xml: <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/NCT05961969</url>
    </required_header>
    <id_info>
      <org_study_id>202107066RINA</org_study_id>
      <nct_id>NCT05961969</nct_id>
    </id_info>
    <brief_title>Robotic Top-down Intersphincteric Resection</brief_title>
    <official_title>A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        The present study is to develop the novel robotic surgical technique and enhance the surgery&#xD;
        quality for the treatment of distal rectal cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a&#xD;
        complex two-step surgical procedure consisting of transabdominal mobilization of the&#xD;
        anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability&#xD;
        of robotic systems may facilitate the transabdominal approach, simplify the surgical&#xD;
        procedures, and achieve better anorectal function for patients with distal rectal cancer&#xD;
        requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the&#xD;
        single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited.&#xD;
        The risk factors for a failed transabdominal ISR were identified from the prospectively&#xD;
        maintained clinicopathologic data using univariate and multivariate analysis. The surgical&#xD;
        outcomes, the anorectal function, and the tumor recurrence were compared between patients&#xD;
        with a successful or failed robotic transabdominal ISR. The investigators believe that the&#xD;
        present project can facilitate the development of the novel robotic surgical technique and&#xD;
        enhance the surgery quality for the treatment of distal rectal cancer in our hospital and&#xD;
        even in Taiwan.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 21, 2022</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Completion of transabdominal ISR</measure>
      <time_frame>About one week</time_frame>
      <description>The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis;&#xD;
  the proximal and distal stapled tissue doughnuts recovered from EEA device were intact;&#xD;
  A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen;&#xD;
  To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Circumferential resection margin (CRM)</measure>
      <time_frame>About one week</time_frame>
      <description>The radicality of CRM will be evaluated by a pathologist for any tumor invasion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distal and proximal resection margin</measure>
      <time_frame>About one week</time_frame>
      <description>The radicality of distal and proximal margin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of operation time</measure>
      <time_frame>Through the completion of surgery, an average of 5 hours</time_frame>
      <description>The duration between skin incision and wound dressing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of postoperative ileus</measure>
      <time_frame>30 days</time_frame>
      <description>One of the most common postoperative complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization</measure>
      <time_frame>After patients' discharge from hospital, an average of 7 days</time_frame>
      <description>The total days of stay in hospital during postoperative period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Degree of postoperative pain</measure>
      <time_frame>After patients' discharge from hospital, an average of 7 days</time_frame>
      <description>The visual analogue scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative complications</measure>
      <time_frame>Within 5 hours</time_frame>
      <description>Any adverse effect will be recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The wound infection</measure>
      <time_frame>30 days</time_frame>
      <description>the presence of thin discharge or local abscess in the operative wound, followed by the confirmation with Gram stains or bacterial cultures.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute anastomotic leakage</measure>
      <time_frame>30 days</time_frame>
      <description>The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chronic anastomotic leakage</measure>
      <time_frame>6 months</time_frame>
      <description>a defect at the anastomotic site that results in a communication with the bowel lumen.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire to assess disability</measure>
      <time_frame>6 months</time_frame>
      <description>Standardized questionnaire was given to patients to assess disability that included the number of days until return to partial activity, full activity, and work on the basis of their subjective responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal incontinence</measure>
      <time_frame>6 months</time_frame>
      <description>Wexner score, also known as Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) is a fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection</arm_group_label>
      <description>Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Robotic surgery</intervention_name>
      <description>Patients with rectal cancer.&#xD;
  Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis</description>
      <arm_group_label>Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patients diagnosed as rectal cancer and met with the above inclusion and exclusion&#xD;
          criteria will be recruited.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal&#xD;
               sling (4 cm from anal verge), in which the required surgery meets the definition of&#xD;
               ISR;&#xD;
  &#xD;
            -  Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;&#xD;
  &#xD;
            -  Curative and elective surgery;&#xD;
  &#xD;
            -  American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;&#xD;
  &#xD;
            -  Age between 20 and 75 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent&#xD;
               pelvic organs;&#xD;
  &#xD;
            -  Evidence of distant metastasis;&#xD;
  &#xD;
            -  Primary tumor mass≧8 cm in diameter;&#xD;
  &#xD;
            -  Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;&#xD;
  &#xD;
            -  Previous major surgery of low upper abdomen;&#xD;
  &#xD;
            -  The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic&#xD;
               lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence&#xD;
               Score≧ 10)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jin-Tung LIANG, PhD</last_name>
      <role>Study Director</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jin-Tung LIANG, PhD</last_name>
      <phone>+886-9-72-651432</phone>
      <email>jintung@ntu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jin-Tung LIANG</name>
        <address>
          <city>Taipei</city>
          <zip>886</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jin-Tung LIANG, PhD</last_name>
        <phone>+886-9-72-651432</phone>
        <email>jintung@ntu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2022</verification_date>
    <study_first_submitted>July 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intersphincteric resection (ISR)</keyword>
    <keyword>Transabdominal ISR</keyword>
    <keyword>Top-down ISR</keyword>
    <keyword>Transanal ISR</keyword>
    <keyword>Rectal cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961969
  org study id: 202107066RINA
  nct id: NCT05961969
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study is to develop the novel robotic surgical technique and enhance the surgery
        quality for the treatment of distal rectal cancer.
  The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a
        complex two-step surgical procedure consisting of transabdominal mobilization of the
        anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability
        of robotic systems may facilitate the transabdominal approach, simplify the surgical
        procedures, and achieve better anorectal function for patients with distal rectal cancer
        requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the
        single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited.
        The risk factors for a failed transabdominal ISR were identified from the prospectively
        maintained clinicopathologic data using univariate and multivariate analysis. The surgical
        outcomes, the anorectal function, and the tumor recurrence were compared between patients
        with a successful or failed robotic transabdominal ISR. The investigators believe that the
        present project can facilitate the development of the novel robotic surgical technique and
        enhance the surgery quality for the treatment of distal rectal cancer in our hospital and
        even in Taiwan.
  observational model: Cohort
  time perspective: Prospective
  measure: Completion of transabdominal ISR
  time frame: About one week
  description: The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis;
  the proximal and distal stapled tissue doughnuts recovered from EEA device were intact;
  A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen;
  To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove.
  measure: Circumferential resection margin (CRM)
  time frame: About one week
  description: The radicality of CRM will be evaluated by a pathologist for any tumor invasion
  measure: Distal and proximal resection margin
  time frame: About one week
  description: The radicality of distal and proximal margin
  measure: Length of operation time
  time frame: Through the completion of surgery, an average of 5 hours
  description: The duration between skin incision and wound dressing
  measure: Length of postoperative ileus
  time frame: 30 days
  description: One of the most common postoperative complication
  measure: Hospitalization
  time frame: After patients' discharge from hospital, an average of 7 days
  description: The total days of stay in hospital during postoperative period
  measure: Degree of postoperative pain
  time frame: After patients' discharge from hospital, an average of 7 days
  description: The visual analogue scale
  measure: Intraoperative complications
  time frame: Within 5 hours
  description: Any adverse effect will be recorded.
  measure: The wound infection
  time frame: 30 days
  description: the presence of thin discharge or local abscess in the operative wound, followed by the confirmation with Gram stains or bacterial cultures.
  measure: Acute anastomotic leakage
  time frame: 30 days
  description: The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization.
  measure: Chronic anastomotic leakage
  time frame: 6 months
  description: a defect at the anastomotic site that results in a communication with the bowel lumen.
  measure: Questionnaire to assess disability
  time frame: 6 months
  description: Standardized questionnaire was given to patients to assess disability that included the number of days until return to partial activity, full activity, and work on the basis of their subjective responses.
  measure: Fecal incontinence
  time frame: 6 months
  description: Wexner score, also known as Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) is a fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence.
  arm group label: Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection
  description: Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis
  intervention type: Procedure
  intervention name: Robotic surgery
  description: Patients with rectal cancer.
  Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis
  arm group label: Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jin-Tung LIANG, PhD
  role: Study Director
  affiliation: National Taiwan University Hospital
  last name: Jin-Tung LIANG, PhD
  phone: +886-9-72-651432
  email: jintung@ntu.edu.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms