<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/NCT04460404</url>
  </required_header>
  <id_info>
    <org_study_id>20200626</org_study_id>
    <nct_id>NCT04460404</nct_id>
  </id_info>
  <brief_title>The Predictive Value of Alarm Symptoms in Patients With Function Constipation Based on Roman IV</brief_title>
  <official_title>The Predictive Value of Alarm Symptoms in Patients With Function Constipation Based on Roman IV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital of Xi'an Jiaotong University</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>
      Functional constipation is one of the five most common gastrointestinal diseases in&#xD;
      outpatient visits. It is known that the global prevalence of chronic constipation is&#xD;
      estimated to be 14%, and the prevalence of adults in my country is about 4.0% to 10.0%. It is&#xD;
      generally believed that the diagnosis of functional constipation is based on a thorough&#xD;
      history and physical examination. However, these standards are mainly used in clinical&#xD;
      research and are not always strictly applicable to clinical practice. Therefore, in addition&#xD;
      to the main symptoms, the medical history should include evidence of organic diseases (alarm&#xD;
      symptoms). Rectal bleeding, anemia, weight loss, fever, family history of colon cancer and&#xD;
      the age of onset over 50 years are considered as alarm symptoms of severe gastrointestinal&#xD;
      diseases, but the value of alarm symptoms in distinguishing organic diseases from functional&#xD;
      diseases is still not Ok, further research is still needed. In 2016, the Rome IV standard was&#xD;
      updated and released, with some updates in the definition and diagnostic criteria for&#xD;
      functional constipation. However, there are few studies on the clinical practice based on&#xD;
      Rome IV. The advantages and disadvantages of adjusting the diagnostic criteria of Rome IV&#xD;
      compared to Rome III in clinical application are still unclear. In order to evaluate the&#xD;
      predictive value of the alarm symptoms of functional constipation based on Roman IV, we&#xD;
      designed this cross-sectional study. It is used to evaluate the predictive value of alarm&#xD;
      symptoms for functional constipation and organic bowel disease, as well as the predictive&#xD;
      value of alarm symptoms of benign and malignant intestinal diseases related to functional&#xD;
      constipation symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the predictive value of alarm symptoms for functional constipation</measure>
    <time_frame>2020/12/31</time_frame>
    <description>When a patient with constipation is accompanied by one or several alarm symptoms, the result of colonoscopy is confirmed as organic bowel disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive value of warning symptoms to malignant intestinal tumors</measure>
    <time_frame>2020/12/31</time_frame>
    <description>When a patient with constipation is accompanied by one or more alarm symptoms, the result of colonoscopy is confirmed as malignant intestinal tumor</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Function Constipation</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle consultation</intervention_name>
    <description>Collect relevant data of patients included in the study through outpatient consultation, telephone follow-up, questionnaire follow-up, etc., including:&#xD;
Basic information&#xD;
Digestive tract symptoms:&#xD;
A constipation-related symptoms B abnormal symptoms&#xD;
Fecal traits&#xD;
Lifestyle habits&#xD;
Others</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with constipation that meet the Rome IV diagnostic criteria are the subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with constipation that meet the diagnostic criteria for functional&#xD;
             constipation in Rome III or IV (specific conditions are as follows) (1) Must include&#xD;
             two or more of the following:&#xD;
&#xD;
               1. More than 25% of bowel movements feel laborious;&#xD;
&#xD;
               2. Over 25% of the bowel movements are dry ball dung or hard dung; (Bristol Manure&#xD;
                  Character Scale Type 1-2)&#xD;
&#xD;
               3. More than 25% of bowel movements have an inexhaustible feeling;&#xD;
&#xD;
               4. More than 25% of bowel movements require manual assistance;&#xD;
&#xD;
               5. More than 25% of bowel movements need to be assisted by manual techniques (such&#xD;
                  as assisting bowel movements with fingers and basin support);&#xD;
&#xD;
               6. Less than 3 times per week (spontaneous defecation). (2) Dirty feces rarely occur&#xD;
                  when laxatives are not used. (3) Does not meet the diagnostic criteria for&#xD;
                  irritable bowel syndrome. (Symptoms appear at least 6 months before diagnosis,&#xD;
                  and meet the above (existence) diagnostic criteria within the past 3 months)&#xD;
&#xD;
          2. Age ≥18 years old;&#xD;
&#xD;
          3. From 2020.07 to 2020.12, visit the outpatient clinic of our hospital and perform&#xD;
             colonoscopy;&#xD;
&#xD;
          4. Blood routine, fecal routine and fecal occult blood examination within 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inflammatory bowel disease, celiac disease and other organic intestinal diseases,&#xD;
             history of metabolic diseases (abnormal thyroid function and diabetes, etc.);&#xD;
&#xD;
          2. Severe neurological, mental and psychological diseases, or those with severe organ&#xD;
             dysfunction;&#xD;
&#xD;
          3. Abdominal surgery;&#xD;
&#xD;
          4. Patients during pregnancy, possible pregnancy and lactation;&#xD;
&#xD;
          5. Those who have a history of colonoscopy within the past 6 months, and those who have&#xD;
             evaluated intestinal status;&#xD;
&#xD;
          6. Refuse to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>The second affiliated hospital of xi'an jiaotong university</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_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/NCT04460404
org study id: 20200626
nct id: NCT04460404
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Functional constipation is one of the five most common gastrointestinal diseases in
      outpatient visits. It is known that the global prevalence of chronic constipation is
      estimated to be 14%, and the prevalence of adults in my country is about 4.0% to 10.0%. It is
      generally believed that the diagnosis of functional constipation is based on a thorough
      history and physical examination. However, these standards are mainly used in clinical
      research and are not always strictly applicable to clinical practice. Therefore, in addition
      to the main symptoms, the medical history should include evidence of organic diseases (alarm
      symptoms). Rectal bleeding, anemia, weight loss, fever, family history of colon cancer and
      the age of onset over 50 years are considered as alarm symptoms of severe gastrointestinal
      diseases, but the value of alarm symptoms in distinguishing organic diseases from functional
      diseases is still not Ok, further research is still needed. In 2016, the Rome IV standard was
      updated and released, with some updates in the definition and diagnostic criteria for
      functional constipation. However, there are few studies on the clinical practice based on
      Rome IV. The advantages and disadvantages of adjusting the diagnostic criteria of Rome IV
      compared to Rome III in clinical application are still unclear. In order to evaluate the
      predictive value of the alarm symptoms of functional constipation based on Roman IV, we
      designed this cross-sectional study. It is used to evaluate the predictive value of alarm
      symptoms for functional constipation and organic bowel disease, as well as the predictive
      value of alarm symptoms of benign and malignant intestinal diseases related to functional
      constipation symptoms.
observational model: Case-Only
time perspective: Prospective
measure: the predictive value of alarm symptoms for functional constipation
time frame: 2020/12/31
description: When a patient with constipation is accompanied by one or several alarm symptoms, the result of colonoscopy is confirmed as organic bowel disease
measure: Predictive value of warning symptoms to malignant intestinal tumors
time frame: 2020/12/31
description: When a patient with constipation is accompanied by one or more alarm symptoms, the result of colonoscopy is confirmed as malignant intestinal tumor
intervention type: Behavioral
intervention name: Lifestyle consultation
description: Collect relevant data of patients included in the study through outpatient consultation, telephone follow-up, questionnaire follow-up, etc., including:
Basic information
Digestive tract symptoms:
A constipation-related symptoms B abnormal symptoms
Fecal traits
Lifestyle habits
Others
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
facility: 
country: China
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: No