<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/NCT01679548</url>
  </required_header>
  <id_info>
    <org_study_id>LESS-H</org_study_id>
    <nct_id>NCT01679548</nct_id>
  </id_info>
  <brief_title>Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease</brief_title>
  <official_title>Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</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>
      To compare the efficacy between single-port and three-port laparoscopic assisted vaginal&#xD;
      hysterectomy in patients with benign or preinvasive uterine disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster&#xD;
      recovery rate than three-port LAVH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2011</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative hospital stay</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>Postoperative pain was recorded using the Visual Analog Pain Scale (VAS), scored from 1 to 10 (0 is no pain and 10 is agonizing pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative analgesics requirement</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>Whenever patients requested additional analgesia, they were administered parenterally.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operating time</measure>
    <time_frame>1 day (immediately ater surgery)</time_frame>
    <description>skin to skin operation time was recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion requirement and amount</measure>
    <time_frame>within 1 week after surgery</time_frame>
    <description>Transfusion requirement and amount were recorede</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intra and postoperative complication</measure>
    <time_frame>within 1 months after surgery</time_frame>
    <description>intra and post operative complications were recorede</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">424</enrollment>
  <condition>Benign or Preinvasive Uterine Disease</condition>
  <arm_group>
    <arm_group_label>Single-port LAVH group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single-port laparoscopic assisted vaginal hysterectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three-port LAVH group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>three-port laparoscopic assisted vaginal hysterectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-port LAVH</intervention_name>
    <description>LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.</description>
    <arm_group_label>Single-port LAVH group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Three-port LAVH</intervention_name>
    <description>Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.</description>
    <arm_group_label>Three-port LAVH group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who undergo laparoscopic assisted vaginal hysterectomy due to following&#xD;
             gynecologic disease&#xD;
&#xD;
               1. uterine leiomyoma&#xD;
&#xD;
               2. uterine adenomyosis&#xD;
&#xD;
               3. Endometrial hyperplasia&#xD;
&#xD;
               4. cervical intraepithelial neoplasia including carcinoma in situ&#xD;
&#xD;
               5. Dysfunctional uterine bleeding&#xD;
&#xD;
               6. Other benign gynecologic disease requiring hysterectomy&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status classification I-II&#xD;
&#xD;
          -  Patient who have signed an written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled medical disease&#xD;
&#xD;
          -  Active infectious disease&#xD;
&#xD;
          -  Previous pelvic radiation therapy&#xD;
&#xD;
          -  Patient who requiring further procedure excluding hysterectomy, unilateral or&#xD;
             bilateral salpingooophorectomy / salpingectomy / oophorectomy&#xD;
&#xD;
          -  Patient who undergoes subtotal hysterectomy&#xD;
&#xD;
          -  Patient who have other pain source excluding gynecologic disease&#xD;
&#xD;
          -  Pregnancy and lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Joo-Hyun Nam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>LESS</keyword>
  <keyword>Benign uterine disease</keyword>
  <keyword>LAVH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Diseases</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/NCT01679548
org study id: LESS-H
nct id: NCT01679548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the efficacy between single-port and three-port laparoscopic assisted vaginal
      hysterectomy in patients with benign or preinvasive uterine disease
This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster
      recovery rate than three-port LAVH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative hospital stay
time frame: within 1 week after surgery
description: The primary endpoint was to compare average length of postoperative hospital stay and the ratio of patients discharged within 2 days after surgery between LESS and conventional groups.
measure: postoperative pain
time frame: within 1 week after surgery
description: Postoperative pain was recorded using the Visual Analog Pain Scale (VAS), scored from 1 to 10 (0 is no pain and 10 is agonizing pain)
measure: postoperative analgesics requirement
time frame: within 1 week after surgery
description: Whenever patients requested additional analgesia, they were administered parenterally.
measure: operating time
time frame: 1 day (immediately ater surgery)
description: skin to skin operation time was recorded
measure: Transfusion requirement and amount
time frame: within 1 week after surgery
description: Transfusion requirement and amount were recorede
measure: intra and postoperative complication
time frame: within 1 months after surgery
description: intra and post operative complications were recorede
arm group label: Single-port LAVH group
arm group type: Experimental
description: single-port laparoscopic assisted vaginal hysterectomy
arm group label: Three-port LAVH group
arm group type: Active Comparator
description: three-port laparoscopic assisted vaginal hysterectomy
intervention type: Procedure
intervention name: Single-port LAVH
description: LESS LAVH was performed using a commercially available four-channel, single-port system. A rigid, 0-degree, 5 mm laparoscope was used.
arm group label: Single-port LAVH group
intervention type: Procedure
intervention name: Three-port LAVH
description: Conventional LAVH was performed using three ports; a 12, 10, and 5-mm port was placed in the umbilicus, left lower quadrant, and suprapubic area, respectively. A rigid, 0-degree, 12 mm laparoscope was introduced through 12mm port of umbilicus.
arm group label: Three-port LAVH group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Joo-Hyun Nam, M.D., Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Joo-Hyun Nam
investigator title: Professor
mesh term: Uterine Diseases
sharing ipd: Undecided