<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/NCT03228654</url>
  </required_header>
  <id_info>
    <org_study_id>Obs3514</org_study_id>
    <nct_id>NCT03228654</nct_id>
  </id_info>
  <brief_title>Electrosurgical Unipolar Vessel Sealing in Vaginal Hysterectomy</brief_title>
  <official_title>Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof&#xD;
      the development of alternative treatments, the incidence of hysterectomy doesn't appear to be&#xD;
      declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined&#xD;
      approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients&#xD;
      with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy&#xD;
      for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be&#xD;
      performed in preference to abdominal hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot prospective randomized clinical trial will be conducted at Ain shams University&#xD;
      Maternity Hospital during the period from August 2016 to August 2018.&#xD;
&#xD;
      A sample size of 50 cases will be recruited from women presenting to the outpatient&#xD;
      gynecologic clinic of Ain Shams University Maternity Hospital planned to undergo vaginal&#xD;
      hysterectomy for benign cause. selected patients should be in age group from 40 to 70 years.&#xD;
      Uterus size should be &lt; 12 weeks with absence of significant scarring in the pelvis from&#xD;
      previous surgeries. Endometriosis, Adnexal mass, malignancy, thinned out cervix should be&#xD;
      excluded. After approval of the ethical committee , a detailed explanation of the procedure&#xD;
      will e informed to the participant &amp; her approval to be involved in the study, an informed&#xD;
      written consent will be taken. After that, included patients will be randomized into 2 groups&#xD;
      each one include 25 patients. First group includes women who will undergo vaginal&#xD;
      hysterectomy using monopolar electrocautery. Second group includes women who will undergo&#xD;
      vaginal hysterectomy using Purohit's technique. Principles of Purohit technique are 1.&#xD;
      Vaginal walls are incised by monopolar current(30-50W).2.A right angle forceps is used o&#xD;
      elevate, hook, stretch, spread and retract all the lateral attacements of uterus &amp; vessels&#xD;
      from their posterior aspects; tissues are coagulated using bipolar current (45 W) and divided&#xD;
      between the prongs of forceps. 3. conventional volume reduction maneuvers are used as&#xD;
      associated procedures in cases of large uteri to create the parauterine space for bipolar&#xD;
      forceps and scissors.&#xD;
&#xD;
      Meanwhile the principles for vaginal hysterectomy using unipolar electrocautery are 1.Vaginal&#xD;
      walls are incised by monopolar current(40 W) 2.A curved Bulldog clamp is applied just 0.5 cm&#xD;
      lateral to uterine border along its attachements all through the pedicles. Then unipolar&#xD;
      electrocautery (40 W) is applied to the pedicles along the lteral border of the uterus medial&#xD;
      to the artery with maximum thickness 1 cm. 3. Uterine vessels are individually secured. 4.&#xD;
      conventional volume reduction maneuvers are used as associated procedures in cases of large&#xD;
      uteri to create the parauterine space for bipolar forceps and scissors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No available device in the hospital to complete study&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>5 minutes after end if the procedure</time_frame>
    <description>assessment of blood loss by assessing blood loss amount in suction bottle as well as soaked guzes and towels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>5 minutes after end of the procedure</time_frame>
    <description>will be accounted from time of vaginal mucous membrane incision till closure of the vault.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>6 hours postoperative</time_frame>
    <description>pain scale will be used to assess pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>12 hours postoperative</time_frame>
    <description>pain scale will be used to assess pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>pain scale will be used to assess pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>number of days after the procedure the patient stay at the hospital</description>
  </secondary_outcome>
  <other_outcome>
    <measure>postoperative complication</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>bleeding</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative complication</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>burns</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative complication</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>haemtoma</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative complication</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>urinary tract infections</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative complication</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>surgical site infection</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative complication</measure>
    <time_frame>1 week after procedure</time_frame>
    <description>blood transfusion</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Vaginal Hysterectomy</condition>
  <arm_group>
    <arm_group_label>Unipolar electrocautery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vaginal hysterectomy using Unipolar electrocautery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Purohit's technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vaginal hysterectomy using Purohit's technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Unipolar Electrocautery sealing of vessels</intervention_name>
    <description>Vaginal walls are incised by monoplar current (40 W)&#xD;
A curved Bulldog Clamp is applied just 0.5 cm lateral to the uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lateral border of the uterus medial to the artery with maximum thickness 1 cm.&#xD;
uterine vessels are individually secured.&#xD;
Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space to approach the lateral attachements.</description>
    <arm_group_label>Unipolar electrocautery</arm_group_label>
    <other_name>Monopolar Electrocautery sealing of vessels</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Purohit technique for vaginal hysterectomy</intervention_name>
    <description>using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy</description>
    <arm_group_label>Purohit's technique</arm_group_label>
    <other_name>Bipolar electrosurgical sealing of vessels during vaginal hysterctomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uterine size &lt;12 weeks.&#xD;
&#xD;
          -  presence of benign cause for the hysterectomy e.g. fibroid uterus, perimenopausal&#xD;
             beeding not responding to medical treatment or complex endometrial hyperplasia without&#xD;
             atypia.&#xD;
&#xD;
          -  Absence of significant scarring in the pelvis from previous surgeries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or known gynecological malignancy.&#xD;
&#xD;
          -  uterine size &gt;12 weeks.&#xD;
&#xD;
          -  Endometriosis&#xD;
&#xD;
          -  Presence of adnexal mass.&#xD;
&#xD;
          -  cervix flushed with the vagina.&#xD;
&#xD;
          -  presence of significant scarring in the pelvic area from previous surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed A Tharwat, Ass. prof</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amr H Yehia, Ass.prof</last_name>
    <role>Study Chair</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alaa MA Karim El-din, ass. lect</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Abass</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>January 16, 2021</last_update_submitted>
  <last_update_submitted_qc>January 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Abass</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT03228654
org study id: Obs3514
nct id: NCT03228654
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof
      the development of alternative treatments, the incidence of hysterectomy doesn't appear to be
      declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined
      approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients
      with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy
      for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be
      performed in preference to abdominal hysterectomy.
A pilot prospective randomized clinical trial will be conducted at Ain shams University
      Maternity Hospital during the period from August 2016 to August 2018.

      A sample size of 50 cases will be recruited from women presenting to the outpatient
      gynecologic clinic of Ain Shams University Maternity Hospital planned to undergo vaginal
      hysterectomy for benign cause. selected patients should be in age group from 40 to 70 years.
      Uterus size should be < 12 weeks with absence of significant scarring in the pelvis from
      previous surgeries. Endometriosis, Adnexal mass, malignancy, thinned out cervix should be
      excluded. After approval of the ethical committee , a detailed explanation of the procedure
      will e informed to the participant & her approval to be involved in the study, an informed
      written consent will be taken. After that, included patients will be randomized into 2 groups
      each one include 25 patients. First group includes women who will undergo vaginal
      hysterectomy using monopolar electrocautery. Second group includes women who will undergo
      vaginal hysterectomy using Purohit's technique. Principles of Purohit technique are 1.
      Vaginal walls are incised by monopolar current(30-50W).2.A right angle forceps is used o
      elevate, hook, stretch, spread and retract all the lateral attacements of uterus & vessels
      from their posterior aspects; tissues are coagulated using bipolar current (45 W) and divided
      between the prongs of forceps. 3. conventional volume reduction maneuvers are used as
      associated procedures in cases of large uteri to create the parauterine space for bipolar
      forceps and scissors.

      Meanwhile the principles for vaginal hysterectomy using unipolar electrocautery are 1.Vaginal
      walls are incised by monopolar current(40 W) 2.A curved Bulldog clamp is applied just 0.5 cm
      lateral to uterine border along its attachements all through the pedicles. Then unipolar
      electrocautery (40 W) is applied to the pedicles along the lteral border of the uterus medial
      to the artery with maximum thickness 1 cm. 3. Uterine vessels are individually secured. 4.
      conventional volume reduction maneuvers are used as associated procedures in cases of large
      uteri to create the parauterine space for bipolar forceps and scissors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Intraoperative blood loss
time frame: 5 minutes after end if the procedure
description: assessment of blood loss by assessing blood loss amount in suction bottle as well as soaked guzes and towels.
measure: operative time
time frame: 5 minutes after end of the procedure
description: will be accounted from time of vaginal mucous membrane incision till closure of the vault.
measure: postoperative pain
time frame: 6 hours postoperative
description: pain scale will be used to assess pain
measure: postoperative pain
time frame: 12 hours postoperative
description: pain scale will be used to assess pain
measure: postoperative pain
time frame: 24 hours postoperative
description: pain scale will be used to assess pain
measure: Hospital stay
time frame: 1 week after procedure
description: number of days after the procedure the patient stay at the hospital
measure: postoperative complication
time frame: 1 week after procedure
description: bleeding
measure: postoperative complication
time frame: 1 week after procedure
description: burns
measure: postoperative complication
time frame: 1 week after procedure
description: haemtoma
measure: postoperative complication
time frame: 1 week after procedure
description: urinary tract infections
measure: postoperative complication
time frame: 1 week after procedure
description: surgical site infection
measure: postoperative complication
time frame: 1 week after procedure
description: blood transfusion
arm group label: Unipolar electrocautery
arm group type: Experimental
description: vaginal hysterectomy using Unipolar electrocautery
arm group label: Purohit's technique
arm group type: Active Comparator
description: Vaginal hysterectomy using Purohit's technique
intervention type: Procedure
intervention name: Unipolar Electrocautery sealing of vessels
description: Vaginal walls are incised by monoplar current (40 W)
A curved Bulldog Clamp is applied just 0.5 cm lateral to the uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lateral border of the uterus medial to the artery with maximum thickness 1 cm.
uterine vessels are individually secured.
Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space to approach the lateral attachements.
arm group label: Unipolar electrocautery
other name: Monopolar Electrocautery sealing of vessels
intervention type: Procedure
intervention name: Purohit technique for vaginal hysterectomy
description: using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy
arm group label: Purohit's technique
other name: Bipolar electrosurgical sealing of vessels during vaginal hysterctomy
criteria: 
gender: Female
gender based: Yes
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ahmed A Tharwat, Ass. prof
role: Study Director
affiliation: Ain Shams University
last name: Amr H Yehia, Ass.prof
role: Study Chair
affiliation: Ain Shams University
last name: Alaa MA Karim El-din, ass. lect
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Abass
investigator title: Lecturer
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code