<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/NCT02197728</url>
  </required_header>
  <id_info>
    <org_study_id>13-326</org_study_id>
    <nct_id>NCT02197728</nct_id>
  </id_info>
  <brief_title>Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy</brief_title>
  <official_title>Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy&#xD;
      reduces operative time (from skin incision to detachment of the uterus) and lateral termal&#xD;
      damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine&#xD;
      manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all&#xD;
      aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy,&#xD;
      thereby hastening electrosurgical transection, reducing activation time and reduce lateral&#xD;
      thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished,&#xD;
      due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which&#xD;
      also affects speed of transection, electrosurgical device activation time and lateral thermal&#xD;
      damage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Detachment of the uterus</measure>
    <time_frame>45 minutes to 3 hours</time_frame>
    <description>Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thermal Damage</measure>
    <time_frame>2 weeks post surgery</time_frame>
    <description>Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colpotomy</measure>
    <time_frame>3 minutes to 20 minutes</time_frame>
    <description>Time from first monopolar energy activation to completion of colpotomy. Operative times are routinely collected by operating room nursing staff.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Loss</measure>
    <time_frame>45 minutes to 3 hours</time_frame>
    <description>Total amount of blood lost throughout surgery. Measured in cc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>24h post surgery</time_frame>
    <description>Amount of post operative pain measured using a pain sensitivity scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manipulator Installment</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Laparoscopic Hysterectomy for Benign Conditions</condition>
  <arm_group>
    <arm_group_label>Hohl uterine manipulator ®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colpo-Probe™ Vaginal Fornix Delineator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy</intervention_name>
    <arm_group_label>Colpo-Probe™ Vaginal Fornix Delineator</arm_group_label>
    <arm_group_label>Hohl uterine manipulator ®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women aged over 18 years, scheduled for a laparoscopic hysterectomy for a benign&#xD;
             disorder will be asked to participate and included after written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  if uterine size exceeds 20 weeks of gestation&#xD;
&#xD;
          -  or if the uterus could be removed by a vaginal approach&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guylaine Lefebvre, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael´s Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>May 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy</keyword>
  <!-- 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/NCT02197728
org study id: 13-326
nct id: NCT02197728
lead sponsor: 
has dmc: No
We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy
      reduces operative time (from skin incision to detachment of the uterus) and lateral termal
      damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine
      manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all
      aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy,
      thereby hastening electrosurgical transection, reducing activation time and reduce lateral
      thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished,
      due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which
      also affects speed of transection, electrosurgical device activation time and lateral thermal
      damage.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Detachment of the uterus
time frame: 45 minutes to 3 hours
description: Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.
measure: Thermal Damage
time frame: 2 weeks post surgery
description: Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.
measure: Colpotomy
time frame: 3 minutes to 20 minutes
description: Time from first monopolar energy activation to completion of colpotomy. Operative times are routinely collected by operating room nursing staff.
measure: Blood Loss
time frame: 45 minutes to 3 hours
description: Total amount of blood lost throughout surgery. Measured in cc.
measure: Pain
time frame: 24h post surgery
description: Amount of post operative pain measured using a pain sensitivity scale.
measure: Manipulator Installment
time frame: intraoperative
arm group label: Hohl uterine manipulator ®
arm group type: Active Comparator
description: Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®
arm group label: Colpo-Probe™ Vaginal Fornix Delineator
arm group type: Active Comparator
description: Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator
intervention type: Device
intervention name: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
arm group label: Colpo-Probe™ Vaginal Fornix Delineator
arm group label: Hohl uterine manipulator ®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guylaine Lefebvre, MD
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
responsible party type: Sponsor