<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/NCT03242187</url>
  </required_header>
  <id_info>
    <org_study_id>MansTaTME/17.04.84</org_study_id>
    <nct_id>NCT03242187</nct_id>
  </id_info>
  <brief_title>Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer</brief_title>
  <acronym>MansTaTME</acronym>
  <official_title>(MansTaTME) Trans-anal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      This study is designed to assess the surgical, oncological and functional outcome of either&#xD;
      the laparoscopic or trans-anal TME in management of mid and low rectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer (CRC) is considered the third most common type of cancer all over the world&#xD;
      and the fourth common cause of cancer-specific mortality.Surgical management for rectal&#xD;
      cancer is challenging due to the narrow pelvis and extreme proximity to contiguous organs&#xD;
      hence, recurrence rates are commonly reported.&#xD;
&#xD;
      The advent of total mesorectal excision (TME) together with minimally invasive techniques&#xD;
      such as laparoscopic colorectal surgery have not only improved surgical results but have also&#xD;
      improved surgical technique, operative ability and surgical visibility. Lap TME has been&#xD;
      shown to give similar results to the classical open approach with regard to peri-operative&#xD;
      morbidity, surgical margins, quality of the surgical specimen, and number of resected lymph&#xD;
      nodes, local recurrence and overall survival.&#xD;
&#xD;
      However, laparoscopic resection of mid and low rectal cancer is technically difficult due to&#xD;
      tapering of the mesorectum in the pelvis and the forward angle of the distal rectum rendering&#xD;
      this part of the rectum less accessible from the abdominal cavity. This may lead to&#xD;
      incomplete mesorectal excision and involved circumferential resection margins (CRMs), with&#xD;
      consequent local recurrences.Previous pelvic radiation can make laparoscopic pelvic&#xD;
      dissection more difficult, and tumors located on the anterior rectal wall have an increased&#xD;
      risk of inadequate oncological clearance. The use of laparoscopic staplers in a narrow pelvis&#xD;
      is difficult and the multiple firings of staples across the low rectum is of concern.&#xD;
&#xD;
      Trans-anal Total Mesorectal Excision (TaTME) was recently developed to overcome technical&#xD;
      difficulties associated with Lap TME and open TME. It may address some of the difficult&#xD;
      aspects of laparoscopic or open TME, such as exposure, rectal dissection, and distal&#xD;
      cross-stapling of the rectum and sphincter preservation. It does not only facilitate&#xD;
      dissection of the difficult distal part of the TME dissection in the narrow pelvis but it&#xD;
      also allows clear definition of safe, tumor-free, radial and longitudinal margins. Moreover,&#xD;
      the specimen could be extracted through the anus excluding the need for minilaparotmy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 25, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Circumferential radial margin (CRM)</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of participants with involved circumferential margin(pathological assessment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distal safety margin</measure>
    <time_frame>2 years</time_frame>
    <description>Distance of free distal margin in mm (pathological assessment)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of lymph nodes retrieved</measure>
    <time_frame>2 years</time_frame>
    <description>Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate</measure>
    <time_frame>2 years</time_frame>
    <description>Number of intra-operative and post-operative encountered complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of conversion</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>30 months</time_frame>
    <description>Time till development of local or distant recurrence in months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>18 months</time_frame>
    <description>Assessment of functional outcome via questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Trans-anal TME (TaTME)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lap. TME</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trans-anal total mesorectal excision(TaTME)</intervention_name>
    <description>Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)</description>
    <arm_group_label>Trans-anal TME (TaTME)</arm_group_label>
    <other_name>Bottom to up approach</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lap. TME</intervention_name>
    <description>Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection</description>
    <arm_group_label>Lap. TME</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Anesthetically fit patient.&#xD;
&#xD;
          2. Non metastatic pathologically proven rectal cancer (Mid-Low).&#xD;
&#xD;
          3. Patients who received neoadjuvant chemo-radiotherapy will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.&#xD;
&#xD;
          2. Patients with cardiac or chest problems that cannot withstand CO2 insufflation.&#xD;
&#xD;
          3. Unresectable tumors (T4) (defined as those who cannot be resected without a high&#xD;
             likelihood of leaving microscopic or gross residual disease at the local site because&#xD;
             of tumor adherence or fixation).&#xD;
&#xD;
          4. Obstructed or perforated cancer.&#xD;
&#xD;
          5. Patients with unresectable metastatic rectal cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammad Z Metwally, Ass.Lecturer</last_name>
    <phone>00201068683363</phone>
    <email>mohammadzuhdy@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sameh R Abdelazeez, Professor</last_name>
    <email>samehroshdy20@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oncology Center, Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Z Metwally, Ass.Lecturer</last_name>
      <phone>00201068683363</phone>
      <email>mohammadzuhdy@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sameh R Abdelaziz, Professor</last_name>
      <email>samehroshdy20@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.</citation>
    <PMID>24225001</PMID>
  </reference>
  <reference>
    <citation>Vennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;(4):CD005200. doi: 10.1002/14651858.CD005200.pub3.</citation>
    <PMID>24737031</PMID>
  </reference>
  <reference>
    <citation>Qu C, Yuan RF, Huang J, Liu L, Jiang CH, Yang ZQ, Shao JH. [Meta-analysis of laparoscopic versus open total mesorectal excision for middle and low rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Aug;16(8):748-52. Chinese.</citation>
    <PMID>23980046</PMID>
  </reference>
  <reference>
    <citation>Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.</citation>
    <PMID>26537907</PMID>
  </reference>
  <reference>
    <citation>Atallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23.</citation>
    <PMID>24272607</PMID>
  </reference>
  <reference>
    <citation>Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151.</citation>
    <PMID>26466751</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mohammad Zuhdy</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <keyword>Minimally invasive surgery</keyword>
  <keyword>trans-anal total mesorectal excision</keyword>
  <keyword>Laparoscopic total mesoretal excision</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03242187
org study id: MansTaTME/17.04.84
nct id: NCT03242187
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to assess the surgical, oncological and functional outcome of either
      the laparoscopic or trans-anal TME in management of mid and low rectal cancer.
Colorectal cancer (CRC) is considered the third most common type of cancer all over the world
      and the fourth common cause of cancer-specific mortality.Surgical management for rectal
      cancer is challenging due to the narrow pelvis and extreme proximity to contiguous organs
      hence, recurrence rates are commonly reported.

      The advent of total mesorectal excision (TME) together with minimally invasive techniques
      such as laparoscopic colorectal surgery have not only improved surgical results but have also
      improved surgical technique, operative ability and surgical visibility. Lap TME has been
      shown to give similar results to the classical open approach with regard to peri-operative
      morbidity, surgical margins, quality of the surgical specimen, and number of resected lymph
      nodes, local recurrence and overall survival.

      However, laparoscopic resection of mid and low rectal cancer is technically difficult due to
      tapering of the mesorectum in the pelvis and the forward angle of the distal rectum rendering
      this part of the rectum less accessible from the abdominal cavity. This may lead to
      incomplete mesorectal excision and involved circumferential resection margins (CRMs), with
      consequent local recurrences.Previous pelvic radiation can make laparoscopic pelvic
      dissection more difficult, and tumors located on the anterior rectal wall have an increased
      risk of inadequate oncological clearance. The use of laparoscopic staplers in a narrow pelvis
      is difficult and the multiple firings of staples across the low rectum is of concern.

      Trans-anal Total Mesorectal Excision (TaTME) was recently developed to overcome technical
      difficulties associated with Lap TME and open TME. It may address some of the difficult
      aspects of laparoscopic or open TME, such as exposure, rectal dissection, and distal
      cross-stapling of the rectum and sphincter preservation. It does not only facilitate
      dissection of the difficult distal part of the TME dissection in the narrow pelvis but it
      also allows clear definition of safe, tumor-free, radial and longitudinal margins. Moreover,
      the specimen could be extracted through the anus excluding the need for minilaparotmy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Circumferential radial margin (CRM)
time frame: 2 years
description: Percentage of participants with involved circumferential margin(pathological assessment)
measure: Distal safety margin
time frame: 2 years
description: Distance of free distal margin in mm (pathological assessment)
measure: Number of lymph nodes retrieved
time frame: 2 years
description: Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)
measure: Morbidity rate
time frame: 2 years
description: Number of intra-operative and post-operative encountered complications
measure: Rate of conversion
time frame: 2 years
description: Percentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases
measure: Disease free survival
time frame: 30 months
description: Time till development of local or distant recurrence in months
measure: Functional outcome
time frame: 18 months
description: Assessment of functional outcome via questionnaires
arm group label: Trans-anal TME (TaTME)
arm group type: Experimental
description: Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
arm group label: Lap. TME
arm group type: Active Comparator
description: Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
intervention type: Procedure
intervention name: Trans-anal total mesorectal excision(TaTME)
description: Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
arm group label: Trans-anal TME (TaTME)
other name: Bottom to up approach
intervention type: Procedure
intervention name: Lap. TME
description: Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
arm group label: Lap. TME
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammad Z Metwally, Ass.Lecturer
phone: 00201068683363
email: mohammadzuhdy@gmail.com
last name: Sameh R Abdelazeez, Professor
email: samehroshdy20@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.
PMID: 24225001
citation: Vennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;(4):CD005200. doi: 10.1002/14651858.CD005200.pub3.
PMID: 24737031
citation: Qu C, Yuan RF, Huang J, Liu L, Jiang CH, Yang ZQ, Shao JH. [Meta-analysis of laparoscopic versus open total mesorectal excision for middle and low rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Aug;16(8):748-52. Chinese.
PMID: 23980046
citation: Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.
PMID: 26537907
citation: Atallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23.
PMID: 24272607
citation: Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151.
PMID: 26466751
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mohammad Zuhdy
investigator title: Assistant Lecturer
mesh term: Rectal Neoplasms
sharing ipd: No