<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/NCT03265301</url>
  </required_header>
  <id_info>
    <org_study_id>HSIU</org_study_id>
    <nct_id>NCT03265301</nct_id>
  </id_info>
  <brief_title>Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities</brief_title>
  <official_title>Corrective Office Hysteroscopic Surgery Versus Conventional Hysteroscopy in Treatment of Intrauterine Abnormalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      With the ongoing developments in the field of hysteroscopy during the past 15 years,&#xD;
      hysteroscopic surgery is becoming safer and less invasive for the patient. Improved&#xD;
      technology has enabled surgeons to perform many operative procedures in an ambulatory setting&#xD;
      without significant patient discomfort and with potentially significant cost savings.&#xD;
&#xD;
      Office operative hysteroscopy (see and treat hysteroscopy) reduces the distinction between a&#xD;
      diagnostic and an operative procedure, shifting the focus in health care away from inpatient&#xD;
      diagnosis and treatment. The development of smaller-diameter hysteroscopes with&#xD;
      continuous-flow system features and working channels, through which operative instruments can&#xD;
      be introduced, has made it possible to treat some uterine and cervical diseases without the&#xD;
      traditional need for cervical dilation or general anesthesia.&#xD;
&#xD;
      Use of specially designed hysteroscopic 5F mechanical instruments (e.g., scissors, biopsy&#xD;
      cup, graspers, and corkscrews) has long been the only way to perform operative procedures in&#xD;
      an ambulatory setting. However, although grasping forceps and scissors are excellent for&#xD;
      treating adhesions, cervical polyps, and endometrial polyps smaller than or the same size as&#xD;
      the larger endometrial polyps, or thick lesions (e.g., submucous fibroids) were difficult to&#xD;
      treat successfully using such miniature, fragile instruments and without cervical dilation.&#xD;
&#xD;
      An important technologic advance occurred in 1997 with the introduction of a versatile&#xD;
      bipolar electrosurgery system dedicated to hysteroscopy, the Gynecare VersaPoint (Ethicon,&#xD;
      Inc., Somerville, NJ, USA), which represents a key point in the history of office operative&#xD;
      hysteroscopy. With the use of 5F bipolar electrodes, the number of pathologic conditions&#xD;
      treated using office operative hysteroscopy has increased tremendously, reducing the use of&#xD;
      the resectoscope and the operating room to a smaller number of cases.&#xD;
&#xD;
      More recently, a new generation of electrical generators, allowing the use of bipolar energy&#xD;
      on miniaturized electrodes, has been presented (Autocon 400 II; Karl Storz Endoscopy,&#xD;
      Tuttlingen, Germany). The main advantage of these instruments is that they are reusable,&#xD;
      thereby reducing the costs of office operative as those described for the Versapoint system.&#xD;
&#xD;
      The feasibility of ambulatory uterine surgery is not just dependent on recent technological&#xD;
      advances in instrumentation such as miniaturization of equipment, but also the favorable&#xD;
      anatomical characteristics of the uterus itself. The sensitive innervations of the uterus&#xD;
      originate in the myometrium and extend to the outer serosal surface, whereas the endometrium&#xD;
      and any fibrotic tissue within the cavity are less sensitive. Thus, procedures can be carried&#xD;
      out without the use of analgesia or anesthesia.&#xD;
&#xD;
      However, a careful operative technique is of paramount importance, in particular, avoiding&#xD;
      inadvertent deep penetration of the superficial myometrium when resecting lesions such as&#xD;
      polyps, maintaining the lowest possible distension pressures, and expediting procedures&#xD;
      through efficient surgical techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The randomization could not be done&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Number of uterine abnormalities which will be treated successfully by office and conventional hysteroscopy</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hysteroscopy</condition>
  <arm_group>
    <arm_group_label>Office hysteroscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional hysteroscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hysteroscopy</intervention_name>
    <description>Includes Video set up, mini-hysteroscope system, continuous inflow and outflow, rod lens or fiber optic lens Zero to 30 degree angle and mechanical instruments (Scissors,Graspers , Cup biopsy forceps and bipolar instruments)</description>
    <arm_group_label>Conventional hysteroscopy</arm_group_label>
    <arm_group_label>Office hysteroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Office hysteroscopy</intervention_name>
    <description>will be done in out patient clinic without anesthesia</description>
    <arm_group_label>Office hysteroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional hysteroscopy</intervention_name>
    <description>will be done in operative room under general anesthesia</description>
    <arm_group_label>Conventional hysteroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infertile women&#xD;
&#xD;
          -  women with recurrent pregnancy loss&#xD;
&#xD;
          -  suspected intrauterine abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Normal endometrial cavity&#xD;
&#xD;
          -  Endometrial pathologies like polypi or submucous myomata.&#xD;
&#xD;
          -  Extensive intrauterine synechiae&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 19, 2022</last_update_submitted>
  <last_update_submitted_qc>November 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT03265301
org study id: HSIU
nct id: NCT03265301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With the ongoing developments in the field of hysteroscopy during the past 15 years,
      hysteroscopic surgery is becoming safer and less invasive for the patient. Improved
      technology has enabled surgeons to perform many operative procedures in an ambulatory setting
      without significant patient discomfort and with potentially significant cost savings.

      Office operative hysteroscopy (see and treat hysteroscopy) reduces the distinction between a
      diagnostic and an operative procedure, shifting the focus in health care away from inpatient
      diagnosis and treatment. The development of smaller-diameter hysteroscopes with
      continuous-flow system features and working channels, through which operative instruments can
      be introduced, has made it possible to treat some uterine and cervical diseases without the
      traditional need for cervical dilation or general anesthesia.

      Use of specially designed hysteroscopic 5F mechanical instruments (e.g., scissors, biopsy
      cup, graspers, and corkscrews) has long been the only way to perform operative procedures in
      an ambulatory setting. However, although grasping forceps and scissors are excellent for
      treating adhesions, cervical polyps, and endometrial polyps smaller than or the same size as
      the larger endometrial polyps, or thick lesions (e.g., submucous fibroids) were difficult to
      treat successfully using such miniature, fragile instruments and without cervical dilation.

      An important technologic advance occurred in 1997 with the introduction of a versatile
      bipolar electrosurgery system dedicated to hysteroscopy, the Gynecare VersaPoint (Ethicon,
      Inc., Somerville, NJ, USA), which represents a key point in the history of office operative
      hysteroscopy. With the use of 5F bipolar electrodes, the number of pathologic conditions
      treated using office operative hysteroscopy has increased tremendously, reducing the use of
      the resectoscope and the operating room to a smaller number of cases.

      More recently, a new generation of electrical generators, allowing the use of bipolar energy
      on miniaturized electrodes, has been presented (Autocon 400 II; Karl Storz Endoscopy,
      Tuttlingen, Germany). The main advantage of these instruments is that they are reusable,
      thereby reducing the costs of office operative as those described for the Versapoint system.

      The feasibility of ambulatory uterine surgery is not just dependent on recent technological
      advances in instrumentation such as miniaturization of equipment, but also the favorable
      anatomical characteristics of the uterus itself. The sensitive innervations of the uterus
      originate in the myometrium and extend to the outer serosal surface, whereas the endometrium
      and any fibrotic tissue within the cavity are less sensitive. Thus, procedures can be carried
      out without the use of analgesia or anesthesia.

      However, a careful operative technique is of paramount importance, in particular, avoiding
      inadvertent deep penetration of the superficial myometrium when resecting lesions such as
      polyps, maintaining the lowest possible distension pressures, and expediting procedures
      through efficient surgical techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of uterine abnormalities which will be treated successfully by office and conventional hysteroscopy
time frame: 1 month
arm group label: Office hysteroscopy
arm group type: Other
arm group label: Conventional hysteroscopy
arm group type: Other
intervention type: Procedure
intervention name: Hysteroscopy
description: Includes Video set up, mini-hysteroscope system, continuous inflow and outflow, rod lens or fiber optic lens Zero to 30 degree angle and mechanical instruments (Scissors,Graspers , Cup biopsy forceps and bipolar instruments)
arm group label: Conventional hysteroscopy
arm group label: Office hysteroscopy
intervention type: Procedure
intervention name: Office hysteroscopy
description: will be done in out patient clinic without anesthesia
arm group label: Office hysteroscopy
intervention type: Procedure
intervention name: Conventional hysteroscopy
description: will be done in operative room under general anesthesia
arm group label: Conventional hysteroscopy
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Lecturer
mesh term: Congenital Abnormalities
sharing ipd: Undecided