<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/NCT04485780</url>
  </required_header>
  <id_info>
    <org_study_id>1-107-05-042</org_study_id>
    <nct_id>NCT04485780</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin Injection in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study</brief_title>
  <official_title>The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tri-Service General Hospital</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>
      This is a prospective, randomized study, which anticipatedly recruited 60 patients in the&#xD;
      outpatient department who need hemorrhoidectomy from January 2019 to December 2019. After&#xD;
      obtaining those patients' consent in the clinic, they were randomly assigned to two groups at&#xD;
      a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group&#xD;
      received Botulinum toxin injection during the outpatient clinic one week before the&#xD;
      operation(experimental group, EG), and the other group received injection during the&#xD;
      operation(control group, CG). The two groups were compared for the influence of postoperative&#xD;
      pain control and wound healing rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 8, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>one week after operation</measure>
    <time_frame>1 weel</time_frame>
    <description>The degree of postoperative pain is assessed by visual analog scale (VAS). After operation, we record patients' average VAS score and maximum VAS score every day until one week after surgery.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin injection during surgery</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this group underwent Botulinum toxin injection during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum toxin injection one week before surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>botulinum toxin type A</intervention_name>
    <description>In the outpatient department, patients who need hemorrhoidectomy were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.</description>
    <arm_group_label>Botulinum toxin injection during surgery</arm_group_label>
    <arm_group_label>Botulinum toxin injection one week before surgery</arm_group_label>
    <other_name>Botox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with age over 20 but under 80, who need to undergo hemorrhoidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under the age of 20&#xD;
&#xD;
          -  patients with nonsteroidal anti-inflammatory drugs (NSAIDs) allergy or sensitivity&#xD;
&#xD;
          -  patients with Botulinum toxin allergy or sensitivity&#xD;
&#xD;
          -  patients with dialysis or renal insufficiency&#xD;
&#xD;
          -  pregnant and breastfeeding women&#xD;
&#xD;
          -  vulnerable population&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yi-Chiao Cheng</last_name>
    <phone>+886912959022</phone>
    <email>ndmcjoe@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tri-Service General Hospital, National Defense Medical Center</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi-Chiao Cheng</last_name>
      <phone>+886912959022</phone>
      <email>ndmcjoe@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
    <investigator_full_name>Yi-Chiao Cheng</investigator_full_name>
    <investigator_title>Attending surgeon, division of colon and rectal surgery</investigator_title>
  </responsible_party>
  <keyword>hemorrhoidectomy</keyword>
  <keyword>botulinum toxin</keyword>
  <keyword>pain</keyword>
  <keyword>wound healing</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>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04485780
org study id: 1-107-05-042
nct id: NCT04485780
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized study, which anticipatedly recruited 60 patients in the
      outpatient department who need hemorrhoidectomy from January 2019 to December 2019. After
      obtaining those patients' consent in the clinic, they were randomly assigned to two groups at
      a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group
      received Botulinum toxin injection during the outpatient clinic one week before the
      operation(experimental group, EG), and the other group received injection during the
      operation(control group, CG). The two groups were compared for the influence of postoperative
      pain control and wound healing rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: one week after operation
time frame: 1 weel
description: The degree of postoperative pain is assessed by visual analog scale (VAS). After operation, we record patients' average VAS score and maximum VAS score every day until one week after surgery.
arm group label: Botulinum toxin injection during surgery
arm group type: Placebo Comparator
description: Patients in this group underwent Botulinum toxin injection during surgery
arm group label: Botulinum toxin injection one week before surgery
arm group type: Experimental
description: Patients in this group underwent Botulinum toxin injection at the outpatient clinic one week before surgery
intervention type: Biological
intervention name: botulinum toxin type A
description: In the outpatient department, patients who need hemorrhoidectomy were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.
arm group label: Botulinum toxin injection during surgery
arm group label: Botulinum toxin injection one week before surgery
other name: Botox
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yi-Chiao Cheng
phone: +886912959022
email: ndmcjoe@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yi-Chiao Cheng
investigator title: Attending surgeon, division of colon and rectal surgery
mesh term: Pain, Postoperative
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA