<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/NCT03010813</url>
  </required_header>
  <id_info>
    <org_study_id>CREC Ref. No.: 2016.348</org_study_id>
    <nct_id>NCT03010813</nct_id>
  </id_info>
  <brief_title>A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery</brief_title>
  <official_title>A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, single center, multispecialty study that aimed to evaluate the&#xD;
      clinical feasibility and safety of single port surgery and NOTES (mainly transanal and&#xD;
      transoral surgery) using a novel single port robotic system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES)&#xD;
      are emerging minimally invasive surgery techniques which can further reduce patient trauma&#xD;
      and enhance recovery. However, the wider adoption of these techniques is hampered by the&#xD;
      limitation of instrumentation and technical difficulties. Robotic assistance may improve&#xD;
      surgical capabilities during single port surgery and NOTES by providing augmented motion&#xD;
      precision and manipulation dexterity.&#xD;
&#xD;
      Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES&#xD;
      (mainly transanal and transoral surgery) using a novel single port robotic system.&#xD;
&#xD;
      Design: Prospective, single center, multispecialty study consistent with a stage 1&#xD;
      (Innovation) study described in the Innovation, Development, Exploration, Assessment,&#xD;
      Long-term Study (IDEAL) framework.&#xD;
&#xD;
      Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for&#xD;
      single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the&#xD;
      inclusion and exclusion criteria will be recruited.&#xD;
&#xD;
      Intervention: Single port surgery and transanal/transoral surgery will be performed using the&#xD;
      novel single port robotic system.&#xD;
&#xD;
      Study Endpoints: Primary: conversion rate and perioperative complications. Secondary:&#xD;
      operative time, blood loss, pain scores, analgesic requirement, and length of stay.&#xD;
&#xD;
      Hypothesis: The prospective study will provide important information on the feasibility,&#xD;
      safety, and effectiveness of the novel single port robotic system in performing single port&#xD;
      surgery and NOTES in various surgical specialties. A positive study will provide supporting&#xD;
      evidence for continuing development of this new technology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perioperative complications</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores on a visual analog scale</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic requirement</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completeness of resection</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Pathologic examination of the resected specimen for completeness of resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection margins</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Pathologic examination of the resected specimen for resection margins positivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of lymph nodes harvested</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Pathologic examination of the resected specimen (malignant cases)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anal continence after transanal surgery</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal incontinence quality of life after transanal surgery</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary continence after radical prostatectomy</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After radical prostatectomy; assessed by recording the number of pads used per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Male sexual function after radical prostatectomy</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function after nephrectomy</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After nephrectomy; using renal function blood tests for urea and creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swallowing function after transoral robotic surgery (TORS)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After TORS; using the MD Anderson Dysphagia Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Voice function after TORS</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>After TORS; using the Voice Handicap Index (VHI) 30</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Urologic Neoplasms</condition>
  <condition>Urologic Diseases</condition>
  <condition>Nasopharyngeal Neoplasms</condition>
  <condition>Oropharyngeal Neoplasms</condition>
  <condition>Oral Neoplasms</condition>
  <condition>Hypopharyngeal Neoplasms</condition>
  <condition>Laryngeal Neoplasms</condition>
  <condition>ENT Diseases</condition>
  <arm_group>
    <arm_group_label>Novel single port robotic system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic single port surgery and NOTES</intervention_name>
    <description>Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery</description>
    <arm_group_label>Novel single port robotic system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES&#xD;
&#xD;
          1. Body mass index &lt;35 kg/m2&#xD;
&#xD;
          2. Suitable for minimally invasive surgery&#xD;
&#xD;
          3. Willingness to participate as demonstrated by giving informed consent&#xD;
&#xD;
        GENERAL EXCLUSION CRITERIA FOR ALL PROCEDURES&#xD;
&#xD;
          1. Contraindication to general anesthesia&#xD;
&#xD;
          2. Severe concomitant illness that drastically shortens life expectancy or increases risk&#xD;
             of therapeutic intervention&#xD;
&#xD;
          3. Untreated active infection&#xD;
&#xD;
          4. Noncorrectable coagulopathy&#xD;
&#xD;
          5. Presence of another malignancy or distant metastasis&#xD;
&#xD;
          6. Emergency surgery&#xD;
&#xD;
          7. Vulnerable population (e.g. mentally disabled, pregnancy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prince of Wales Hospital, The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Simon S. M. Ng</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Urologic Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
    <mesh_term>Laryngeal Neoplasms</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Mouth Neoplasms</mesh_term>
    <mesh_term>Hypopharyngeal Neoplasms</mesh_term>
    <mesh_term>Urologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03010813
org study id: CREC Ref. No.: 2016.348
nct id: NCT03010813
lead sponsor: 
has dmc: Yes
This is a prospective, single center, multispecialty study that aimed to evaluate the
      clinical feasibility and safety of single port surgery and NOTES (mainly transanal and
      transoral surgery) using a novel single port robotic system.
Background: Single port surgery and natural orifice transluminal endoscopic surgery (NOTES)
      are emerging minimally invasive surgery techniques which can further reduce patient trauma
      and enhance recovery. However, the wider adoption of these techniques is hampered by the
      limitation of instrumentation and technical difficulties. Robotic assistance may improve
      surgical capabilities during single port surgery and NOTES by providing augmented motion
      precision and manipulation dexterity.

      Objectives: To evaluate the clinical feasibility and safety of single port surgery and NOTES
      (mainly transanal and transoral surgery) using a novel single port robotic system.

      Design: Prospective, single center, multispecialty study consistent with a stage 1
      (Innovation) study described in the Innovation, Development, Exploration, Assessment,
      Long-term Study (IDEAL) framework.

      Subjects: Sixty consecutive patients with various benign/malignant pathologies indicated for
      single port colorectal/urologic surgery or transanal/transoral surgery who fulfilled all the
      inclusion and exclusion criteria will be recruited.

      Intervention: Single port surgery and transanal/transoral surgery will be performed using the
      novel single port robotic system.

      Study Endpoints: Primary: conversion rate and perioperative complications. Secondary:
      operative time, blood loss, pain scores, analgesic requirement, and length of stay.

      Hypothesis: The prospective study will provide important information on the feasibility,
      safety, and effectiveness of the novel single port robotic system in performing single port
      surgery and NOTES in various surgical specialties. A positive study will provide supporting
      evidence for continuing development of this new technology.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Conversion rate
time frame: Up to 1 month
description: An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery
measure: Perioperative complications
time frame: Up to 1 month
description: Complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification
measure: Operative time
time frame: Intraoperative
measure: Estimated blood loss
time frame: Up to 1 month
measure: Pain scores on a visual analog scale
time frame: Up to 1 month
measure: Analgesic requirement
time frame: Up to 1 month
measure: Length of hospital stay
time frame: Up to 1 month
measure: Completeness of resection
time frame: Up to 1 month
description: Pathologic examination of the resected specimen for completeness of resection
measure: Resection margins
time frame: Up to 1 month
description: Pathologic examination of the resected specimen for resection margins positivity
measure: Number of lymph nodes harvested
time frame: Up to 1 month
description: Pathologic examination of the resected specimen (malignant cases)
measure: Anal continence after transanal surgery
time frame: Up to 1 year
description: After transanal surgery; using the Cleveland Clinic Incontinence Score (Wexner's Score)
measure: Fecal incontinence quality of life after transanal surgery
time frame: Up to 1 year
description: After transanal surgery; using the validated Chinese version of the Fecal Incontinence Quality of Life Scale (FIQL)
measure: Urinary continence after radical prostatectomy
time frame: Up to 1 year
description: After radical prostatectomy; assessed by recording the number of pads used per day
measure: Male sexual function after radical prostatectomy
time frame: Up to 1 year
description: After radical prostatectomy; using the abridged version of the International Index of Erectile Dysfunction - erectile function domain score (IIEF-EF)
measure: Renal function after nephrectomy
time frame: Up to 1 year
description: After nephrectomy; using renal function blood tests for urea and creatinine
measure: Swallowing function after transoral robotic surgery (TORS)
time frame: Up to 1 year
description: After TORS; using the MD Anderson Dysphagia Inventory
measure: Voice function after TORS
time frame: Up to 1 year
description: After TORS; using the Voice Handicap Index (VHI) 30
arm group label: Novel single port robotic system
arm group type: Experimental
description: A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula
intervention type: Procedure
intervention name: Robotic single port surgery and NOTES
description: Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery
arm group label: Novel single port robotic system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Simon S. M. Ng
investigator title: Professor of Surgery
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Urologic Neoplasms
mesh term: Nasopharyngeal Neoplasms
mesh term: Laryngeal Neoplasms
mesh term: Oropharyngeal Neoplasms
mesh term: Mouth Neoplasms
mesh term: Hypopharyngeal Neoplasms
mesh term: Urologic Diseases
sharing ipd: No