<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/NCT03251677</url>
  </required_header>
  <id_info>
    <org_study_id>MD/16.12.51</org_study_id>
    <nct_id>NCT03251677</nct_id>
  </id_info>
  <brief_title>Total Laparoscopic Hysterectomy vs Minilap Hysterectomy</brief_title>
  <official_title>A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      The objective of this study is to compare the perioperative outcomes between mini-lap&#xD;
      hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized open-label study was conducted. Women &gt;18 years of age undergoing&#xD;
      TLH because of benign indications were recruited. Patients were randomized for either TLH&#xD;
      (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal&#xD;
      Pfannenstiel incision.&#xD;
&#xD;
      Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks&#xD;
      gestation. Exclusion criteria adopted were patients with enlarged uterus &lt; 12 weeks,&#xD;
      suspected malignancy and large adnexal masses (&gt;5cm). Peri-operative outcomes were compared.&#xD;
&#xD;
      Written informed consent was obtained from all the patients and the Departmental Ethical&#xD;
      Committee approved the study. Patients from OB/GYN Mansoura University Hospital were&#xD;
      enrolled. All the operations were performed by at least one of the consultants included as&#xD;
      authors in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative Time (min)</measure>
    <time_frame>Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)</time_frame>
    <description>Time in minutes taken for total hysterectomy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated blood loss (mL)</measure>
    <time_frame>Through surgical intervention completion</time_frame>
    <description>Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early postoperative complications</measure>
    <time_frame>Within 30 days after operation</time_frame>
    <description>Related complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hysteromyoma</condition>
  <arm_group>
    <arm_group_label>Total laparo hysterectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mini-lap hysterectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical procedure, Hysterectomy</intervention_name>
    <description>Surgical removal of the uterus</description>
    <arm_group_label>Mini-lap hysterectomy</arm_group_label>
    <arm_group_label>Total laparo hysterectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mobile uterus.&#xD;
&#xD;
          -  Uterine size up to 12 weeks gestation.&#xD;
&#xD;
          -  Benign lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enlarged uterus &gt; 12 weeks gestation.&#xD;
&#xD;
          -  Suspected malignancy.&#xD;
&#xD;
          -  Large adnexal masses.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tarek Shokeir</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tarek Shokeir</name>
      <address>
        <city>Mansoura</city>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>September 27, 2019</last_update_submitted>
  <last_update_submitted_qc>September 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Tarek Shokeir</investigator_full_name>
    <investigator_title>Prof. Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Sharing up to scientific publication of a manuscript</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Up to scientific publication of a manuscript</ipd_time_frame>
    <ipd_access_criteria>Personal</ipd_access_criteria>
    <ipd_url>http://tarek.shokeir@gmail.com</ipd_url>
  </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/NCT03251677
org study id: MD/16.12.51
nct id: NCT03251677
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to compare the perioperative outcomes between mini-lap
      hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.
A prospective randomized open-label study was conducted. Women >18 years of age undergoing
      TLH because of benign indications were recruited. Patients were randomized for either TLH
      (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal
      Pfannenstiel incision.

      Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks
      gestation. Exclusion criteria adopted were patients with enlarged uterus < 12 weeks,
      suspected malignancy and large adnexal masses (>5cm). Peri-operative outcomes were compared.

      Written informed consent was obtained from all the patients and the Departmental Ethical
      Committee approved the study. Patients from OB/GYN Mansoura University Hospital were
      enrolled. All the operations were performed by at least one of the consultants included as
      authors in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative Time (min)
time frame: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
description: Time in minutes taken for total hysterectomy
measure: Estimated blood loss (mL)
time frame: Through surgical intervention completion
description: Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values
measure: Early postoperative complications
time frame: Within 30 days after operation
description: Related complications
arm group label: Total laparo hysterectomy
arm group type: Active Comparator
description: Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)
arm group label: Mini-lap hysterectomy
arm group type: Active Comparator
description: Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)
intervention type: Procedure
intervention name: Surgical procedure, Hysterectomy
description: Surgical removal of the uterus
arm group label: Mini-lap hysterectomy
arm group label: Total laparo hysterectomy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tarek Shokeir
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Tarek Shokeir
investigator title: Prof. Obstetrics & Gynecology
sharing ipd: Yes
ipd description: Sharing up to scientific publication of a manuscript
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Up to scientific publication of a manuscript
ipd access criteria: Personal
ipd url: http://tarek.shokeir@gmail.com