<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/NCT02978989</url>
  </required_header>
  <id_info>
    <org_study_id>SSGB-1</org_study_id>
    <nct_id>NCT02978989</nct_id>
  </id_info>
  <brief_title>Solo and Non-solo Approach for Laparoscopic Cholecystectomy</brief_title>
  <acronym>SOLOGB</acronym>
  <official_title>A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daejeon St. Mary's hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daejeon St. Mary's hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is&#xD;
      defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing&#xD;
      consecutive non-solo procedures conducted by a surgeon in the presence or absence of human&#xD;
      assistant(s).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera&#xD;
      assistant, and other instrument assistant. Recent advancement of technology made it possible&#xD;
      to develop the conveniently adjustable holders for camera and other laparoscopic instruments.&#xD;
      The application of these instruments enables &quot;solo-surgery&quot; wherein an operation is driven by&#xD;
      single surgeon. During surgery, human assistant(s) are helpful because of their instant&#xD;
      assistance according to the operation's need. Therefore, the utilization of instruments&#xD;
      instead of human assistants would be cumbersome. However, the utilization of instruments&#xD;
      would be helpful by enabling operation-driven repositioning of the camera and instrument(s).&#xD;
      Currently, no attempt has been made to objectively compare the merits and demerits of these&#xD;
      two procedures. Therefore, this study was conducted to determine the safety and feasibility&#xD;
      of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to&#xD;
      laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a&#xD;
      surgeon in the presence or absence of human assistant(s).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operation time</measure>
    <time_frame>day 1</time_frame>
    <description>Operation time correlates with surgical difficulity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>day 3</time_frame>
    <description>Daily pain scores are assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cholecystectomy, Laparoscopic</condition>
  <arm_group>
    <arm_group_label>LC &amp; nonsolo approach</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The surgical intervention is nonsolo LC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LC &amp; solo approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgical intervention is solo LC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>nonsolo LC</intervention_name>
    <description>This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.</description>
    <arm_group_label>LC &amp; nonsolo approach</arm_group_label>
    <other_name>Nonsolo laparoscopic cholecystectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>solo LC</intervention_name>
    <description>This patient is scheduled to undergo solo laparoscpic cholecystectomy.</description>
    <arm_group_label>LC &amp; solo approach</arm_group_label>
    <other_name>Solo laparoscopic cholecystectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patients planed to undergo elective laparoscopic cholecystectomy&#xD;
&#xD;
          2. Benign gallbladder diseases requiring surgery&#xD;
&#xD;
          3. The patients who are indicated for single-port laparoscopic cholecystectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the patients with complicated cholecystitis&#xD;
&#xD;
          2. the patients with the gallbladder with a thickness more than 4mm.&#xD;
&#xD;
          3. the patients who are expected to have severe peritoneal adhesion.&#xD;
&#xD;
          4. the patients with malignant gallbladder diseases.&#xD;
&#xD;
          5. the patients whose operation appears to need human assistant(s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Say-June Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Say-June Kim, M.D.,Ph.D.</last_name>
    <phone>+821087737616</phone>
    <email>sayjunekim@gmail.com</email>
  </overall_contact>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daejeon St. Mary's hospital</investigator_affiliation>
    <investigator_full_name>Say-June Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic cholecystectomy</keyword>
  <keyword>Solo surgery</keyword>
  <keyword>Camera holder</keyword>
  <keyword>Cholecystitis</keyword>
  <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/NCT02978989
org study id: SSGB-1
nct id: NCT02978989
lead sponsor: 
has dmc: No
To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is
      defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing
      consecutive non-solo procedures conducted by a surgeon in the presence or absence of human
      assistant(s).
Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera
      assistant, and other instrument assistant. Recent advancement of technology made it possible
      to develop the conveniently adjustable holders for camera and other laparoscopic instruments.
      The application of these instruments enables "solo-surgery" wherein an operation is driven by
      single surgeon. During surgery, human assistant(s) are helpful because of their instant
      assistance according to the operation's need. Therefore, the utilization of instruments
      instead of human assistants would be cumbersome. However, the utilization of instruments
      would be helpful by enabling operation-driven repositioning of the camera and instrument(s).
      Currently, no attempt has been made to objectively compare the merits and demerits of these
      two procedures. Therefore, this study was conducted to determine the safety and feasibility
      of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to
      laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a
      surgeon in the presence or absence of human assistant(s).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Operation time
time frame: day 1
description: Operation time correlates with surgical difficulity.
measure: Pain score
time frame: day 3
description: Daily pain scores are assessed.
arm group label: LC & nonsolo approach
arm group type: Placebo Comparator
description: The surgical intervention is nonsolo LC.
arm group label: LC & solo approach
arm group type: Active Comparator
description: The surgical intervention is solo LC.
intervention type: Procedure
intervention name: nonsolo LC
description: This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.
arm group label: LC & nonsolo approach
other name: Nonsolo laparoscopic cholecystectomy
intervention type: Procedure
intervention name: solo LC
description: This patient is scheduled to undergo solo laparoscpic cholecystectomy.
arm group label: LC & solo approach
other name: Solo laparoscopic cholecystectomy
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Say-June Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea
last name: Say-June Kim, M.D.,Ph.D.
phone: +821087737616
email: sayjunekim@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Daejeon St. Mary's hospital
investigator full name: Say-June Kim
investigator title: Professor
sharing ipd: No