<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/NCT03009747</url>
  </required_header>
  <id_info>
    <org_study_id>BaS-1611</org_study_id>
    <nct_id>NCT03009747</nct_id>
  </id_info>
  <brief_title>A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery</brief_title>
  <acronym>PMCRBDSPS</acronym>
  <official_title>A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First People's Hospital of Changzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>the first affiliated hospital of Jiamusi university</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of the Chinese Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University (Qingdao)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research plans to collect rectal cancer patients after sphincter-preserving surgery from&#xD;
      14 institutions in China mainland, observe the incidence and risk factors about bowel&#xD;
      dysfunction after operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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 bowel dysfunction after sphincter-preserving surgery</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk factors of bowel dysfunction after sphincter-preserving surgery</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of each symptoms of bowel dysfunction</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognosis of bowel dysfunction after sphincter-preserving surgery</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bowel dysfunction after sphincter-preserving surgery</measure>
    <time_frame>one year</time_frame>
    <description>comparing incidences between high and low anastomsis site</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">460</enrollment>
  <condition>Bowel Dysfunction</condition>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>sphincter-preserving surgery</arm_group_label>
    <description>Patients meet the inclusion criteria will be enrolled into this observing group</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Rectal cancer patients who accept sphincter-preserving surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Adenocarcinoma confirmed by pathology&#xD;
&#xD;
          3. Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by&#xD;
             hard sigmoidoscope.&#xD;
&#xD;
          4. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).&#xD;
&#xD;
          5. The operation is estimated to be sphincter-preserving.&#xD;
&#xD;
          6. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤&#xD;
             2.&#xD;
&#xD;
          7. The estimated life time is not less than one year.&#xD;
&#xD;
          8. The patient agree to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient refuse to follow research plan.&#xD;
&#xD;
          2. Emergency case&#xD;
&#xD;
          3. Pregnant and lactating female patient&#xD;
&#xD;
          4. The patient did not accept radical resection.&#xD;
&#xD;
          5. The patient did not accept first stage resection and anastomosis.&#xD;
&#xD;
          6. The patient has experienced anal-rectal surgery.&#xD;
&#xD;
          7. The patient has experienced left colon surgery.&#xD;
&#xD;
          8. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.&#xD;
&#xD;
          9. The patient was diagnosed with cognitive or communicative obstacles.&#xD;
&#xD;
         10. The patient was diagnosed with serious repeated infection or other concomitance&#xD;
             diseases.&#xD;
&#xD;
         11. The patient has participated other medical research which may affect his/her bowel&#xD;
             function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingjiang Ye, M.D./ PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese Society of Colon and Rectal Surgeons</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fan Liu, M.D.</last_name>
    <phone>+86-188-1159-0087</phone>
    <email>liufan_md@126.com</email>
  </overall_contact>
  <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>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>anterior resection syndrome</keyword>
  <keyword>sphincter-preserving surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
  </condition_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/NCT03009747
org study id: BaS-1611
nct id: NCT03009747
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This research plans to collect rectal cancer patients after sphincter-preserving surgery from
      14 institutions in China mainland, observe the incidence and risk factors about bowel
      dysfunction after operation.
observational model: Cohort
time perspective: Prospective
measure: Incidence of bowel dysfunction after sphincter-preserving surgery
time frame: one year
measure: Risk factors of bowel dysfunction after sphincter-preserving surgery
time frame: one year
measure: Incidence of each symptoms of bowel dysfunction
time frame: one year
measure: Prognosis of bowel dysfunction after sphincter-preserving surgery
time frame: one year
measure: Incidence of bowel dysfunction after sphincter-preserving surgery
time frame: one year
description: comparing incidences between high and low anastomsis site
arm group label: sphincter-preserving surgery
description: Patients meet the inclusion criteria will be enrolled into this observing group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yingjiang Ye, M.D./ PhD
role: Study Chair
affiliation: Chinese Society of Colon and Rectal Surgeons
last name: Fan Liu, M.D.
phone: +86-188-1159-0087
email: liufan_md@126.com
responsible party type: Sponsor
mesh term: Rectal Neoplasms
mesh term: Intestinal Diseases
mesh term: Gastrointestinal Diseases
sharing ipd: Yes