<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/NCT04481659</url>
  </required_header>
  <id_info>
    <org_study_id>ZhongnanH1</org_study_id>
    <nct_id>NCT04481659</nct_id>
  </id_info>
  <brief_title>Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer</brief_title>
  <official_title>Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer: A Non-randomized, Prospective, Single-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongnan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongnan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined&#xD;
      abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is&#xD;
      time consuming and difficult to accomplish. A complete laparoscopic abdominal approach&#xD;
      partial intersphincteric resection has been proved to be a safe and feasible alternative for&#xD;
      low rectal cancer treatment, with the advantages of technical convenience and avoiding a&#xD;
      permanent ostomy. But there are few reports concerning differences in clinical outcomes&#xD;
      between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR&#xD;
      surgery. Therefore, it is necessary to compare the functional outcomes (including anal and&#xD;
      sexual function, and postoperative quality of life [QOL]) and oncologic outcomes of patients&#xD;
      who underwent completely abdominal approach laparoscopic partial ISR surgery after&#xD;
      neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the&#xD;
      operation difficulty between the above two groups is also worthy of intensive study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal&#xD;
      approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly&#xD;
      treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The&#xD;
      postoperatively functional outcomes and oncologic outcomes between the two groups are&#xD;
      compared, including anal and sexual function, QOL and local recurrence rate. The operation&#xD;
      difficulty between the above two groups is also investigated, including operation time, the&#xD;
      intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the&#xD;
      intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis&#xD;
      coccygeus, puborectalis, and external sphincter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 19, 2020</start_date>
  <completion_date type="Anticipated">July 19, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 19, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The damage degree of anal function</measure>
    <time_frame>5 years</time_frame>
    <description>The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time for mobilizing the intersphincteric space</measure>
    <time_frame>5 years</time_frame>
    <description>Time for mobilizing the intersphincteric space</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The intactness of levator anus muscle fascia</measure>
    <time_frame>5 years</time_frame>
    <description>The intactness of levator anus muscle fascia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin</measure>
    <time_frame>5 years</time_frame>
    <description>The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative and postoperative complications</measure>
    <time_frame>5 years</time_frame>
    <description>Intraoperative and postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence</measure>
    <time_frame>5 years</time_frame>
    <description>Local recurrence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>A group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team [MDT] group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lap partial ISR</intervention_name>
    <description>A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection</description>
    <arm_group_label>A group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>NCRT+Lap partial ISR</intervention_name>
    <description>Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection</description>
    <arm_group_label>B group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy-proven moderate or well differentiated adenocarcinoma&#xD;
&#xD;
          -  Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)&#xD;
&#xD;
          -  Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant&#xD;
             chemoradiotherapy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Without signing informed consent, poor compliance&#xD;
&#xD;
          -  Unfit for laparoscopy&#xD;
&#xD;
          -  Other serious diseases not suitable for participating in this clinical trial&#xD;
&#xD;
          -  A degree of preoperative fecal incontinence&#xD;
&#xD;
          -  After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual&#xD;
             function and others involved in this trail are seriously affected&#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_contact>
    <last_name>Qun Qian, M.D.</last_name>
    <phone>(+86)13517110773</phone>
    <email>wb002554@whu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongnan Hospital, Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430071</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qun Qian, M.D.</last_name>
      <phone>(+86)13517110773</phone>
      <email>wb002554@whu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT04481659
org study id: ZhongnanH1
nct id: NCT04481659
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined
      abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is
      time consuming and difficult to accomplish. A complete laparoscopic abdominal approach
      partial intersphincteric resection has been proved to be a safe and feasible alternative for
      low rectal cancer treatment, with the advantages of technical convenience and avoiding a
      permanent ostomy. But there are few reports concerning differences in clinical outcomes
      between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR
      surgery. Therefore, it is necessary to compare the functional outcomes (including anal and
      sexual function, and postoperative quality of life [QOL]) and oncologic outcomes of patients
      who underwent completely abdominal approach laparoscopic partial ISR surgery after
      neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the
      operation difficulty between the above two groups is also worthy of intensive study.
Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal
      approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly
      treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The
      postoperatively functional outcomes and oncologic outcomes between the two groups are
      compared, including anal and sexual function, QOL and local recurrence rate. The operation
      difficulty between the above two groups is also investigated, including operation time, the
      intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the
      intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis
      coccygeus, puborectalis, and external sphincter.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The damage degree of anal function
time frame: 5 years
description: The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.
measure: Time for mobilizing the intersphincteric space
time frame: 5 years
description: Time for mobilizing the intersphincteric space
measure: The intactness of levator anus muscle fascia
time frame: 5 years
description: The intactness of levator anus muscle fascia
measure: he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
time frame: 5 years
description: The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
measure: Intraoperative and postoperative complications
time frame: 5 years
description: Intraoperative and postoperative complications
measure: Local recurrence
time frame: 5 years
description: Local recurrence
arm group label: A group
arm group type: Experimental
description: Patients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team [MDT] group)
arm group label: B group
arm group type: Experimental
description: Patients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy.
intervention type: Procedure
intervention name: Lap partial ISR
description: A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection
arm group label: A group
intervention type: Combination Product
intervention name: NCRT+Lap partial ISR
description: Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection
arm group label: B group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qun Qian, M.D.
phone: (+86)13517110773
email: wb002554@whu.edu.cn
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Rectal Neoplasms
sharing ipd: Undecided