<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/NCT02248194</url>
  </required_header>
  <id_info>
    <org_study_id>Tactile ablation</org_study_id>
    <nct_id>NCT02248194</nct_id>
  </id_info>
  <brief_title>Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding</brief_title>
  <acronym>TEA</acronym>
  <official_title>Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mostafa Hussein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood&#xD;
      ﬂow and heavy menstrual bleeding affects up to 30% of women at some time during their&#xD;
      reproductive years. Abnormal menstruation can be due to conditions such as pregnancy&#xD;
      complication uterine fibroids and adenomyosis, but in a large proportion of cases, the&#xD;
      etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding&#xD;
      (DUB). Treatment options for DUB include symptomatic medical treatment or surgery,&#xD;
      traditionally hysterectomy.&#xD;
&#xD;
      Hysteroscopically guided endometrial ablation methods have been shown to be effective and&#xD;
      safe alternatives to hysterectomy for management of DUB. These methods require particular&#xD;
      skills and experience and a long learning curve to be performed effectively and safely.&#xD;
&#xD;
      Through the past three decades DUB patients in Assiut university hospital were treated with&#xD;
      either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges&#xD;
      during transcervical resection of the endometrium or rollerball coagulation, we used to shift&#xD;
      to thermal balloon as backup method . However, expensive uterine balloon could not&#xD;
      infrequently be afforded because of financial constrains and limited health resources .&#xD;
      Therefore, another method was used as backup for hysteroscopic failures. It was first tried&#xD;
      via insulating the conventional double-ended uterine curette then through a specially&#xD;
      designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar&#xD;
      to the dilatation and curettage procedure both principally and practically. Hence, the basic&#xD;
      requirements for its performance are the general awareness with electrosurgical principles&#xD;
      and adequate experience in performing dilatation and curettage. TEA is done by specially&#xD;
      designed tactile diathermy probe that carried the job of electrosurgical ablation without&#xD;
      hysteroscopy or distension media first in an experimental session that clearly clarified the&#xD;
      reproducibility of the depth of thermal damage and safety of the tactile electrosurgical&#xD;
      ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term&#xD;
      outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done&#xD;
      under laparoscopic monitoring.&#xD;
&#xD;
      The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach&#xD;
      for treatment of DUB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</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>Satisfaction with the treatment at 12 month follow up</measure>
    <time_frame>12 moth</time_frame>
    <description>Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in menstrual status.</measure>
    <time_frame>At 3, 6, 9, and12 months pot operatve.</time_frame>
    <description>Menstrual status will be reported as&#xD;
Normal menstrual flow.&#xD;
Light menstrual bleeding.&#xD;
Heavy menstrual bleeding.&#xD;
The need for hysterectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of treatment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Acceptability of the procedure will be assessed in 3- point scale as cure or acceptable improvement in symptoms, treatment acceptable and would recommend treatment to others or not acceptable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health related quality of life</measure>
    <time_frame>At 3, 6, 9, and 12 months post operative.</time_frame>
    <description>Health-related quality of life parameters will be completed using&#xD;
Short form-12 (SF12).&#xD;
Life style questionnaires including Work affection will be measured by the number of days absence from the work due to menses as following, non ,non but work suffer, 1 day and &gt;2 days.&#xD;
sexual life affection will be measured in two point as no or yes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in operative time between the two groups in minutes.</measure>
    <time_frame>0-60 minutes</time_frame>
    <description>Difference in operative time is calculated using a stop watch.The zero minute is the time of starting the procedure. The stop watch is on at the zero minute then sopped at the end of the procedure.time of anesthesia is not included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reporting of any intro-operative complications.</measure>
    <time_frame>0-60 minutes.</time_frame>
    <description>Intro-operative complications includes&#xD;
Cervical laceration.&#xD;
Perforation of the uterus.&#xD;
Hemorrhage&#xD;
Fluid overload.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reporting of any technical complications.</measure>
    <time_frame>0-60 minutes</time_frame>
    <description>Technical complications for transcervical resection of the endometrium (TCRE) includes&#xD;
Poor uterine distention.&#xD;
Slow clearance of the debris.&#xD;
Inefficient cutting.&#xD;
Poor visualization.&#xD;
problem of diathermy.&#xD;
Problems with the camera.&#xD;
problems with light source.&#xD;
Technical complications for tactile electrosurgical ablation (TEA) includes&#xD;
Insulation problem.&#xD;
Connection problem.&#xD;
Inefficient diathermy power.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in post-operative pain score using visual analogue scale between the two groups.</measure>
    <time_frame>4 hours.</time_frame>
    <description>Difference in post-operative pain score using visual analogue scale from 1-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.</measure>
    <time_frame>28 days post operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay in days</measure>
    <time_frame>up to 2 days</time_frame>
    <description>Length of hospital stay in days is calculated from the day of operation till day of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the cost of the two surgical procedure.</measure>
    <time_frame>up to one hour.</time_frame>
    <description>Direct cost of the surgical procedure itself is calculated.The cost of the TCRE procedure will include the cost paid for the hysteroscopic unit and the cost of glycine used as distension media.The cost of the TEA procedure will include the cost of laparoscopy, the cost of TEA probe, and the cost of diagnostic hysteroscopy. The cost of the investigations, anesthesia, pre and post operative treatments will be excluded from analysis as they are the same for both groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Dysfunction Uterine Bleeding</condition>
  <arm_group>
    <arm_group_label>Group 1&quot;Tactile electrosurgical ablation&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endometrial ablation will be done by Tactile electrosurgical ablation probe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 &quot;Hysteroscopic endometrial ablation&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tactile electrosurgical ablation probe</intervention_name>
    <arm_group_label>Group 2 &quot;Hysteroscopic endometrial ablation&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hysteroscopic endometrial ablation</intervention_name>
    <arm_group_label>Group 1&quot;Tactile electrosurgical ablation&quot;</arm_group_label>
    <other_name>Transcervical resection of the endometrium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with dysfunctional uterine bleeding aged between 40 to 50 years&#xD;
&#xD;
          -  Unsuccessful medical treatment.&#xD;
&#xD;
          -  No intrauterine abnormalities.&#xD;
&#xD;
          -  Endometrial biopsy negative for atypia and cancer.&#xD;
&#xD;
          -  follicle stimulating hormone level not exceeds 30 mills-International unit&#xD;
&#xD;
          -  Family complete&#xD;
&#xD;
          -  Patients who are not candidate for hysterectomy because of medical or surgical risks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coexisting gynecological pathology (e.g. uterovaginal prolapsed, ovarian pathology,&#xD;
             pelvic inflammatory disease, cervical atypia).&#xD;
&#xD;
          -  Endometrial hyperplasia with atypia and cancer..&#xD;
&#xD;
          -  History or evidence of malignancy.&#xD;
&#xD;
          -  Hyperplasia in the endometrial biopsy.&#xD;
&#xD;
          -  Uterine size more than 12 weeks in size.&#xD;
&#xD;
          -  Women with caesarean or myomectomy scar&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Woman's Health Hospital-Assiut University.</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>January 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>December 30, 2015</last_update_submitted>
  <last_update_submitted_qc>December 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mostafa Hussein</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Dysfunction uterine bleeding</keyword>
  <keyword>Hysteroscopic endometrial ablation</keyword>
  <keyword>Tactile endometrial ablation</keyword>
  <keyword>Hysteroscopic difficulties</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Hemorrhage</mesh_term>
    <mesh_term>Metrorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT02248194
org study id: Tactile ablation
nct id: NCT02248194
lead sponsor: 
collaborator: 
has dmc: Yes
Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood
      ﬂow and heavy menstrual bleeding affects up to 30% of women at some time during their
      reproductive years. Abnormal menstruation can be due to conditions such as pregnancy
      complication uterine fibroids and adenomyosis, but in a large proportion of cases, the
      etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding
      (DUB). Treatment options for DUB include symptomatic medical treatment or surgery,
      traditionally hysterectomy.

      Hysteroscopically guided endometrial ablation methods have been shown to be effective and
      safe alternatives to hysterectomy for management of DUB. These methods require particular
      skills and experience and a long learning curve to be performed effectively and safely.

      Through the past three decades DUB patients in Assiut university hospital were treated with
      either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges
      during transcervical resection of the endometrium or rollerball coagulation, we used to shift
      to thermal balloon as backup method . However, expensive uterine balloon could not
      infrequently be afforded because of financial constrains and limited health resources .
      Therefore, another method was used as backup for hysteroscopic failures. It was first tried
      via insulating the conventional double-ended uterine curette then through a specially
      designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar
      to the dilatation and curettage procedure both principally and practically. Hence, the basic
      requirements for its performance are the general awareness with electrosurgical principles
      and adequate experience in performing dilatation and curettage. TEA is done by specially
      designed tactile diathermy probe that carried the job of electrosurgical ablation without
      hysteroscopy or distension media first in an experimental session that clearly clarified the
      reproducibility of the depth of thermal damage and safety of the tactile electrosurgical
      ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term
      outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done
      under laparoscopic monitoring.

      The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach
      for treatment of DUB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Satisfaction with the treatment at 12 month follow up
time frame: 12 moth
description: Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.
measure: Change in menstrual status.
time frame: At 3, 6, 9, and12 months pot operatve.
description: Menstrual status will be reported as
Normal menstrual flow.
Light menstrual bleeding.
Heavy menstrual bleeding.
The need for hysterectomy.
measure: Acceptability of treatment
time frame: 4 weeks
description: Acceptability of the procedure will be assessed in 3- point scale as cure or acceptable improvement in symptoms, treatment acceptable and would recommend treatment to others or not acceptable
measure: Changes in health related quality of life
time frame: At 3, 6, 9, and 12 months post operative.
description: Health-related quality of life parameters will be completed using
Short form-12 (SF12).
Life style questionnaires including Work affection will be measured by the number of days absence from the work due to menses as following, non ,non but work suffer, 1 day and >2 days.
sexual life affection will be measured in two point as no or yes.
measure: Difference in operative time between the two groups in minutes.
time frame: 0-60 minutes
description: Difference in operative time is calculated using a stop watch.The zero minute is the time of starting the procedure. The stop watch is on at the zero minute then sopped at the end of the procedure.time of anesthesia is not included.
measure: Reporting of any intro-operative complications.
time frame: 0-60 minutes.
description: Intro-operative complications includes
Cervical laceration.
Perforation of the uterus.
Hemorrhage
Fluid overload.
measure: Reporting of any technical complications.
time frame: 0-60 minutes
description: Technical complications for transcervical resection of the endometrium (TCRE) includes
Poor uterine distention.
Slow clearance of the debris.
Inefficient cutting.
Poor visualization.
problem of diathermy.
Problems with the camera.
problems with light source.
Technical complications for tactile electrosurgical ablation (TEA) includes
Insulation problem.
Connection problem.
Inefficient diathermy power.
measure: Difference in post-operative pain score using visual analogue scale between the two groups.
time frame: 4 hours.
description: Difference in post-operative pain score using visual analogue scale from 1-10.
measure: Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
time frame: 28 days post operative
measure: Length of hospital stay in days
time frame: up to 2 days
description: Length of hospital stay in days is calculated from the day of operation till day of discharge.
measure: Difference in the cost of the two surgical procedure.
time frame: up to one hour.
description: Direct cost of the surgical procedure itself is calculated.The cost of the TCRE procedure will include the cost paid for the hysteroscopic unit and the cost of glycine used as distension media.The cost of the TEA procedure will include the cost of laparoscopy, the cost of TEA probe, and the cost of diagnostic hysteroscopy. The cost of the investigations, anesthesia, pre and post operative treatments will be excluded from analysis as they are the same for both groups.
arm group label: Group 1"Tactile electrosurgical ablation"
arm group type: Experimental
description: Endometrial ablation will be done by Tactile electrosurgical ablation probe.
arm group label: Group 2 "Hysteroscopic endometrial ablation"
arm group type: Active Comparator
description: Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.
intervention type: Device
intervention name: Tactile electrosurgical ablation probe
arm group label: Group 2 "Hysteroscopic endometrial ablation"
intervention type: Device
intervention name: Hysteroscopic endometrial ablation
arm group label: Group 1"Tactile electrosurgical ablation"
other name: Transcervical resection of the endometrium
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Mostafa Hussein
investigator title: Dr
mesh term: Uterine Hemorrhage
mesh term: Metrorrhagia
mesh term: Hemorrhage