xml: <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/NCT05983926</url>
    </required_header>
    <id_info>
      <org_study_id>STC-20230704</org_study_id>
      <nct_id>NCT05983926</nct_id>
    </id_info>
    <brief_title>To Explore the Changes of Nutritional Status, Immune Function, Intestinal Motility and Intestinal Flora in Patients With Constipation Before and After Surgical Treatment</brief_title>
    <official_title>The Intestinal Motility, Nutritional Status, Immune Function and Intestinal Environment of Patients Were Evaluated by Measuring BMI, Biochemical Tests and Nutritional Risk Related Questionnaires</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai 10th People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai 10th People's 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>
        Chronic constipation is a heterogeneous disease with multiple symptoms, and its incidence is&#xD;
        on the rise in many countries. It has become a common disease affecting the quality of life.&#xD;
        When these patients fail to respond to standardized and systematic non-surgical treatment,&#xD;
        and the relevant examination suggests that there are surgical indications, surgical treatment&#xD;
        should be considered. The cure rate of surgical treatment can reach 95%. The purpose of this&#xD;
        study was to evaluate the intestinal motility, nutritional status, immune function and&#xD;
        intestinal environment of patients by measuring BMI, biochemical tests and nutritional risk&#xD;
        related questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002)</measure>
      <time_frame>Baseline and 6 months after surgery</time_frame>
      <description>The full length of NRS2002 is called Nutritional Risk Screening2022. The minimum score is 0 and the maximum score is 3, with higher scores indicating higher nutritional risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST).</measure>
      <time_frame>Baseline and 6 months after surgery</time_frame>
      <description>The full name of MUST is Malnutrition Universal Screening Tool, score 0: low risk; Score 1: moderate risk; A score of 2 or higher is considered high risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment （MNA).</measure>
      <time_frame>Baseline and 6 months after surgery</time_frame>
      <description>Mini Nutritional Assessment (MNA) is defined as &quot;good nutritional status&quot; when MNA≥24. 17≤MNA &lt; 24, nutritional risk; MNA &lt; 17 indicated malnutrition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.</measure>
      <time_frame>Baseline and 6 months after surgery</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The changes of fecal microbiota were detected by 16SDNA sequencing.</measure>
      <time_frame>Baseline and 6 months after surgery</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitative changes in immune cells were determined by flow cytometry of blood samples.</measure>
      <time_frame>Baseline and 6 months after surgery</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Constipation</condition>
    <condition>Surgical Treatment</condition>
    <arm_group>
      <arm_group_label>Differences in conditions before and after surgical treatment of constipation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Subtotal colectomy was performed</intervention_name>
      <description>Colonic subtotal resection, also known as subtotal colectomy, is a surgical procedure used to treat colonic diseases such asconstipation, colon cancer, ulcerative colitis, and others.&#xD;
  The purpose of this surgery is to remove a portion of the colon in the patient's body. Unlike a total colectomy, which involves removing the entire colon, a subtotal colectomy only removes a portion of the colon. The procedure typically involves removing the diseased part of the colon and reconnecting the remaining colon. This allows for the preservation of some normal colonic function, enabling the patient to have regular bowel movements.</description>
      <arm_group_label>Differences in conditions before and after surgical treatment of constipation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Disease duration more than 6 years;&#xD;
  &#xD;
            -  Wexner constipation score &gt;15;&#xD;
  &#xD;
            -  No response to medical treatment, biofeedback and fecal microbiota transplantation;&#xD;
  &#xD;
            -  according to the surgical indications;&#xD;
  &#xD;
            -  All patients were informed of this study and signed the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suffering from mental disorders or cognitive impairment;&#xD;
  &#xD;
            -  With malignant tumors; -&#xD;
  &#xD;
            -  With history of gastrointestinal surgery;&#xD;
  &#xD;
            -  Complicated with other organ dysfunction;&#xD;
  &#xD;
            -  With immune system diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Le Wang, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Shanghai Tenth People's Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200071</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
      <investigator_full_name>Huanlong Qin</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983926
  org study id: STC-20230704
  nct id: NCT05983926
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Chronic constipation is a heterogeneous disease with multiple symptoms, and its incidence is
        on the rise in many countries. It has become a common disease affecting the quality of life.
        When these patients fail to respond to standardized and systematic non-surgical treatment,
        and the relevant examination suggests that there are surgical indications, surgical treatment
        should be considered. The cure rate of surgical treatment can reach 95%. The purpose of this
        study was to evaluate the intestinal motility, nutritional status, immune function and
        intestinal environment of patients by measuring BMI, biochemical tests and nutritional risk
        related questionnaires.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002)
  time frame: Baseline and 6 months after surgery
  description: The full length of NRS2002 is called Nutritional Risk Screening2022. The minimum score is 0 and the maximum score is 3, with higher scores indicating higher nutritional risk.
  measure: The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST).
  time frame: Baseline and 6 months after surgery
  description: The full name of MUST is Malnutrition Universal Screening Tool, score 0: low risk; Score 1: moderate risk; A score of 2 or higher is considered high risk.
  measure: The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment （MNA).
  time frame: Baseline and 6 months after surgery
  description: Mini Nutritional Assessment (MNA) is defined as "good nutritional status" when MNA≥24. 17≤MNA < 24, nutritional risk; MNA < 17 indicated malnutrition.
  measure: The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.
  time frame: Baseline and 6 months after surgery
  measure: The changes of fecal microbiota were detected by 16SDNA sequencing.
  time frame: Baseline and 6 months after surgery
  measure: Quantitative changes in immune cells were determined by flow cytometry of blood samples.
  time frame: Baseline and 6 months after surgery
  arm group label: Differences in conditions before and after surgical treatment of constipation
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Subtotal colectomy was performed
  description: Colonic subtotal resection, also known as subtotal colectomy, is a surgical procedure used to treat colonic diseases such asconstipation, colon cancer, ulcerative colitis, and others.
  The purpose of this surgery is to remove a portion of the colon in the patient's body. Unlike a total colectomy, which involves removing the entire colon, a subtotal colectomy only removes a portion of the colon. The procedure typically involves removing the diseased part of the colon and reconnecting the remaining colon. This allows for the preservation of some normal colonic function, enabling the patient to have regular bowel movements.
  arm group label: Differences in conditions before and after surgical treatment of constipation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Le Wang, Master
  role: Principal Investigator
  affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai 10th People's Hospital
  investigator full name: Huanlong Qin
  investigator title: Clinical Professor
  mesh term: Constipation
  sharing ipd: Undecided