<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/NCT02185586</url>
  </required_header>
  <id_info>
    <org_study_id>2014-21</org_study_id>
    <secondary_id>2014-21</secondary_id>
    <nct_id>NCT02185586</nct_id>
  </id_info>
  <brief_title>A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy</brief_title>
  <official_title>A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China-Japan Friendship Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account&#xD;
      to this new method, the three incisions are all located on the lower abdominal, theoretically&#xD;
      it could get more beautiful outlook and less stress response than traditional laparoscopic&#xD;
      cholecystectomy(two of the three incisions located on upper abdomen) or single port&#xD;
      laparoscopic cholecystectomy(one large incision located on umbilicus).&#xD;
&#xD;
      We plan to conduct a randomized controlled trial to compare those there methods of&#xD;
      laparoscopic cholecystectomy, in order to find out if there will be some advantages of this&#xD;
      new method,such as in lowering the stress response,reducing impact on respiration, relieving&#xD;
      post-operation pain and improving appearance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systematic inflammatory response caused by the surgical trauma</measure>
    <time_frame>one day before the operation,8 hours after the operation,one day after the operation</time_frame>
    <description>Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cosmesis and body image score</measure>
    <time_frame>1 and 3 months after the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary function</measure>
    <time_frame>one day before the operation, one day after the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operation pain score (visual analog scale, VAS)</measure>
    <time_frame>12 and 24 hours after the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-item health survey</measure>
    <time_frame>3 months after the operation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>perioperative indexes</measure>
    <time_frame>perioperative period</time_frame>
    <description>operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Gallbladder Stone</condition>
  <condition>Gallbladder Polyp</condition>
  <arm_group>
    <arm_group_label>LALC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lower abdominal laparoscopic cholecystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single laparoscopic cholecystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UALC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>upper abdominal laparoscopic cholecystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic cholecystectomy</intervention_name>
    <arm_group_label>LALC</arm_group_label>
    <arm_group_label>SLC</arm_group_label>
    <arm_group_label>UALC</arm_group_label>
    <other_name>lower abdominal three-port laparoscopic cholecystectomy</other_name>
    <other_name>single port laparoscopic cholecystectomy</other_name>
    <other_name>upper abdominal three-port laparoscopic cholecystectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age from 18 to 70 years old&#xD;
&#xD;
          -  benign diseases of gallbladder&#xD;
&#xD;
          -  selective cholecystectomy&#xD;
&#xD;
          -  Capable to read and write&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  accept upper abdominal operation before&#xD;
&#xD;
          -  acute cholecystitis&#xD;
&#xD;
          -  with serious heart or pulmonary diseases&#xD;
&#xD;
          -  with diseases of immune system&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  can not understand the research purposes&#xD;
&#xD;
          -  relatives of researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chen Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China-Japan Friednship Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of hepatobiliary surgery,China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Li Xu</investigator_full_name>
    <investigator_title>Department of hepatobiliary surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</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/NCT02185586
org study id: 2014-21
secondary id: 2014-21
nct id: NCT02185586
lead sponsor: 
has dmc: Yes
We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account
      to this new method, the three incisions are all located on the lower abdominal, theoretically
      it could get more beautiful outlook and less stress response than traditional laparoscopic
      cholecystectomy(two of the three incisions located on upper abdomen) or single port
      laparoscopic cholecystectomy(one large incision located on umbilicus).

      We plan to conduct a randomized controlled trial to compare those there methods of
      laparoscopic cholecystectomy, in order to find out if there will be some advantages of this
      new method,such as in lowering the stress response,reducing impact on respiration, relieving
      post-operation pain and improving appearance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Systematic inflammatory response caused by the surgical trauma
time frame: one day before the operation,8 hours after the operation,one day after the operation
description: Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
measure: Cosmesis and body image score
time frame: 1 and 3 months after the operation
measure: pulmonary function
time frame: one day before the operation, one day after the operation
measure: Post-operation pain score (visual analog scale, VAS)
time frame: 12 and 24 hours after the operation
measure: 36-item health survey
time frame: 3 months after the operation
measure: perioperative indexes
time frame: perioperative period
description: operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay
arm group label: LALC
arm group type: Experimental
description: lower abdominal laparoscopic cholecystectomy
arm group label: SLC
arm group type: Experimental
description: single laparoscopic cholecystectomy
arm group label: UALC
arm group type: Placebo Comparator
description: upper abdominal laparoscopic cholecystectomy
intervention type: Procedure
intervention name: laparoscopic cholecystectomy
arm group label: LALC
arm group label: SLC
arm group label: UALC
other name: lower abdominal three-port laparoscopic cholecystectomy
other name: single port laparoscopic cholecystectomy
other name: upper abdominal three-port laparoscopic cholecystectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chen Wang, MD
role: Principal Investigator
affiliation: China-Japan Friednship Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Li Xu
investigator title: Department of hepatobiliary surgery
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
sharing ipd: Undecided