<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/NCT03009604</url>
  </required_header>
  <id_info>
    <org_study_id>SIM</org_study_id>
    <nct_id>NCT03009604</nct_id>
  </id_info>
  <brief_title>Does Simethicone Improve Operative Field in Gynecological Operations</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which&#xD;
      thereby decreases the total colony count of bacteria, thus, decreasing peritoneal&#xD;
      contamination in case of bowel injury, improving the access to the surgical field and&#xD;
      facilitating intraoperative bowel manipulation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the degree of small &amp; large bowel preparation</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Benign Gynecologic Neoplasm</condition>
  <arm_group>
    <arm_group_label>Simethicone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enema</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>women take 3 rectal Enema (8:00 pm, 12:00 am &amp; 8:00 am) and to fast over night before the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simethicone</intervention_name>
    <description>Simethicone 40mg oral tablets</description>
    <arm_group_label>Simethicone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enema</intervention_name>
    <description>sodium dihydrogen phosphate dihydrate 19.2 gram &amp; disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water</description>
    <arm_group_label>Enema</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and&#xD;
        myomectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of allergic reaction to study drugs.&#xD;
&#xD;
          2. More than one scar of previous operation.&#xD;
&#xD;
          3. Suspicious of malignancy.&#xD;
&#xD;
          4. Psychiatric disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Altayeb Mostafa, MBBCh</last_name>
    <phone>00201003722811</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Altayeb Mostafa</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Altayeb Abd alal Mostafa Mohammad</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Neoplasms, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simethicone</mesh_term>
  </intervention_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/NCT03009604
org study id: SIM
nct id: NCT03009604
lead sponsor: 
has dmc: Yes
Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which
      thereby decreases the total colony count of bacteria, thus, decreasing peritoneal
      contamination in case of bowel injury, improving the access to the surgical field and
      facilitating intraoperative bowel manipulation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: the degree of small & large bowel preparation
time frame: intraoperative
arm group label: Simethicone
arm group type: Experimental
description: women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation
arm group label: Enema
arm group type: Active Comparator
description: women take 3 rectal Enema (8:00 pm, 12:00 am & 8:00 am) and to fast over night before the operation.
intervention type: Drug
intervention name: Simethicone
description: Simethicone 40mg oral tablets
arm group label: Simethicone
intervention type: Drug
intervention name: Enema
description: sodium dihydrogen phosphate dihydrate 19.2 gram & disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water
arm group label: Enema
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Altayeb Mostafa, MBBCh
phone: 00201003722811
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Altayeb Abd alal Mostafa Mohammad
investigator title: Dr
mesh term: Genital Neoplasms, Female
mesh term: Simethicone
sharing ipd: Undecided