcomes</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The patient's Quality of life: EORTC QLQ-30 questionnaire</measure>
    <time_frame>3 years</time_frame>
    <description>To evaluate quality of life with EORTC QLQ-30 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1114</enrollment>
  <condition>Rectal Neoplasms Malignant</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Transanal Total Mesorectal Excision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Total Mesorectal Excision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TaTME</intervention_name>
    <description>Transanal Total Mesorectal Excision</description>
    <arm_group_label>Transanal Total Mesorectal Excision</arm_group_label>
    <other_name>Transanal TME</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LpTME</intervention_name>
    <description>Conventional Laparoscopic Total Mesorectal Excision</description>
    <arm_group_label>Laparoscopic Total Mesorectal Excision</arm_group_label>
    <other_name>Laparoscopic TME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        histologically proven rectal adenocarcinoma;&#xD;
&#xD;
        tumor located below the level of peritoneal reflection ;&#xD;
&#xD;
        diagnosis of rectal cancer amenable to curative surgery;&#xD;
&#xD;
        no evidence of distant metastases;&#xD;
&#xD;
        preoperative tumor stage within III;&#xD;
&#xD;
        no threaten mesorectal fascia (MRF)after neoadjuvant therapy;&#xD;
&#xD;
        no contraindication to laparoscopic surgery;&#xD;
&#xD;
        without history of other malignancies;&#xD;
&#xD;
        Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        could not perform sphincter preservation surgery (requiring a Mile's procedure);&#xD;
&#xD;
        T4b tumor invading adjacent organs;&#xD;
&#xD;
        T1 tumors that can be locally resected&#xD;
&#xD;
        should take neoadjuvant therapy but refuse it;&#xD;
&#xD;
        recurrent cancer;&#xD;
&#xD;
        concurrent or previous diagnosis of invasive cancer within 5 years;&#xD;
&#xD;
        emergent surgery with intestinal obstruction or perforation;&#xD;
&#xD;
        history of colorectal surgery;&#xD;
&#xD;
        fecal incontinence;&#xD;
&#xD;
        history of inflammatory bowel disease;&#xD;
&#xD;
        with contraindications to general anaesthesia(ASA class 4 or 5);&#xD;
&#xD;
        pregnant or breast-feeding;&#xD;
&#xD;
        history of mental disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianping Wang, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>the Sixth Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liang Kang, MD,PHD</last_name>
    <phone>008613602886833</phone>
    <email>eonkang@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Xiao, MD, PhD</last_name>
      <phone>008613366036387</phone>
      <email>XiaoY@pumch.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery, Daping Hospital, Army Medical university</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weidong Tong, MD, PhD</last_name>
      <phone>008613500321218</phone>
      <email>vdtong@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Kang, MD, PhD</last_name>
      <phone>008613602886833</phone>
      <email>eonkang@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510559</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanan Wang, MD.PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Guangdong Medical University</name>
      <address>
        <city>Zhanjiang</city>
        <state>Guangdong</state>
        <zip>524001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingwen Xu, MD</last_name>
      <phone>008613600387083</phone>
      <email>xuqwen@21cn.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Zunyi Medical University</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>563003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Xie, MD</last_name>
      <phone>008615519202000</phone>
      <email>2581303091@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Zhang, MD,PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of University of South China</name>
      <address>
        <city>Hengyang</city>
        <state>Hunan</state>
        <zip>421001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Ouyang, MD</last_name>
      <phone>008613973426200</phone>
      <email>1847039906@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Gastrointestinal Surgery, The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quan Wang, MD,PhD</last_name>
      <phone>008615843073207</phone>
      <email>wangquanjdyy@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Colorectal Surgery, Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Zhang, MD</last_name>
      <phone>008618940257919</phone>
      <email>haojiubujian1203@sina.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongchun Song, MD</last_name>
      <phone>008618991232549</phone>
      <email>dr.songyongchun@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo Feng, MD,PhD</last_name>
      <phone>008613512103996</phone>
      <email>fengbo2022@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qing Xu, MD, PhD</last_name>
      <phone>008613761002053</phone>
      <email>renjixuqing@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Gastrointestinal Surgery，The Affiliated Nanchong Central Hospital of North Sichuan Medical College</name>
      <address>
        <city>Nanchong</city>
        <state>Sichuan</state>
        <zip>637000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mingyang Ren, MD</last_name>
      <phone>008613890756</phone>
      <email>2861746489@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of gastrointestinal surgery, the Second People's Hospital of Yibin</name>
      <address>
        <city>Yibin</city>
        <state>Sichuan</state>
        <zip>644000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miao Wu, MD</last_name>
      <phone>008613990905852</phone>
      <email>13990905852@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>XinQiao Hospital of Army Medical University</name>
      <address>
        <city>Chongqing</city>
        <zip>400037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dan Ma, MD,Phd</last_name>
      <phone>008615823555665</phone>
      <email>1054727918@qq.com</email>
    </contact>
  </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>
  <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>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</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>MD</investigator_title>
  </responsible_party>
  <keyword>Rectal cancer</keyword>
  <keyword>Laparoscopic surgery</keyword>
  <keyword>Total mesorectal excision</keyword>
  <keyword>Transanal</keyword>
  <keyword>Multicentre randomised clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02966483
org study id: SYSU-RECTAl-2016
nct id: NCT02966483
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is fda regulated device: No
Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior
      alternative regarding resection quality, and oncological outcomes of patients as compared to
      open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over
      open surgery with regard to operative invasiveness, patient's recovery, and wound related
      complications. Thus, laparoscopic surgery has gained great popularity over the past decades.
      However, specifically for mid and low rectal cancer, laparoscopic surgery is technically
      demanding, which sometimes leads to high morbidity and unsatisfactory resection quality,
      especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated
      pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so
      called "down-to-up" alternative, has emerged as a promising solution to these problems in
      recent years and more and more small studies have proven the feasibility and advantages of
      this technique, making it become a hot topic among both literature and conferences. However,
      TaTME is still at early birth, higher-level evidences, either multicentric, or comparative
      study with conventional surgery is strikingly lacking. Thus the investigators conduct this
      multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for
      mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better
      resection quality and result in non-inferior oncological outcome, as well as short term
      operative morbidity and mortality.
Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising
      surgical alternative for rectal cancer, especially for mid and low rectal cancer.
      Theoretically, TaTME holds the potential advantage of providing better access to mobilize the
      distal rectum, and thus could achieve better pathologic outcomes, such as lower involved
      circumferential margin (CRM) and incomplete resected mesorectum, which could translate into
      better oncological outcome for the patients in the long term. However, until now, the
      feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision,
      LpTME) of this technique has only been validated in studies with limitations of small sample
      size, retrospective nature.

      Study Objective:This study aims to evaluate the TaTME technique compared with conventional
      laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival
      results.

      Study design This study is a prospective, multi-center, randomized, open-label, parallel
      group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic
      data capture (EDC) system will be utilized for randomization, electronic CRF and data
      collection. All comparative analyses will be conducted on an "intention to treat" basis.

      Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the
      sample size according to 5-year OS was larger than that based on 3-year DFS. The expected
      5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%.
      Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to
      sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an
      α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a
      total of 1114 patients were planned to enroll for this trial.

      Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS)
      rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection
      quality, mainly including circumferential involvement rate, and completeness of mesorectum.
      Resected specimen was pathologically processed and assessed at each center by trained and
      qualified pathologists independently.2)short term operative results such as morbidity and
      mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall
      survival. Besides, functional outcome and quality of life are also evaluated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: 3 years
description: Disease-free survival
measure: Overall survival
time frame: 5 years
description: Overall survival
measure: Positive circumferential resection margin (CRM)
time frame: 3 years
description: Involved CRM (tumor cells <1mm)
measure: Overall survival
time frame: 10 years
description: Overall survival
measure: Mesorectal completeness
time frame: 3 years
description: The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
measure: Number of retrieved lymph nodes
time frame: 3 years
description: Number of retrieved lymph nodes
measure: Morbidity rate
time frame: 1 years
description: Morbidity rate
measure: Mortality rate
time frame: 1 years
description: Mortality rate
measure: Anorectal function outcomes
time frame: 3 years
description: To evaluate defecating function with Wexner score
measure: Sexual functional outcomes
time frame: 3 years
description: To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
measure: The patient's Quality of life: EORTC QLQ-30 questionnaire
time frame: 3 years
description: To evaluate quality of life with EORTC QLQ-30 questionnaire
arm group label: Transanal Total Mesorectal Excision
arm group type: Experimental
description: The rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below.
arm group label: Laparoscopic Total Mesorectal Excision
arm group type: Active Comparator
description: The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments.
intervention type: Procedure
intervention name: TaTME
description: Transanal Total Mesorectal Excision
arm group label: Transanal Total Mesorectal Excision
other name: Transanal TME
intervention type: Procedure
intervention name: LpTME
description: Conventional Laparoscopic Total Mesorectal Excision
arm group label: Laparoscopic Total Mesorectal Excision
other name: Laparoscopic TME
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianping Wang, MD,PHD
role: Principal Investigator
affiliation: the Sixth Affiliated Hospital, Sun Yat-Sen University
last name: Liang Kang, MD,PHD
phone: 008613602886833
email: eonkang@163.com
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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: MD
mesh term: Rectal Neoplasms
mesh term: Neoplasms
sharing ipd: Undecided