<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/NCT03013153</url>
  </required_header>
  <id_info>
    <org_study_id>LAND</org_study_id>
    <nct_id>NCT03013153</nct_id>
  </id_info>
  <brief_title>Low or High Ligation of the IMA With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery</brief_title>
  <official_title>Low or High Ligation of the Inferior Mesenteric Artery With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial (LAND)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sixth Affiliated Hospital, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still&#xD;
      argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing&#xD;
      the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis,&#xD;
      and total mesorectum excision. However, debate on the level of IMA ligation and debonding of&#xD;
      splenic flexure never ends. This study is going to give a clear and definite answer to how&#xD;
      and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D&#xD;
      reconstruction of IMA and identification of IMA perfusion types.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the report of World Health Organization 2015, the morbility and mortality of&#xD;
      colorectal cancer (CRC) are rising all over the world. Although the technique gets great&#xD;
      approval in CRC surgical treatment in the recent years, such as TME protocol, neoadjuvant and&#xD;
      laparoscopy technique, the complication of anastomosis leakage and nerve damage are still to&#xD;
      be solved.&#xD;
&#xD;
      Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still&#xD;
      argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing&#xD;
      the inferior mesenteric artery, protection of autonomic nerve, low rectal anastomosis, and&#xD;
      total mesorectum excision. However, debate on where is the best level of IMA ligation and&#xD;
      whether splenic flexure be debonded never ends. This study is going to give a clear and&#xD;
      definite answer to how and why surgeons should deal with the IMA in laparoscopy rectal&#xD;
      surgery.&#xD;
&#xD;
      The ligation level of IMA affects on hypogastric and pelvic nerve, leads to disorder of&#xD;
      sexual and urination functions. What's more, it also have affection on the apical lymph node&#xD;
      (No.253) harvesting and the blood supplement of proximal colon. Former studies have proved&#xD;
      that the blood supplement and tension of anastomosis leads to leakage after surgery.&#xD;
      Meanwhile, the ligation level of IMA is the key point on it.&#xD;
&#xD;
      The former study comes from the sixth affiliated hospital found that the mistake of ligation&#xD;
      level of IMA happened because of the poor touching and explosion with laparoscopy. The&#xD;
      distance from the root of IMA to left colic artery (DRL) vary between 19mm and 64mm. When&#xD;
      surgeon made mistake during ligation, it led to the insufficient resection of apical lymph&#xD;
      node. Further more, affect the long-term survival. Besides, there are 4 different types of&#xD;
      IMA according to the relationship between the left colic artery, sigmoid artery and superior&#xD;
      rectal artery. These branches will confuse surgeon on how to deal with them. 3D&#xD;
      reconstruction of abdominal pelvic CT is able to show the length of DRL, IMA types and apical&#xD;
      lymph nodes clearly. With these technique, the investigators can preserve the left colic&#xD;
      artery and resect apical lymph nodes precisely.&#xD;
&#xD;
      In the past studies, high or low ligation takes advantage on both side. But none of them&#xD;
      comes from retrospective clinical trail. Some author believe that high ligation do better in&#xD;
      resection of apical lymph nodes, release the tension of anastomosis, providing precise tumor&#xD;
      staging. On the other side, some authors consider that high ligation may cut down blood&#xD;
      supplement, rise the incident of anastomosis leakage (AL). so they prefer low ligation to the&#xD;
      high. Some studies show that there are no long term survival difference between high and low&#xD;
      ligation on IMA in laparoscopy rectal resection. So whether high ligation is necessary, still&#xD;
      to be proved.&#xD;
&#xD;
      For local advanced rectal cancer, neoadjuvant chemotherapy can lesson tumor size, reduce&#xD;
      recurrence, preserve annual better and rise long-term survival. National Comprehensive Cancer&#xD;
      Network command chemotherapy before surgery (Total Mesorectal Excision TME) as the standard&#xD;
      for rectal cancer since 2005. Another randomized controlled trial (RCT) named Neoadjuvant&#xD;
      FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) NCT01211210 has&#xD;
      proved the recent positive result. In those cases, the positive metastasis apical lymph node&#xD;
      appeared in less than 5% (5/116) cases. On the other side, the incident of AL was up to 7%&#xD;
      (8/116) . This phenomenon discover that maybe low ligation with apical lymph nodes dissection&#xD;
      can get the same treatment effect and decrease AL from happening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5-years overall survival rate</measure>
    <time_frame>5 years</time_frame>
    <description>5-years overall survival rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-years disease free survival rate</measure>
    <time_frame>5 years</time_frame>
    <description>5-years disease free survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year overall survival rate</measure>
    <time_frame>1 year</time_frame>
    <description>1-year overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year disease free survival rate</measure>
    <time_frame>1 year</time_frame>
    <description>1-year disease free survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anastomosis leakage rate</measure>
    <time_frame>6 months</time_frame>
    <description>anastomosis leakage rate after surgery, acute or chronic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apical Lymph Nodes (LN) Positive Rate</measure>
    <time_frame>1 week</time_frame>
    <description>Apical Lymph Nodes Positive Rate, No.253 LN</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation Time</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss during operation</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication incident rate of surgery</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>conversion rate to laparotomy</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of IMA perfusion type before surgery</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of lymph node metastasis by CT</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate in 30 days after surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery time after surgery</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White cell level</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reaction protein level</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin level</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anastomosis bleeding rate after surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anastomosis stenosis rate after surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal dysfunction after stoma closure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anus function after surgery</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life quality scoring</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder residual urine volume</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function scoring</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">748</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Low ligation with apical lymph node dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High ligation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low ligation with apical lymph node dissection</intervention_name>
    <description>Low ligation with apical lymph node dissection (LAND). Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta.</description>
    <arm_group_label>Low ligation with apical lymph node dissection</arm_group_label>
    <other_name>LAND</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High ligation</intervention_name>
    <description>High ligation (HL) Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.</description>
    <arm_group_label>High ligation</arm_group_label>
    <other_name>HL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathology shows rectal or sigmoid adenocarcinoma&#xD;
&#xD;
          -  The bottom edge of tumor to anuas is less than 15cm&#xD;
&#xD;
          -  The clinical staging of tumor by American Joint Committee on Cancer (AJCC) within T2-4&#xD;
             or N1-2&#xD;
&#xD;
          -  Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery&#xD;
&#xD;
          -  Racial resection in available after neoadjuvant chemotherapy&#xD;
&#xD;
          -  No metastasis evidence was found&#xD;
&#xD;
          -  Annual preservation surgery is available&#xD;
&#xD;
          -  Tolerate to general anesthesia&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) status score between 0 and 1&#xD;
&#xD;
          -  Patients and general anesthesia can understand the clinical trail well and are willing&#xD;
             to take part in&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffer with other carcinoma synchronous or metachronous in 5 years&#xD;
&#xD;
          -  Multiple primary colon carcinoma&#xD;
&#xD;
          -  Radiation therapy was performed before surgery&#xD;
&#xD;
          -  History of colorectal surgery&#xD;
&#xD;
          -  Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation&#xD;
             and emergency surgery is needed&#xD;
&#xD;
          -  Multiple organs resection surgery is needed&#xD;
&#xD;
          -  Abdominal perineal resection is performed&#xD;
&#xD;
          -  American Society of Anesthesiologists score stage IV to V&#xD;
&#xD;
          -  Pregnant, suckling period or reject to contraception&#xD;
&#xD;
          -  Severe cardiovascular disease, uncontrollable infection or other severe complication&#xD;
&#xD;
          -  Severe mental illness&#xD;
&#xD;
          -  Unable to go through the treatment because of family, society or regional condition&#xD;
&#xD;
          -  Refuse to take part in the trail&#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>Meijin Huang, MD</last_name>
    <role>Study Director</role>
    <affiliation>The sixth affiliated hospital, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiaming Zhou, MD</last_name>
    <phone>+8613560031075</phone>
    <email>cysums03@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meijin Huang, MD</last_name>
    <phone>+8613924073322</phone>
    <email>13924073322@139.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The sixth affiliated hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meijin Huang, MD</last_name>
      <phone>+8613924073322</phone>
      <email>13924073322@139.com</email>
    </contact>
    <contact_backup>
      <last_name>Jiaming Zhou, MD</last_name>
      <phone>+8613560031075</phone>
      <email>cysums03@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jiaping Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meijin Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jiaming Zhou, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rectal Cancer</keyword>
  <keyword>Inferior Mesenteric Artery</keyword>
  <keyword>Ligation</keyword>
  <keyword>Apical Lymph Nodes</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>IMA Types</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>Yes</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/NCT03013153
org study id: LAND
nct id: NCT03013153
lead sponsor: 
has dmc: Yes
Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still
      argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing
      the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis,
      and total mesorectum excision. However, debate on the level of IMA ligation and debonding of
      splenic flexure never ends. This study is going to give a clear and definite answer to how
      and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D
      reconstruction of IMA and identification of IMA perfusion types.
According to the report of World Health Organization 2015, the morbility and mortality of
      colorectal cancer (CRC) are rising all over the world. Although the technique gets great
      approval in CRC surgical treatment in the recent years, such as TME protocol, neoadjuvant and
      laparoscopy technique, the complication of anastomosis leakage and nerve damage are still to
      be solved.

      Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still
      argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing
      the inferior mesenteric artery, protection of autonomic nerve, low rectal anastomosis, and
      total mesorectum excision. However, debate on where is the best level of IMA ligation and
      whether splenic flexure be debonded never ends. This study is going to give a clear and
      definite answer to how and why surgeons should deal with the IMA in laparoscopy rectal
      surgery.

      The ligation level of IMA affects on hypogastric and pelvic nerve, leads to disorder of
      sexual and urination functions. What's more, it also have affection on the apical lymph node
      (No.253) harvesting and the blood supplement of proximal colon. Former studies have proved
      that the blood supplement and tension of anastomosis leads to leakage after surgery.
      Meanwhile, the ligation level of IMA is the key point on it.

      The former study comes from the sixth affiliated hospital found that the mistake of ligation
      level of IMA happened because of the poor touching and explosion with laparoscopy. The
      distance from the root of IMA to left colic artery (DRL) vary between 19mm and 64mm. When
      surgeon made mistake during ligation, it led to the insufficient resection of apical lymph
      node. Further more, affect the long-term survival. Besides, there are 4 different types of
      IMA according to the relationship between the left colic artery, sigmoid artery and superior
      rectal artery. These branches will confuse surgeon on how to deal with them. 3D
      reconstruction of abdominal pelvic CT is able to show the length of DRL, IMA types and apical
      lymph nodes clearly. With these technique, the investigators can preserve the left colic
      artery and resect apical lymph nodes precisely.

      In the past studies, high or low ligation takes advantage on both side. But none of them
      comes from retrospective clinical trail. Some author believe that high ligation do better in
      resection of apical lymph nodes, release the tension of anastomosis, providing precise tumor
      staging. On the other side, some authors consider that high ligation may cut down blood
      supplement, rise the incident of anastomosis leakage (AL). so they prefer low ligation to the
      high. Some studies show that there are no long term survival difference between high and low
      ligation on IMA in laparoscopy rectal resection. So whether high ligation is necessary, still
      to be proved.

      For local advanced rectal cancer, neoadjuvant chemotherapy can lesson tumor size, reduce
      recurrence, preserve annual better and rise long-term survival. National Comprehensive Cancer
      Network command chemotherapy before surgery (Total Mesorectal Excision TME) as the standard
      for rectal cancer since 2005. Another randomized controlled trial (RCT) named Neoadjuvant
      FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) NCT01211210 has
      proved the recent positive result. In those cases, the positive metastasis apical lymph node
      appeared in less than 5% (5/116) cases. On the other side, the incident of AL was up to 7%
      (8/116) . This phenomenon discover that maybe low ligation with apical lymph nodes dissection
      can get the same treatment effect and decrease AL from happening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 5-years overall survival rate
time frame: 5 years
description: 5-years overall survival rate
measure: 5-years disease free survival rate
time frame: 5 years
description: 5-years disease free survival rate
measure: 1-year overall survival rate
time frame: 1 year
description: 1-year overall survival rate
measure: 1-year disease free survival rate
time frame: 1 year
description: 1-year disease free survival rate
measure: Anastomosis leakage rate
time frame: 6 months
description: anastomosis leakage rate after surgery, acute or chronic
measure: Apical Lymph Nodes (LN) Positive Rate
time frame: 1 week
description: Apical Lymph Nodes Positive Rate, No.253 LN
measure: Operation Time
time frame: 1 day
measure: Blood loss during operation
time frame: 1 day
measure: Complication incident rate of surgery
time frame: 1 day
measure: conversion rate to laparotomy
time frame: 1 day
measure: Identification of IMA perfusion type before surgery
time frame: 1 day
measure: Identification of lymph node metastasis by CT
time frame: 7 days
measure: Mortality rate in 30 days after surgery
time frame: 30 days
measure: Recovery time after surgery
time frame: 60 days
measure: White cell level
time frame: 7 days
measure: C-reaction protein level
time frame: 7 days
measure: Albumin level
time frame: 7 days
measure: Anastomosis bleeding rate after surgery
time frame: 30 days
measure: Anastomosis stenosis rate after surgery
time frame: 30 days
measure: Intestinal dysfunction after stoma closure
time frame: 1 year
measure: Anus function after surgery
time frame: 1 year
measure: Life quality scoring
time frame: 1 year
measure: Bladder residual urine volume
time frame: 1 year
measure: Sexual function scoring
time frame: 1 year
arm group label: Low ligation with apical lymph node dissection
arm group type: Experimental
description: Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
arm group label: High ligation
arm group type: Active Comparator
description: Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
intervention type: Procedure
intervention name: Low ligation with apical lymph node dissection
description: Low ligation with apical lymph node dissection (LAND). Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta.
arm group label: Low ligation with apical lymph node dissection
other name: LAND
intervention type: Procedure
intervention name: High ligation
description: High ligation (HL) Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
arm group label: High ligation
other name: HL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Meijin Huang, MD
role: Study Director
affiliation: The sixth affiliated hospital, Sun Yat-sen University
last name: Jiaming Zhou, MD
phone: +8613560031075
email: cysums03@163.com
last name: Meijin Huang, MD
phone: +8613924073322
email: 13924073322@139.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
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responsible party type: Sponsor
mesh term: Rectal Neoplasms
sharing ipd: Yes