<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/NCT01661829</url>
  </required_header>
  <id_info>
    <org_study_id>KSVHCRC trial-01</org_study_id>
    <secondary_id>Colorectal disease</secondary_id>
    <nct_id>NCT01661829</nct_id>
  </id_info>
  <brief_title>An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients</brief_title>
  <official_title>A Randomised Controlled Trial for the Effect of Biofeedback Therapy for the Preveintion of Anterior Resection Syndrome in Rectal Cancer Patients Who Have Undergone Low Anterior Resection With Total Mesorectal Excision Following Neoadjuvant Chemoradiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients who underwent sphincter preserving surgery with toal mesorectal excision and&#xD;
      diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators&#xD;
      would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal&#xD;
      function after stoma closure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of anterior resection syndrome after stoma closure</measure>
    <time_frame>1 year after stoma closure</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Biofeedback</arm_group_label>
    <description>Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kegel</arm_group_label>
    <description>Patients will be trained to take excersise for their anal sphincter by Kegel.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Rectal cancer patients who underwent sphincter saving surgery with total mesorectal&#xD;
        excision and diverting stoma after neoadjuvant chemoradiation therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  rectal cancer patients&#xD;
&#xD;
          -  neoadjuvant chemoradiation therapy (+)&#xD;
&#xD;
          -  sphincter saving surgery with total mesorectal excision (+)&#xD;
&#xD;
          -  temporary loop stoma (+)&#xD;
&#xD;
          -  adult who is 17 years or older&#xD;
&#xD;
          -  patinet who aggree with our study&#xD;
&#xD;
          -  if woman is childbearing age, her pregnancy test shoud be indentified 'negative'&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have been enrolled to other clinical studies related to this study&#xD;
&#xD;
          -  patients who underwent diverting stoma before neoadjuvant chemoradiation&#xD;
&#xD;
          -  temporary end -ostomy (+)&#xD;
&#xD;
          -  uncontrolled metabolic or systemic disease&#xD;
&#xD;
          -  patients who do not understand the purpose of this study because of dementia or&#xD;
             pshycologic problem&#xD;
&#xD;
          -  MRSA or Clostridium difficille (+)&#xD;
&#xD;
          -  Pregnant or during breast feeding&#xD;
&#xD;
          -  serious complication after sphincter saving surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea</name>
      <address>
        <city>Suwon</city>
        <zip>442-723</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Kye Bong-Hyeon</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_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/NCT01661829
org study id: KSVHCRC trial-01
secondary id: Colorectal disease
nct id: NCT01661829
lead sponsor: 
has dmc: Yes
In patients who underwent sphincter preserving surgery with toal mesorectal excision and
      diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators
      would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal
      function after stoma closure.
observational model: Cohort
time perspective: Prospective
measure: Incidence of anterior resection syndrome after stoma closure
time frame: 1 year after stoma closure
arm group label: Biofeedback
description: Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)
arm group label: Kegel
description: Patients will be trained to take excersise for their anal sphincter by Kegel.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Kye Bong-Hyeon
investigator title: Assistant Clinical Professor
mesh term: Rectal Neoplasms