<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/NCT02984176</url>
  </required_header>
  <id_info>
    <org_study_id>Simethicone and laparoscopy</org_study_id>
    <nct_id>NCT02984176</nct_id>
  </id_info>
  <brief_title>Simethicone: Does it Improve Operative Field and Postoperative Pain?</brief_title>
  <official_title>Simethicone and Gynecological Laparoscopies: Does it Improve Operative Field and Postoperative Pain?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and&#xD;
      abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.&#xD;
&#xD;
      The investigators objective is to evaluate the efficacy and safety of preoperative oral&#xD;
      simethicone for bowel preparation in gynecological laparoscopies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal&#xD;
      discomfort, and abdominal pain by promoting the clearance of excessive gas along the&#xD;
      gastrointestinal tract.&#xD;
&#xD;
      Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel&#xD;
      preparation in gynecological laparoscopies.&#xD;
&#xD;
      Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to&#xD;
      receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome&#xD;
      measure will be the overall exposure of the surgical field and pain scoring. Assessment of&#xD;
      the overall exposure of the surgical field was done using a five-point scale (poor,&#xD;
      sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for&#xD;
      assessment of postoperative pain and verbal analog scoring was used for assessment of patient&#xD;
      satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>five-point scale</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The degree of bowel preparation</measure>
    <time_frame>1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Simethicone</condition>
  <arm_group>
    <arm_group_label>Simethicone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simethicone Tab 40 mg</intervention_name>
    <description>3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.</description>
    <arm_group_label>Simethicone</arm_group_label>
    <other_name>Disflatyl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Tablets</intervention_name>
    <description>3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile patients&#xD;
&#xD;
          -  aged 20 - 40 years old&#xD;
&#xD;
          -  scheduled for laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women were excluded from the study if patients had one or more of the following:&#xD;
&#xD;
               -  scar of previous operation, uterine mass, severe endometriosis, suspicion of&#xD;
                  malignancy, history of allergic reaction to study drugs, psychiatric disorders&#xD;
                  and patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>Kamal Mohamed Zahran</investigator_full_name>
    <investigator_title>Assistant professor of Obstetrics &amp; Gynecology, Faculty of Medicine, Consultant and vice director, Women's Health Hospital, Assiut University, Egypt</investigator_title>
  </responsible_party>
  <keyword>Simethicone</keyword>
  <keyword>Laparoscopies</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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>Yes</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/NCT02984176
org study id: Simethicone and laparoscopy
nct id: NCT02984176
lead sponsor: 
has dmc: No
Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and
      abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.

      The investigators objective is to evaluate the efficacy and safety of preoperative oral
      simethicone for bowel preparation in gynecological laparoscopies.
Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal
      discomfort, and abdominal pain by promoting the clearance of excessive gas along the
      gastrointestinal tract.

      Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel
      preparation in gynecological laparoscopies.

      Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to
      receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome
      measure will be the overall exposure of the surgical field and pain scoring. Assessment of
      the overall exposure of the surgical field was done using a five-point scale (poor,
      sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for
      assessment of postoperative pain and verbal analog scoring was used for assessment of patient
      satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: five-point scale
time frame: 1 hour
measure: The degree of bowel preparation
time frame: 1 hour
measure: VAS
time frame: 24 hours
measure: Patient satisfaction
time frame: 24 hours
arm group label: Simethicone
arm group type: Active Comparator
description: Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.
arm group label: placebo
arm group type: Placebo Comparator
description: Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.
intervention type: Drug
intervention name: Simethicone Tab 40 mg
description: 3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.
arm group label: Simethicone
other name: Disflatyl
intervention type: Drug
intervention name: Placebo Tablets
description: 3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.
arm group label: placebo
other name: Placebo
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: Kamal Mohamed Zahran
investigator title: Assistant professor of Obstetrics & Gynecology, Faculty of Medicine, Consultant and vice director, Women's Health Hospital, Assiut University, Egypt
mesh term: Pain, Postoperative
mesh term: Simethicone
sharing ipd: Yes