<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/NCT01679509</url>
  </required_header>
  <id_info>
    <org_study_id>LESS-A</org_study_id>
    <nct_id>NCT01679509</nct_id>
  </id_info>
  <brief_title>Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease</brief_title>
  <official_title>Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the safety and efficacy between single-port and three-port adnexal surgery in&#xD;
      patients with benign ovarian and tubal disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">July 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative hospital stay</measure>
    <time_frame>within 1 week after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>within 1 week after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative analgesics requirement</measure>
    <time_frame>within 1 week after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>within 6 months aftr surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical stress response</measure>
    <time_frame>within 2 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operating time</measure>
    <time_frame>immediately ater surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transfusion requirement and amount</measure>
    <time_frame>within 1 week after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative complication</measure>
    <time_frame>within 1 months after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Benign Ovarian or Tubal Disease</condition>
  <arm_group>
    <arm_group_label>Single-port surgery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-port laparoscopic adnexal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three-port surgery group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three-port laparoscopic adnexal surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-port laparoscopic adnexal surgery</intervention_name>
    <arm_group_label>Single-port surgery group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Three-port laparoscopic adnexal surgery</intervention_name>
    <arm_group_label>Three-port surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who undergo laparoscopic adnexal surgery due to following benign adenxal&#xD;
             disease&#xD;
&#xD;
               1. Benign teratoma&#xD;
&#xD;
               2. Endometrioma&#xD;
&#xD;
               3. Mucinous cystadenoma&#xD;
&#xD;
               4. Serous cystadenoma&#xD;
&#xD;
               5. Benign Brenner tumor&#xD;
&#xD;
               6. Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)&#xD;
&#xD;
               7. paratubal cyst, parovarian cyst&#xD;
&#xD;
               8. Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian&#xD;
                  cancer syndrome&#xD;
&#xD;
               9. Other benign adnexal disease requiring surgery&#xD;
&#xD;
          -  American Society of Anesthesiologist Physical Status classification I-II.&#xD;
&#xD;
          -  Patient who have signed 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 requires further procedure excluding adnexal surgery&#xD;
&#xD;
          -  Patient who has other pain source excluding adnexal disease&#xD;
&#xD;
          -  Pregnant 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>
  <overall_contact>
    <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
    <phone>82-2-3010-3633</phone>
    <email>jhnam@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Universit of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joo-Hyun Nam, M.D., Ph.D.</last_name>
      <phone>82-2-3010-3633</phone>
      <email>jhnam@amc.seoul.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 27, 2017</last_update_submitted>
  <last_update_submitted_qc>May 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</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>
  <!-- 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/NCT01679509
org study id: LESS-A
nct id: NCT01679509
lead sponsor: 
has dmc: No
To compare the safety and efficacy between single-port and three-port adnexal surgery in
      patients with benign ovarian and tubal disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative hospital stay
time frame: within 1 week after surgery
measure: postoperative pain
time frame: within 1 week after surgery
measure: postoperative analgesics requirement
time frame: within 1 week after surgery
measure: quality of life
time frame: within 6 months aftr surgery
measure: surgical stress response
time frame: within 2 days after surgery
measure: operating time
time frame: immediately ater surgery
measure: transfusion requirement and amount
time frame: within 1 week after surgery
measure: postoperative complication
time frame: within 1 months after surgery
arm group label: Single-port surgery group
arm group type: Experimental
description: Single-port laparoscopic adnexal surgery
arm group label: Three-port surgery group
arm group type: Active Comparator
description: Three-port laparoscopic adnexal surgery
intervention type: Procedure
intervention name: Single-port laparoscopic adnexal surgery
arm group label: Single-port surgery group
intervention type: Procedure
intervention name: Three-port laparoscopic adnexal surgery
arm group label: Three-port surgery 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
last name: Joo-Hyun Nam, M.D., Ph.D.
phone: 82-2-3010-3633
email: jhnam@amc.seoul.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Joo-Hyun Nam
investigator title: Professor