<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/NCT03250221</url>
  </required_header>
  <id_info>
    <org_study_id>106024-E</org_study_id>
    <nct_id>NCT03250221</nct_id>
  </id_info>
  <brief_title>Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures</brief_title>
  <official_title>Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic&#xD;
      myomectomy and laparoscopic myomectomy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominal drainage amount</measure>
    <time_frame>1 day</time_frame>
    <description>Postoperative day 1 abdominal drainage amount</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>1 day</time_frame>
    <description>Blood loss during surgeries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical time</measure>
    <time_frame>1 day</time_frame>
    <description>Surgical time</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Myomectomy</condition>
  <arm_group>
    <arm_group_label>Robotic or laparoscopic myomectomy</arm_group_label>
    <description>Women who received robotic or laparoscopic myomectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>barbed sutures</intervention_name>
    <description>Use of the barbed sutures for robotic or laparoscopic myomectomy</description>
    <arm_group_label>Robotic or laparoscopic myomectomy</arm_group_label>
    <other_name>V-Loc</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vicryl@ suture</intervention_name>
    <description>Use of Vicryl@ suture for robotic or laparoscopic myomectomy</description>
    <arm_group_label>Robotic or laparoscopic myomectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who underwent robotic myomectomy and conventional laparoscopic myomectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women who underwent robotic myomectomy and conventional laparoscopic myomectomy in&#xD;
             the Department of Obstetrics &amp; Gynecology of Far Eastern Memorial Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open myomectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheng-Mou Hsiao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Far Eastern Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Hsiao SM, Lin HH, Peng FS, Jen PJ, Hsiao CF, Tu FC. Comparison of robot-assisted laparoscopic myomectomy and traditional laparoscopic myomectomy. J Obstet Gynaecol Res. 2013 May;39(5):1024-9. doi: 10.1111/j.1447-0756.2012.02073.x. Epub 2013 Feb 4.</citation>
    <PMID>23379670</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief, Department of Obstetrics &amp; Gynecology, Far Eastern Memorial Hospital</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/NCT03250221
org study id: 106024-E
nct id: NCT03250221
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy
The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic
      myomectomy and laparoscopic myomectomy
observational model: Cohort
time perspective: Retrospective
measure: Abdominal drainage amount
time frame: 1 day
description: Postoperative day 1 abdominal drainage amount
measure: Blood loss
time frame: 1 day
description: Blood loss during surgeries
measure: Surgical time
time frame: 1 day
description: Surgical time
arm group label: Robotic or laparoscopic myomectomy
description: Women who received robotic or laparoscopic myomectomy
intervention type: Device
intervention name: barbed sutures
description: Use of the barbed sutures for robotic or laparoscopic myomectomy
arm group label: Robotic or laparoscopic myomectomy
other name: V-Loc
intervention type: Device
intervention name: Vicryl@ suture
description: Use of Vicryl@ suture for robotic or laparoscopic myomectomy
arm group label: Robotic or laparoscopic myomectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sheng-Mou Hsiao, MD
role: Principal Investigator
affiliation: Far Eastern Memorial Hospital
facility: 
country: Taiwan
citation: Hsiao SM, Lin HH, Peng FS, Jen PJ, Hsiao CF, Tu FC. Comparison of robot-assisted laparoscopic myomectomy and traditional laparoscopic myomectomy. J Obstet Gynaecol Res. 2013 May;39(5):1024-9. doi: 10.1111/j.1447-0756.2012.02073.x. Epub 2013 Feb 4.
PMID: 23379670
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital