<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/NCT03036111</url>
  </required_header>
  <id_info>
    <org_study_id>mansourau20172</org_study_id>
    <nct_id>NCT03036111</nct_id>
  </id_info>
  <brief_title>Effect of Topical Trimebutine on Pain After Hemorrhoidectomy</brief_title>
  <official_title>Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      Trimebutine acts through smooth muscle relaxation. It is presumed that the topical&#xD;
      application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure&#xD;
      by relaxing the internal anal sphincter spasm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized trial will be carried out to investigate the effect of trimebutine on pain after&#xD;
      Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which&#xD;
      usually occurs after excisional hemorrhoidectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Unavailability of Triembutine maleate&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2018</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessment assessed using visual analogue score from 0-10</measure>
    <time_frame>Pain will be assessed at 12 hours after the procedure</time_frame>
    <description>Anal pain will be assessed using visual analogue score from 0-10</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Hemorrhoidectomy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before</description>
  </arm_group>
  <arm_group>
    <arm_group_label>trimebutine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimebutine</intervention_name>
    <description>Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.</description>
    <arm_group_label>trimebutine</arm_group_label>
    <other_name>Gastreg suppository</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hemorrhoidectomy</intervention_name>
    <description>Patients will undergo classic Milliagn-Morgan hemorrhoidectomy</description>
    <arm_group_label>Hemorrhoidectomy</arm_group_label>
    <arm_group_label>trimebutine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders aging between 18-70 years with grade III/VI internal&#xD;
             hemorrhoids will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with grade I/II internal hemorrhoids or external hemorrhoids.&#xD;
&#xD;
          -  Patients with associated anorectal pathology such as anal fissure, anal fistula,&#xD;
             rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\&#xD;
&#xD;
          -  Patients with recurrent hemorrhoids after previous surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh H Emile, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university hospital</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Sameh Emile</investigator_full_name>
    <investigator_title>Lecturer of general surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trimebutine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03036111
org study id: mansourau20172
nct id: NCT03036111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Trimebutine acts through smooth muscle relaxation. It is presumed that the topical
      application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure
      by relaxing the internal anal sphincter spasm.
A randomized trial will be carried out to investigate the effect of trimebutine on pain after
      Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which
      usually occurs after excisional hemorrhoidectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Pain assessment assessed using visual analogue score from 0-10
time frame: Pain will be assessed at 12 hours after the procedure
description: Anal pain will be assessed using visual analogue score from 0-10
arm group label: Hemorrhoidectomy
arm group type: Sham Comparator
description: Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before
arm group label: trimebutine
arm group type: Active Comparator
description: Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.
intervention type: Drug
intervention name: Trimebutine
description: Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.
arm group label: trimebutine
other name: Gastreg suppository
intervention type: Procedure
intervention name: Hemorrhoidectomy
description: Patients will undergo classic Milliagn-Morgan hemorrhoidectomy
arm group label: Hemorrhoidectomy
arm group label: trimebutine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sameh H Emile, M.D.
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Emile
investigator title: Lecturer of general surgery
mesh term: Hemorrhoids
mesh term: Trimebutine
sharing ipd: No