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/NCT05970133</url>
    </required_header>
    <id_info>
      <org_study_id>202301224RINB</org_study_id>
      <nct_id>NCT05970133</nct_id>
    </id_info>
    <brief_title>Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer</brief_title>
    <official_title>Functional Recovery and Oncologic Efficacy of Robotic Versus Laparoscopy NOSE for Patients With Stage I III Left Sided Colon Cancer: A Randomized Controlled Trial</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this project, the investigator aims to provide the level 1 evidence for the comparison of&#xD;
        robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the&#xD;
        investigator hypothesize that, with the increased maneuverability of the current robotic&#xD;
        system, robotic surgery will be a good option for patients with stage I-III colorectal cancer&#xD;
        requiring a NOSE procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Over the past three decades, laparoscopic surgery has evolved incessantly, especially in the&#xD;
        field of colorectal surgery. It has been widely accepted by surgeons and patients in light of&#xD;
        the better peri-operative outcomes and analogical long-term effectiveness, compared with open&#xD;
        surgery for colorectal cancers. However, current conventional laparoscopic colorectal surgery&#xD;
        requires an additional abdominal incision for specimen retrieval and sometimes for intestinal&#xD;
        reconstruction, which increases the risk of various postoperative complications, including&#xD;
        pain, surgical site infection, incisional hernia, and injury to the epigastric artery and&#xD;
        abdominal cutaneous nerves, and, consequently, can delay postoperative chemotherapy.&#xD;
  &#xD;
        To mitigate these unfavorable outcomes, natural orifice specimen extraction (NOSE) via the&#xD;
        anus, stomach, or vagina, was introduced. One randomized trial reported better short-term&#xD;
        surgical outcomes, including reduced pain and lower analgesia requirements for laparoscopic&#xD;
        NOSE colectomy, compared with conventional laparoscopic colectomy. Transanal specimen&#xD;
        extraction has been utilized after laparoscopic colon or rectal cancer surgery and has been&#xD;
        found to be feasible, safe, and oncologically sound in selected cases. Several multiport&#xD;
        laparoscopic platforms are currently available to complete all NOSE procedures and&#xD;
        reestablish intestinal continuity with a single stapled anastomosis, which has been shown to&#xD;
        improve short-term results compared with conventional laparoscopic colectomy. However,&#xD;
        concerns remain regarding the long-term oncologic safety (tumor cell spillage with local&#xD;
        recurrence and long-term survival) when NOSE is used for colorectal malignancy.&#xD;
  &#xD;
        A barrier to wider adoption of NOSE is technical difficulty. The mini-laparotomy, in some&#xD;
        cases, is used to perform a majority of the operation, as in hand-assisted laparoscopy.&#xD;
        Adoption of NOSE by surgeons who typically perform colectomies in this fashion would be faced&#xD;
        with a steeper learning curve than surgeons who use the mini-laparotomy solely as a specimen&#xD;
        extraction site. On that note, intracorporeal anastomosis is a prerequisite skill for those&#xD;
        adopting NOSE. Removal of more proximal specimens, as in a right colectomy, requires the&#xD;
        presence of a skilled endoscopist who can snare and pull the specimen endoluminally through&#xD;
        the length of the distal gastrointestinal tract. Specimen extraction via the vagina requires&#xD;
        a posterior colpotomy, an operative maneuver that is not typically performed by general or&#xD;
        colorectal surgeons. Furthermore, these technical challenges are amplified by a lack of&#xD;
        standardization of the technique.&#xD;
  &#xD;
        The demands for these technical skills are more important in removing right-sided colon&#xD;
        pathology, as compared to left-sided pathology. There are inherent anatomic factors that make&#xD;
        NOSE for right-sided colon pathology more difficult. Right colectomy specimens extracted&#xD;
        through the lower gastrointestinal tract via distal colotomy must travel the length of the&#xD;
        remaining transverse, descending, and sigmoid colon, through the rectum and out of the anus&#xD;
        using an endoscope. While this was demonstrated to be feasible in 2010 by Eshuis et al, it is&#xD;
        inherently difficult due to the anatomically narrow and torturous sigmoid colon. In that&#xD;
        series, extraction via colotomy failed in 2 of 10 patients due to the bulk of the specimen.&#xD;
        This technique is still performed in some centers, though limitations related to the size of&#xD;
        the specimen are stricter than for left-sided colon lesions. This approach has little&#xD;
        practicality due to its significant technical challenges, hence its limited use.&#xD;
  &#xD;
        Bacterial contamination is always a concern during the NOSE procedure. Most researchers&#xD;
        strongly suggest that mechanical bowel preparation, intraoperative transanal lavage with&#xD;
        povidone iodine solution, transluminal wound protector, and prophylactic antibiotics are&#xD;
        applied to reduce the bacterial load. Recently, a study showed that the risk of bacterial&#xD;
        contamination with NOSE was not significantly higher than that in conventional laparoscopic&#xD;
        surgery. In some studies, patients who had NOSE did not experience significant postoperative&#xD;
        morbidity or laboratory data changes, such as leukocytosis, CRP level elevation, rectal&#xD;
        wound-related complications or leakage, than the conventional group.&#xD;
  &#xD;
        Tumor size is considered before applying the NOSE procedure. Many authors limit indications&#xD;
        to tumors smaller than 3 - 6.5 cm. Some authors have stated that obese patients are not&#xD;
        suitable for transrectal specimen extraction and set the BMI cutoff at &gt; 28-35 kg/m2. Most&#xD;
        researchers considered patients with a bulky mesocolon, a narrow pelvis, and previous pelvic&#xD;
        surgery with severe adhesions were not eligible for NOSE.&#xD;
  &#xD;
        It is generally accepted that laparoscopic NOSE can achieve oncological and surgical safety&#xD;
        comparable to that of conventional laparoscopic surgery for patients with sigmoid and rectal&#xD;
        cancer. Remarkably, Laparoscopic NOSE patients were associated with a shorter hospital stay,&#xD;
        shorter time to first flatus or defecation, less postoperative pain, and fewer surgical site&#xD;
        infections and total perioperative complications. In general, the operative time in&#xD;
        laparoscopic NOSE was longer than that in conventional laparoscopic surgery. The long-term&#xD;
        oncological efficacy of laparoscopic NOSE seems to be equivalent to that of conventional&#xD;
        laparoscopic surgery. Furthermore, specimen retrieval through alternative routes to avoid an&#xD;
        abdominal incision is beneficial for the prevention of incisional hernia.&#xD;
  &#xD;
        Currently, robotic surgical approaches are becoming more popular for treating colorectal&#xD;
        cancer. Robotic techniques can overcome some technical limitations of laparoscopic surgery,&#xD;
        including an unstable camera view and straight laparoscopic instruments. Robotic surgery is&#xD;
        advantageous because it provides surgeon-control of the camera, high-definition&#xD;
        three-dimensional vision, excellent ergonomics, decreased physiological tremor, more freedom&#xD;
        of angles of instruments, and the ability to simultaneously control the camera and two&#xD;
        additional instruments that facilitate traction and countertraction, all of which enable to&#xD;
        facilitate the procedures, even in difficult settings.&#xD;
  &#xD;
        The unique advantages of the surgical robot make colorectal surgery operations more precise&#xD;
        and intelligent, providing more options for minimizing operative stress during colorectal&#xD;
        surgery. The proximity between the sigmoid colon and rectum to the anal location provides a&#xD;
        favorable predisposition for transanal specimen retrieval without significantly increasing&#xD;
        the difficulty of the surgical operation. However, to date, only very few studies compared&#xD;
        robotic NOSE versus laparoscopic NOSE for the surgery of colorectal cancer. Actually, our&#xD;
        preliminary data has shown the safety and feasibility of robotic NOSE, as compared with&#xD;
        laparoscopic NOSE for the surgery of colorectal cancer.&#xD;
  &#xD;
        Even to date, laparoscopic NOSE procedure for colorectal cancer is still not popular due to&#xD;
        the technique difficulty associated with an intra-corporeal anastomosis for NOSE and the&#xD;
        oncologic concern of tumor spillage at the staple line during tumor retrieval process. In&#xD;
        this respect, the introduction of robotic system can overcome the technical difficulties.&#xD;
  &#xD;
        In this project, the investigator aims to provide the level 1 evidence for the comparison of&#xD;
        robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the&#xD;
        investigator hypothesize that, with the increased maneuverability of the current robotic&#xD;
        system, robotic surgery will be a good option for patients with stage I-III colorectal cancer&#xD;
        requiring a NOSE procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 7, 2023</start_date>
    <completion_date type="Anticipated">October 6, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 6, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The surgical efficiency of both NOSE procedures</measure>
      <time_frame>Intraoperative hours with an average of 5 hours</time_frame>
      <description>The operation time defined as the incision of wound and application of the surgical dressing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall disease-free survival</measure>
      <time_frame>5 years</time_frame>
      <description>The duration between surgery and death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall recurrence-free survival</measure>
      <time_frame>5 years</time_frame>
      <description>The duration between surgery and recurrence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incontinence</measure>
      <time_frame>6 months</time_frame>
      <description>Evaluated by questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to return work</measure>
      <time_frame>1 year</time_frame>
      <description>Disability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total fee and equipment fee</measure>
      <time_frame>3 months</time_frame>
      <description>Total Cost</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood loss</measure>
      <time_frame>Intraoperative hours with an average of 5 years</time_frame>
      <description>measured by the amount Mof blood in suction bottle and the number of blood soaked gauzes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conversion rate</measure>
      <time_frame>Intraoperative hours with an average of 5 years</time_frame>
      <description>Conversion from robotic surgery to laparoscopic surgery or open surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>30 days</time_frame>
      <description>Any complication during or after surgery grading by Calvien -Dindo classification</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wound size</measure>
      <time_frame>Intraoperative hours with an average of 5 years</time_frame>
      <description>Total length of the wounds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum C reactive protein (CRP)</measure>
      <time_frame>Throughout the admission with an average of 7 days</time_frame>
      <description>CRP could be an indicator of the severity of surgical stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythrocyte sedimentation rate (ESR)</measure>
      <time_frame>Throughout the admission with an average of 7 days</time_frame>
      <description>ESR could be an indicator of the severity of surgical stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lymphocyte counts</measure>
      <time_frame>Throughout the admission with an average of 7 days</time_frame>
      <description>Blood lymphocyte counts could be an indicator of the severity of surgical stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CD4+ to CD8+ ratio</measure>
      <time_frame>ESR could be an indicator of the severity of surgical stress.</time_frame>
      <description>CD4 to CD8 ratio could be an indicator of the severity of surgical stress.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>Laparoscopic surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients in this group will undergo laparoscopic surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Robotic surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients in this group will undergo robotic surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Colectomy with NOSE procedure</intervention_name>
      <description>The specimen will be extract from the anus.</description>
      <arm_group_label>Laparoscopic surgery</arm_group_label>
      <arm_group_label>Robotic surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Primary colon cancers located at the left sided colonic anatomic location, including&#xD;
               distal transverse colon, colonic splenic flexure, descending colon, sigm oid&#xD;
               descending colonic junction, sigmoid colon and upper rectum that required the&#xD;
               mobilization of colonic splenic flexure to facilitate a curative resection and trans&#xD;
               anal specimen extraction ;&#xD;
  &#xD;
            2. TNM Stage I III adenocarcinomas;&#xD;
  &#xD;
            3. Curative and elective surgery;&#xD;
  &#xD;
            4. American Society of Anesthesiology (ASA) class I to III patients;&#xD;
  &#xD;
            5. Age &gt;18 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Cecal, ascending, the proximal and middle transverse colon cancers; and the middle or&#xD;
               lower rectal cancers;&#xD;
  &#xD;
            2. Emergency or palliative surgery;&#xD;
  &#xD;
            3. Evidence of disseminated disease or adjacent organ invasion;&#xD;
  &#xD;
            4. Primary tumor mass &gt;8 cm in diameter;&#xD;
  &#xD;
            5. Morbidly obese patients, that is, body mass index (BMI) ≥40 kg/m 2 ;&#xD;
  &#xD;
            6. Previous major surgery of upper abdomen or pelvis&#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_official>
      <last_name>Jin-Tung LIANG, MD</last_name>
      <role>Study Chair</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jin-Tung LIANG, MD</last_name>
      <phone>886-9-72651432</phone>
      <email>jintung@ntu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jin-Tung LIANG, MD</last_name>
        <phone>886-9-72651432</phone>
        <email>jintung@ntu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Colorectal cancer</keyword>
    <keyword>Natural orifice specimen extraction</keyword>
    <keyword>Laparoscopic surgery</keyword>
    <keyword>Robotic surgery</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/NCT05970133
  org study id: 202301224RINB
  nct id: NCT05970133
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this project, the investigator aims to provide the level 1 evidence for the comparison of
        robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the
        investigator hypothesize that, with the increased maneuverability of the current robotic
        system, robotic surgery will be a good option for patients with stage I-III colorectal cancer
        requiring a NOSE procedure.
  Over the past three decades, laparoscopic surgery has evolved incessantly, especially in the
        field of colorectal surgery. It has been widely accepted by surgeons and patients in light of
        the better peri-operative outcomes and analogical long-term effectiveness, compared with open
        surgery for colorectal cancers. However, current conventional laparoscopic colorectal surgery
        requires an additional abdominal incision for specimen retrieval and sometimes for intestinal
        reconstruction, which increases the risk of various postoperative complications, including
        pain, surgical site infection, incisional hernia, and injury to the epigastric artery and
        abdominal cutaneous nerves, and, consequently, can delay postoperative chemotherapy.
  
        To mitigate these unfavorable outcomes, natural orifice specimen extraction (NOSE) via the
        anus, stomach, or vagina, was introduced. One randomized trial reported better short-term
        surgical outcomes, including reduced pain and lower analgesia requirements for laparoscopic
        NOSE colectomy, compared with conventional laparoscopic colectomy. Transanal specimen
        extraction has been utilized after laparoscopic colon or rectal cancer surgery and has been
        found to be feasible, safe, and oncologically sound in selected cases. Several multiport
        laparoscopic platforms are currently available to complete all NOSE procedures and
        reestablish intestinal continuity with a single stapled anastomosis, which has been shown to
        improve short-term results compared with conventional laparoscopic colectomy. However,
        concerns remain regarding the long-term oncologic safety (tumor cell spillage with local
        recurrence and long-term survival) when NOSE is used for colorectal malignancy.
  
        A barrier to wider adoption of NOSE is technical difficulty. The mini-laparotomy, in some
        cases, is used to perform a majority of the operation, as in hand-assisted laparoscopy.
        Adoption of NOSE by surgeons who typically perform colectomies in this fashion would be faced
        with a steeper learning curve than surgeons who use the mini-laparotomy solely as a specimen
        extraction site. On that note, intracorporeal anastomosis is a prerequisite skill for those
        adopting NOSE. Removal of more proximal specimens, as in a right colectomy, requires the
        presence of a skilled endoscopist who can snare and pull the specimen endoluminally through
        the length of the distal gastrointestinal tract. Specimen extraction via the vagina requires
        a posterior colpotomy, an operative maneuver that is not typically performed by general or
        colorectal surgeons. Furthermore, these technical challenges are amplified by a lack of
        standardization of the technique.
  
        The demands for these technical skills are more important in removing right-sided colon
        pathology, as compared to left-sided pathology. There are inherent anatomic factors that make
        NOSE for right-sided colon pathology more difficult. Right colectomy specimens extracted
        through the lower gastrointestinal tract via distal colotomy must travel the length of the
        remaining transverse, descending, and sigmoid colon, through the rectum and out of the anus
        using an endoscope. While this was demonstrated to be feasible in 2010 by Eshuis et al, it is
        inherently difficult due to the anatomically narrow and torturous sigmoid colon. In that
        series, extraction via colotomy failed in 2 of 10 patients due to the bulk of the specimen.
        This technique is still performed in some centers, though limitations related to the size of
        the specimen are stricter than for left-sided colon lesions. This approach has little
        practicality due to its significant technical challenges, hence its limited use.
  
        Bacterial contamination is always a concern during the NOSE procedure. Most researchers
        strongly suggest that mechanical bowel preparation, intraoperative transanal lavage with
        povidone iodine solution, transluminal wound protector, and prophylactic antibiotics are
        applied to reduce the bacterial load. Recently, a study showed that the risk of bacterial
        contamination with NOSE was not significantly higher than that in conventional laparoscopic
        surgery. In some studies, patients who had NOSE did not experience significant postoperative
        morbidity or laboratory data changes, such as leukocytosis, CRP level elevation, rectal
        wound-related complications or leakage, than the conventional group.
  
        Tumor size is considered before applying the NOSE procedure. Many authors limit indications
        to tumors smaller than 3 - 6.5 cm. Some authors have stated that obese patients are not
        suitable for transrectal specimen extraction and set the BMI cutoff at > 28-35 kg/m2. Most
        researchers considered patients with a bulky mesocolon, a narrow pelvis, and previous pelvic
        surgery with severe adhesions were not eligible for NOSE.
  
        It is generally accepted that laparoscopic NOSE can achieve oncological and surgical safety
        comparable to that of conventional laparoscopic surgery for patients with sigmoid and rectal
        cancer. Remarkably, Laparoscopic NOSE patients were associated with a shorter hospital stay,
        shorter time to first flatus or defecation, less postoperative pain, and fewer surgical site
        infections and total perioperative complications. In general, the operative time in
        laparoscopic NOSE was longer than that in conventional laparoscopic surgery. The long-term
        oncological efficacy of laparoscopic NOSE seems to be equivalent to that of conventional
        laparoscopic surgery. Furthermore, specimen retrieval through alternative routes to avoid an
        abdominal incision is beneficial for the prevention of incisional hernia.
  
        Currently, robotic surgical approaches are becoming more popular for treating colorectal
        cancer. Robotic techniques can overcome some technical limitations of laparoscopic surgery,
        including an unstable camera view and straight laparoscopic instruments. Robotic surgery is
        advantageous because it provides surgeon-control of the camera, high-definition
        three-dimensional vision, excellent ergonomics, decreased physiological tremor, more freedom
        of angles of instruments, and the ability to simultaneously control the camera and two
        additional instruments that facilitate traction and countertraction, all of which enable to
        facilitate the procedures, even in difficult settings.
  
        The unique advantages of the surgical robot make colorectal surgery operations more precise
        and intelligent, providing more options for minimizing operative stress during colorectal
        surgery. The proximity between the sigmoid colon and rectum to the anal location provides a
        favorable predisposition for transanal specimen retrieval without significantly increasing
        the difficulty of the surgical operation. However, to date, only very few studies compared
        robotic NOSE versus laparoscopic NOSE for the surgery of colorectal cancer. Actually, our
        preliminary data has shown the safety and feasibility of robotic NOSE, as compared with
        laparoscopic NOSE for the surgery of colorectal cancer.
  
        Even to date, laparoscopic NOSE procedure for colorectal cancer is still not popular due to
        the technique difficulty associated with an intra-corporeal anastomosis for NOSE and the
        oncologic concern of tumor spillage at the staple line during tumor retrieval process. In
        this respect, the introduction of robotic system can overcome the technical difficulties.
  
        In this project, the investigator aims to provide the level 1 evidence for the comparison of
        robotic versus laparoscopic NOSE for the surgery of stage I-III colorectal cancer. the
        investigator hypothesize that, with the increased maneuverability of the current robotic
        system, robotic surgery will be a good option for patients with stage I-III colorectal cancer
        requiring a NOSE procedure.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The surgical efficiency of both NOSE procedures
  time frame: Intraoperative hours with an average of 5 hours
  description: The operation time defined as the incision of wound and application of the surgical dressing
  measure: Overall disease-free survival
  time frame: 5 years
  description: The duration between surgery and death
  measure: Overall recurrence-free survival
  time frame: 5 years
  description: The duration between surgery and recurrence
  measure: Incontinence
  time frame: 6 months
  description: Evaluated by questionnaire
  measure: Time to return work
  time frame: 1 year
  description: Disability
  measure: Total fee and equipment fee
  time frame: 3 months
  description: Total Cost
  measure: Blood loss
  time frame: Intraoperative hours with an average of 5 years
  description: measured by the amount Mof blood in suction bottle and the number of blood soaked gauzes
  measure: Conversion rate
  time frame: Intraoperative hours with an average of 5 years
  description: Conversion from robotic surgery to laparoscopic surgery or open surgery
  measure: Complications
  time frame: 30 days
  description: Any complication during or after surgery grading by Calvien -Dindo classification
  measure: Wound size
  time frame: Intraoperative hours with an average of 5 years
  description: Total length of the wounds
  measure: Serum C reactive protein (CRP)
  time frame: Throughout the admission with an average of 7 days
  description: CRP could be an indicator of the severity of surgical stress.
  measure: Erythrocyte sedimentation rate (ESR)
  time frame: Throughout the admission with an average of 7 days
  description: ESR could be an indicator of the severity of surgical stress.
  measure: Blood lymphocyte counts
  time frame: Throughout the admission with an average of 7 days
  description: Blood lymphocyte counts could be an indicator of the severity of surgical stress.
  measure: CD4+ to CD8+ ratio
  time frame: ESR could be an indicator of the severity of surgical stress.
  description: CD4 to CD8 ratio could be an indicator of the severity of surgical stress.
  arm group label: Laparoscopic surgery
  arm group type: Experimental
  description: The patients in this group will undergo laparoscopic surgery.
  arm group label: Robotic surgery
  arm group type: Active Comparator
  description: The patients in this group will undergo robotic surgery.
  intervention type: Procedure
  intervention name: Colectomy with NOSE procedure
  description: The specimen will be extract from the anus.
  arm group label: Laparoscopic surgery
  arm group label: Robotic surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jin-Tung LIANG, MD
  role: Study Chair
  affiliation: National Taiwan University Hospital
  last name: Jin-Tung LIANG, MD
  phone: 886-9-72651432
  email: jintung@ntu.edu.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms